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Bone & Joint Open
Vol. 4, Issue 3 | Pages 158 - 167
10 Mar 2023
Landers S Hely R Hely A Harrison B Page RS Maister N Gwini SM Gill SD

Aims. This study investigated the effects of transcatheter arterial embolization (TAE) on pain, function, and quality of life in people with early-stage symptomatic knee osteoarthritis (OA) compared to a sham procedure. Methods. A total of 59 participants with symptomatic Kellgren-Lawrence grade 2 knee OA were randomly allocated to TAE or a sham procedure. The intervention group underwent TAE of one or more genicular arteries. The control group received a blinded sham procedure. The primary outcome was knee pain at 12 months according to the Knee injury and Osteoarthritis Outcome Score (KOOS) pain scale. Secondary outcomes included self-reported function and quality of life (KOOS, EuroQol five-dimension five-level questionnaire (EQ-5D-5L)), self-reported Global Change, six-minute walk test, 30-second chair stand test, and adverse events. Subgroup analyses compared participants who received complete embolization of all genicular arteries (as distinct from embolization of some arteries) (n = 17) with the control group (n = 29) for KOOS and Global Change scores at 12 months. Continuous variables were analyzed with quantile regression, adjusting for baseline scores. Dichotomized variables were analyzed with chi-squared tests. Results. Overall, 58 participants provided questionnaire data at 12 months. No significant differences were found for the primary and secondary outcomes, with both groups improving following the procedure. At 12 months, KOOS pain scores improved by 41.3% and 29.4% in the intervention and control groups, respectively. No adverse events occurred. Subgroup analysis indicated that the complete embolization group had significantly better KOOS Sports and Recreation, KOOS Quality of Life, and Global Change scores than the control group; 76.5% of participants who received complete embolization reporting being moderately or much better compared to 37.9% of the control group. Conclusion. TAE might produce benefits above placebo, but only when complete embolization of all genicular arteries is performed. Further comparative studies are required before definitive conclusions regarding the effectiveness of TAE can be made. Level of evidence: I. Cite this article: Bone Jt Open 2023;4(3):158–167


The Bone & Joint Journal
Vol. 103-B, Issue 10 | Pages 1578 - 1585
1 Oct 2021
Abram SGF Sabah SA Alvand A Price AJ

Aims. To compare rates of serious adverse events in patients undergoing revision knee arthroplasty with consideration of the indication for revision (urgent versus elective indications), and compare these with primary arthroplasty and re-revision arthroplasty. Methods. Patients undergoing primary knee arthroplasty were identified in the national Hospital Episode Statistics (HES) between 1 April 1997 to 31 March 2017. Subsequent revision and re-revision arthroplasty procedures in the same patients and same knee were identified. The primary outcome was 90-day mortality and a logistic regression model was used to investigate factors associated with 90-day mortality and secondary adverse outcomes, including infection (undergoing surgery), pulmonary embolism, myocardial infarction, and stroke. Urgent indications for revision arthroplasty were defined as infection or fracture, and all other indications (e.g. loosening, instability, wear) were included in the elective indications cohort. Results. A total of 939,021 primary knee arthroplasty procedures were included (939,021 patients), of which 40,854 underwent subsequent revision arthroplasty, and 9,100 underwent re-revision arthroplasty. Revision surgery for elective indications was associated with a 90-day rate of mortality of 0.44% (135/30,826; 95% confidence interval (CI) 0.37 to 0.52) which was comparable to primary knee arthroplasty (0.46%; 4,292/939,021; 95% CI 0.44 to 0.47). Revision arthroplasty for infection was associated with a much higher mortality of 2.04% (184/9037; 95% CI 1.75 to 2.35; odds ratio (OR) 3.54; 95% CI 2.81 to 4.46), as was revision for periprosthetic fracture at 5.25% (52/991; 95% CI 3.94 to 6.82; OR 6.23; 95% CI 4.39 to 8.85). Higher rates of pulmonary embolism, myocardial infarction, and stroke were also observed in the infection and fracture cohort. Conclusion. Patients undergoing revision arthroplasty for urgent indications (infection or fracture) are at higher risk of mortality and serious adverse events in comparison to primary knee arthroplasty and revision arthroplasty for elective indications. These findings will be important for patient consent and shared decision-making and should inform service design for this patient cohort. Cite this article: Bone Joint J 2021;103-B(10):1578–1585


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_7 | Pages 34 - 34
1 Jul 2022
Abram S Sabah S Alvand A Price A
Full Access

Abstract. Introduction. The objective of this study was to determine rates of serious adverse events in patients undergoing revision knee arthroplasty with consideration of the indication for revision and compare these with primary knee arthroplasty. Methodology. Primary and revision arthroplasty procedures were identified in the national Hospital Episode Statistics and were linked by patient and side. A logistic regression model was used to investigate factors associated with 90-day mortality (primary outcome) and secondary serious adverse outcomes. Urgent indications for revision arthroplasty were defined as infection or fracture; other indications (e.g. loosening, instability, wear) were included in the elective cohort. Results. 939,021 primary knee arthroplasty and 40,584 revision cases were included. Revision surgery for elective indications was associated with a 90-day rate of mortality of 0.44% (95% CI 0.37-0.52) which was comparable to primary knee arthroplasty (0.46%; 95% CI 0.44-0.47). Revision arthroplasty for infection, however, was associated with a much higher mortality of 2.04% (95% CI 1.75-2.35; odds ratio [OR] 3.54; 95% CI 2.81-4.46), as was revision for periprosthetic fracture at 5.25% (95% CI 3.94-6.82; OR 6.23; 95% CI 4.39-8.85). Higher rates of PE, MI, and stroke were observed in the infection and fracture cohort. Conclusion. Patients presenting with infection of a knee arthroplasty or a periprosthetic fracture are at very high risk of adverse events. It is important that acute hospital services and tertiary referral centres caring for these patients are appropriately supported to ensure appropriate urgency with an anticipation for increased care requirements


The Bone & Joint Journal
Vol. 105-B, Issue 8 | Pages 880 - 887
1 Aug 2023
Onodera T Momma D Matsuoka M Kondo E Suzuki K Inoue M Higano M Iwasaki N

Aims. Implantation of ultra-purified alginate (UPAL) gel is safe and effective in animal osteochondral defect models. This study aimed to examine the applicability of UPAL gel implantation to acellular therapy in humans with cartilage injury. Methods. A total of 12 patients (12 knees) with symptomatic, post-traumatic, full-thickness cartilage lesions (1.0 to 4.0 cm. 2. ) were included in this study. UPAL gel was implanted into chondral defects after performing bone marrow stimulation technique, and assessed for up to three years postoperatively. The primary outcomes were the feasibility and safety of the procedure. The secondary outcomes were self-assessed clinical scores, arthroscopic scores, tissue biopsies, and MRI-based estimations. Results. No obvious adverse events related to UPAL gel implantation were observed. Self-assessed clinical scores, including pain, symptoms, activities of daily living, sports activity, and quality of life, were improved significantly at three years after surgery. Defect filling was confirmed using second-look arthroscopy at 72 weeks. Significantly improved MRI scores were observed from 12 to 144 weeks postoperatively. Histological examination of biopsy specimens obtained at 72 weeks after implantation revealed an extracellular matrix rich in glycosaminoglycan and type II collagen in the reparative tissue. Histological assessment yielded a mean overall International Cartilage Regeneration & Joint Preservation Society II score of 69.1 points (SD 10.4; 50 to 80). Conclusion. This study provides evidence supporting the safety of acellular UPAL gel implantation in facilitating cartilage repair. Despite being a single-arm study, it demonstrated the efficacy of UPAL gel implantation, suggesting it is an easy-to-use, one-step method of cartilage tissue repair circumventing the need to harvest donor cells. Cite this article: Bone Joint J 2023;105-B(8):880–887


The Bone & Joint Journal
Vol. 99-B, Issue 7 | Pages 904 - 911
1 Jul 2017
Wall PDH Sprowson† AP Parsons NR Parsons H Achten J Balasubramanian S Thompson P Costa ML

Aims. The aim of this study was to compare the effectiveness of a femoral nerve block and a periarticular infiltration in the management of early post-operative pain after total knee arthroplasty (TKA). Patients and Methods. A pragmatic, single centre, two arm parallel group, patient blinded, randomised controlled trial was undertaken. All patients due for TKA were eligible. Exclusion criteria included contraindications to the medications involved in the study and patients with a neurological abnormality of the lower limb. Patients received either a femoral nerve block with 75 mg of 0.25% levobupivacaine hydrochloride around the nerve, or periarticular infiltration with 150 mg of 0.25% levobupivacaine hydrochloride, 10 mg morphine sulphate, 30 mg ketorolac trometamol and 0.25 mg of adrenaline all diluted with 0.9% saline to make a volume of 150 ml. Results. A total of 264 patients were recruited and data from 230 (88%) were available for the primary analysis. Intention-to-treat analysis of the primary outcome measure of a visual analogue score for pain on the first post-operative day, prior to physiotherapy, was similar in both groups. The mean difference was -0.7 (95% confidence interval (CI) -5.9 to 4.5; p = 0.834). The periarticular group used less morphine in the first post-operative day compared with the femoral nerve block group (74%, 95% CI 55 to 99). The femoral nerve block group reported 39 adverse events, of which 27 were serious, in 31 patients and the periarticular group reported 51 adverse events, of which 38 were serious, in 42 patients up to six weeks post-operatively. None of the adverse events were directly attributed to either of the interventions under investigation. Conclusion . Periarticular infiltration is a viable and safe alternative to femoral nerve block for the early post-operative relief of pain following TKA. Cite this article: Bone Joint J 2017;99-B:904–11


The Bone & Joint Journal
Vol. 106-B, Issue 9 | Pages 907 - 915
1 Sep 2024
Ross M Zhou Y English M Sharplin P Hirner M

Aims. Knee osteoarthritis (OA) is characterized by a chronic inflammatory process involving multiple cytokine pathways, leading to articular cartilage degeneration. Intra-articular therapies using pharmaceutical or autologous anti-inflammatory factors offer potential non-surgical treatment options. Autologous protein solution (APS) is one such product that uses the patient’s blood to produce a concentrate of cells and anti-inflammatory cytokines. This study evaluated the effect of a specific APS intra-articular injection (nSTRIDE) on patient-reported outcome measures compared to saline in moderate knee OA. Methods. A parallel, double-blinded, placebo-controlled randomized controlled trial was conducted, where patients with unilateral moderate knee OA (Kellgren-Lawrence grade 2 or 3) received either nSTRIDE or saline (placebo) injection to their symptomatic knee. The primary outcome was the difference in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score at 12 months post-intervention. Secondary outcomes included WOMAC component scores, Knee injury and Osteoarthritis Outcome Score (KOOS), and visual analogue scale (VAS) scores at all follow-up timepoints (three, six, and 12 months). Results. A total of 40 patients were analyzed (21 nSTRIDE; 19 saline) in the study. No significant difference was found between nSTRIDE and saline groups for WOMAC total score at 12 months (mean difference -10.4 (95% CI -24.4 to 3.6; p = 0.141). There were no significant differences in WOMAC or KOOS scores across all timepoints. VAS scores favoured the saline group for both rest and worst pain scales at 12 months post-injection (mean difference (worst) 12 months 21.5 (95% CI 6.2 to 36.8; p = 0.008); mean difference (rest) 12 months 17.8 (95% CI 2.2 to 33.4; p = 0.026)). There were no adverse events recorded in either study group. Conclusion. Our study demonstrates no significant differences between nSTRIDE and saline groups in KOOS and WOMAC scores over time. Notably, APS injection resulted in significantly worse pain symptoms at 12 months compared to saline injection. Cite this article: Bone Joint J 2024;106-B(9):907–915


Bone & Joint Research
Vol. 10, Issue 6 | Pages 363 - 369
1 Jun 2021
MacDonald DRW Neilly DW Elliott KE Johnstone AJ

Aims. Tourniquets have potential adverse effects including postoperative thigh pain, likely caused by their ischaemic and possible compressive effects. The aims of this preliminary study were to determine if it is possible to directly measure intramuscular pH in human subjects over time, and to measure the intramuscular pH changes resulting from tourniquet ischaemia in patients undergoing knee arthroscopy. Methods. For patients undergoing short knee arthroscopic procedures, a sterile calibrated pH probe was inserted into the anterior fascial compartment of the leg after skin preparation, but before tourniquet inflation. The limb was elevated for three minutes prior to tourniquet inflation to 250 mmHg or 300 mmHg. Intramuscular pH was recorded at one-second intervals throughout the procedure and for 20 minutes following tourniquet deflation. Probe-related adverse events were recorded. Results. A total of 27 patients were recruited to the study. Mean tourniquet time was 21 minutes (10 to 56). Tourniquet pressure was 300 mmHg for 21 patients and 250 mmHg for six patients. Mean muscle pH prior to tourniquet inflation was 6.80. Muscle pH decreased upon tourniquet inflation, with a steeper fall in the first ten minutes than for the rest of the procedure. Change in muscle pH was significant after five minutes of tourniquet ischaemia (p < 0.001). Mean muscle pH prior to tourniquet release was 6.58 and recovered to 6.75 within 20 minutes following release. No probe related adverse events were recorded. Conclusion. It is possible to directly measure skeletal muscle pH in human subjects over time. Tourniquet ischaemia results in a decrease in human skeletal muscle pH over time during short procedures. Cite this article: Bone Joint Res 2021;10(6):363–369


The Bone & Joint Journal
Vol. 106-B, Issue 9 | Pages 916 - 923
1 Sep 2024
Fricka KB Wilson EJ Strait AV Ho H Hopper, Jr RH Hamilton WG Sershon RA

Aims. The optimal bearing surface design for medial unicompartmental knee arthroplasty (UKA) remains controversial. The aim of this study was to compare outcomes of fixed-bearing (FB) and mobile-bearing (MB) UKAs from a single high-volume institution. Methods. Prospectively collected data were reviewed for all primary cemented medial UKAs performed by seven surgeons from January 2006 to December 2022. A total of 2,999 UKAs were identified, including 2,315 FB and 684 MB cases. The primary outcome measure was implant survival. Secondary outcomes included 90-day and cumulative complications, reoperations, component revisions, conversion arthroplasties, range of motion, and patient-reported outcome measures. Overall mean age at surgery was 65.7 years (32.9 to 94.3), 53.1% (1,593/2,999) of UKAs were implanted in female patients, and demographics between groups were similar (p > 0.05). The mean follow-up for all UKAs was 3.7 years (0.0 to 15.6). Results. Using revision for any reason as an endpoint, five-year survival for FB UKAs was 97.2% (95% CI 96.4 to 98.1) compared to 96.0% for MB (95% CI 94.1 to 97.9; p = 0.008). The FB group experienced fewer component revisions (14/2,315, 0.6% vs 12/684, 1.8%; p < 0.001) and conversion arthroplasties (38/2315, 1.6% vs 24/684, 3.5%; p < 0.001). A greater number of MB UKAs underwent revision due to osteoarthritis progression (FB = 21/2,315, 0.9% vs MB = 16/684, 2.3%; p = 0.003). In the MB group, 12 (1.8%) subjects experienced bearing dislocations which required revision surgery. There were 15 early periprosthetic tibia fractures (0.6%) in the FB group compared to 0 for MB (p = 0.035). Conclusion. In similar patient populations, FB UKAs demonstrated slightly higher survival than a commonly used MB design. Adverse event profiles differed by bearing type, with an increased risk of bearing dislocation and OA progression with MB designs, and early periprosthetic tibia fractures for FB designs. Cite this article: Bone Joint J 2024;106-B(9):916–923


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_13 | Pages 54 - 54
7 Aug 2023
Kraus M Bingham J Kekic A Erickson C Grilli C Seamans D Upjohn D Hentz J Clarke H Spangehl M
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Abstract. Introduction. Adverse reactions to pain medication and pain can delay discharge after outpatient knee arthroplasty (TKA). Pharmacogenomics is an emerging tool that might help reduce adverse events by tailoring medication use based on known genetic variations in the CYP genes determining drug metabolism. This study was undertaken to evaluate whether pre-operative pharmacogenomic testing could optimize peri-operative pain management in patients undergoing total knee arthroplasty (TKA). Methods. This prospective, randomized study was performed in adults undergoing primary TKA. Patients in the experimental group underwent pre-operative pharmacogenomic evaluation and medication adjustments. Medications were not optimized for control patients. The Overall Benefit of Analgesic Score (OBAS) at 24 hours post-op was the primary outcome. Postoperative pain scores (VAS scale), total opioid use, time in recovery, and time to discharge were also compared. Results. 76 patients enrolled. 93% of patients had a poor-intermediate phenotype for at least one of four CYP genes. OBAS did not differ significantly between the two groups (4.2 control vs. 4.7 experimental; 95% CI −1.1 to 2.1) and was below the minimum clinically important difference of 2.0 points. Furthermore, there were no differences in any OBAS subscale including pain, satisfaction, or nausea. There were no differences in time in the recovery area or to discharge from hospital, or narcotic use. Conclusions. Despite many patients having a poor-intermediate phenotype for a CYP gene, pharmacogenomic testing prior to TKA and medication adjustment did not improve anesthesia or pain management outcomes, time to discharge or mean total opioid use after surgery


The Bone & Joint Journal
Vol. 103-B, Issue 5 | Pages 830 - 839
1 May 2021
Ahmed I Chawla A Underwood M Price AJ Metcalfe A Hutchinson CE Warwick J Seers K Parsons H Wall PDH

Aims. Many surgeons choose to perform total knee arthroplasty (TKA) surgery with the aid of a tourniquet. A tourniquet is a device that fits around the leg and restricts blood flow to the limb. There is a need to understand whether tourniquets are safe, and if they benefit, or harm, patients. The aim of this study was to determine the benefits and harms of tourniquet use in TKA surgery. Methods. We searched MEDLINE, EMBASE, Cochrane Central Register of Controlled trials, and trial registries up to 26 March 2020. We included randomized controlled trials (RCTs), comparing TKA with a tourniquet versus without a tourniquet. Outcomes included: pain, function, serious adverse events (SAEs), blood loss, implant stability, duration of surgery, and length of hospital stay. Results. We included 41 RCTs with 2,819 participants. SAEs were significantly more common in the tourniquet group (53/901 vs 26/898, tourniquet vs no tourniquet respectively) (risk ratio 1.73 (95% confidence interval (CI) 1.10 to 2.73). The mean pain score on the first postoperative day was 1.25 points higher (95% CI 0.32 to 2.19) in the tourniquet group. Overall blood loss did not differ between groups (mean difference 8.61 ml; 95% CI -83.76 to 100.97). The mean length of hospital stay was 0.34 days longer in the group that had surgery with a tourniquet (95% CI 0.03 to 0.64) and the mean duration of surgery was 3.7 minutes shorter (95% CI -5.53 to -1.87). Conclusion. TKA with a tourniquet is associated with an increased risk of SAEs, pain, and a marginally longer hospital stay. The only finding in favour of tourniquet use was a shorter time in theatre. The results make it difficult to justify the routine use of a tourniquet in TKA surgery. Cite this article: Bone Joint J 2021;103-B(5):830–839


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_7 | Pages 6 - 6
1 Jul 2022
Hamilton T Knight R Stokes J Rombach I Cooper C Davies L Dutton S Barker K Cook J Lamb S Murray D Poulton L Wang A Strickland L Duren BV Leal J Beard D Pandit H
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Abstract. Introduction. This multi-centre randomised controlled trial evaluated the clinical and cost effectiveness of liposomal bupivacaine for pain and recovery following knee replacement. Methodology. 533patients undergoing primary knee replacement were randomised to receive either liposomal bupivacaine (266mg) plus bupivacaine hydrochloride (100mg) or control (bupivacaine hydrochloride 100mg), administered at the surgical site. The co-primary outcomes were pain visual analogue score (VAS) area under the curve (AUC) 6 to 72hours and the Quality of Recovery 40 (QoR-40) score at 72hours. Results. Primary analysis found no difference in pain VAS AUC 6 to 72hours between liposomal bupivacaine and control (MD -21.5 (97.5% CI -46.8 to 3.8; p=0.057)), nor the QoR-40 at 72hours (MD 0.54, 97.5% CI -2.05 to 3.13, p=0.643). Analyses of pain VAS and QoR-40 scores on days 0, 1, 2 and 3 demonstrated only one significant difference, with the liposomal bupivacaine arm having lower pain scores the evening of surgery (day0; MD -0.54, 97.5% CI -1.07 to -0.02; p=0.021). No difference in cumulative opioid consumption or functional outcome at 6weeks, 6months or 1year was detected. Heath economic analysis found liposomal bupivacaine to be less effective in terms of QALYs as well as more costly. No difference in adverse events between arms was identified. Conclusion. This is the largest RCT evaluating the clinical and cost effectiveness of liposomal bupivacaine It found that compared to bupivacaine hydrochloride local infiltration of liposomal bupivacaine at the surgical site does not provide any clinical or cost benefit for knee replacement and therefore should not be routinely used


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_7 | Pages 32 - 32
1 Jul 2022
Belsey J Gregory R Paine E Faulkner J
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Abstract. Introduction. Cryocompression therapy after knee surgery is widely utilised for post-operative rehabilitation. Skin temperature should be reduced to 10–15°C to maximise the therapeutic benefits while avoiding risks of adverse events. Some cryocompression devices offer control over the temperature of the ice-water circulated through a cuff. The degree to which this corresponds to the achieved skin temperature during a treatment is unknown. Methods. 30 healthy participants volunteered for this prospective randomised crossover trial involving the use of a cryocompression device. Each underwent a 30-minute test in all of five conditions: A, B, C, D and Control. Conditions corresponded to device temperature settings of 6, 8, 10, 12°C and no ice-water circulation, respectively. Skin temperature was measured prior to the cuff being applied, then every 5 minutes during a test. Results. Groups A, B, C and D significantly reduced skin temperature relative to the Control condition (p<0.05). Mean baseline skin temperatures did not significantly differ between groups. Mean skin temperatures after 30 minutes were 13.2 ± 1.9°C (Group A), 14.4 ± 1.5°C (Group B), 16.3 ± 1.8°C (Group C), 18.3 ± 1.7°C (Group D), and 30.8 ± 2.3°C (Control). Conclusions. The cryocompression device successfully reduced the skin temperature to within the therapeutic range. However, temperature settings did not correspond to skin temperatures achieved. To optimise the therapeutic benefit of treatment with this device, the 6°C setting is recommended. (Note: these are preliminary results from on an ongoing study, comprising 72% of the final dataset. Full results will be presented at BASK 2022)


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_9 | Pages 60 - 60
1 Oct 2020
Yousef M Franklin P Zheng H Ayers DC
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Introduction. Patient satisfaction is an important outcome measure after total knee arthroplasty (TKA) and is the ultimate goal of surgery. However, patient satisfaction reflects a complex construct of the patient's personal expectations and preferences in addition to subjective evaluation of outcome after TKA. Multiple studies have found a patient dissatisfaction rate of approximately 20% at 1 year after TKA. The purpose of this study is to determine whether there is an association between a single-item validated TKA satisfaction score and patient-reported outcome measures (PROMs) at 3 time points (1, 2, and 5 years after TKA) and to determine if dissatisfaction rate after TKA varies over time. Methods. A multi-center, prospective cohort of 12,952 patients (8,078 patients were assessed at 1-year, 702 patients at 2-year, and 4,172 patients at 5-year) undergoing primary TKA were enrolled by 230 surgeons in 28 states between 2012–2015. Surgeons practices varied in size, reimbursement models, and geographic setting ensuring that the cohort included diverse patient populations and delivery models. Surgeons agreed to invite all TKA patients to participate and sporadic audits of surgical logs validated that all patients were invited and > 90% of patients were included. Demographic and clinical data [age, gender, body mass index (BMI), and modified Charlson co-morbidity index (CCI)] were collected. Patient-reported outcome measures (PROMs) were collected pre-op and post-op at 1, 2, and 5 years using an internet-based platform including the KOOS (total score, and pain, ADL, QoL sub scores), KOOS Jr, SF-36 (PCS and MCS). We used the single-item satisfaction scale which was tested and validated by the Swedish Knee Arthroplasty Registry. The patients' responses were made on 5-point Likert scale (very satisfied, somewhat satisfied, neutral, somewhat dissatisfied, very dissatisfied). Patients were classified into 2 categories: satisfied group for patients who answered satisfied or very satisfied and dissatisfied group for patients answered neutral, somewhat dissatisfied, or very dissatisfied. Univariate analysis of the difference between the satisfied and dissatisfied patients' groups was performed using Mann-Whitney U test for continuous variables and chi-square test for categorical variables. Logistic regression model was performed to study the correlation between the satisfaction and PROMs with 95% confidence interval. Results. Mean age was 66.6 years, 62.7% were female, and mean BMI was 31.6. The CCI was 0 in 55.1%, 1 in 22%, 2–5 in 12.6% and ≥ 6 in 10.3%. Cumulative revision rate was 1.29% at 2 years. The 30-day adverse events incidence was 2.5% while the 90-day adverse events incidence was 4.7%. The dissatisfaction rate was 18.1% at 1-year, 11.5% at 2-year, and 8.5% at 5-year (P<0.001, Chi-square). Dissatisfaction significantly affects younger patients (<55 years) (P=0.04, Chi-square) and patients with high Charlson comorbidity index >1 (P=0.001, Chi-square). Low post-operative KOOS Pain, KOOS ADL, KOOS total score, KOOS JR, SF-36 PCS, and SP-36 MCS scores were significantly associated with dissatisfaction (P<0.001). At 5 years follow-up, in patients with KOOS scores greater than 70, 1.3% of patients were dissatisfied; with KOOS 50–70, 16.3% were dissatisfied and when KOOS < 50, 62.2% are dissatisfied. Logistic regression showed significant correlation of satisfaction with postoperative KOOS pain, KOOS ADL, KOOS QoL, KOOS total score, KOOS JR, and SF-36 PCS (P< 0.001) at 1-year, 2-year, and at 5-year. The MCS was correlated with patient satisfaction only at 1-year (P< 0.001). Conclusion. The patient dissatisfaction rate 5 years after TKA is 8.1% in FORCE-TJR patients which is significantly lower than 18.1% at 1-year. Less improvement of PROM scores after TKA are significantly associated with patient dissatisfaction. Postoperative PROM scores are associated with patient satisfaction at 1-year, 2-years, and 5-years. When the 5-year post- op KOOS total score is >70, 98.7% of patients are satisfied and only 1.3% are dissatisfied. Patient satisfaction is an important outcome measure after TKA that can be determined by asking a single question. However, in order to understand why a patient is dissatisfied, KOOS scores (KOOS pain, KOOS ADL, KOOS QoL) that assess specific postoperative outcomes can assist in determining the reason for patient dissatisfaction after TKA


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXIX | Pages 11 - 11
1 Jul 2012
Jameson S Dowen D James P Reed M Deehan D
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Introduction. Unlike the NJR, no surgeon driven national database currently exists for ligament surgery in the UK and therefore information on outcome and adverse event is limited to case series. Methods. Prospectively collected Hospital episode statistics (HES) data for England was analysed so as to determine national rates of 90-day symptomatic deep venous thrombosis (DVT), pulmonary thromboembolism (PTE) rate, significant wound infection and 30-day readmission rates with cause following anterior cruciate ligament (ACL) reconstruction. This diagnostic and operative codes information is routinely collected on every patient admitted to hospital in England NHS. Results. All HES data between April 2008 and March 2010 was analysed for patients undergoing ACL reconstruction (13571 patients). 90-day DVT and PTE rates were 0.29% (40) and 0.20% (27) respectively. There were no deaths. 0.94% (127) had a wound complication recorded and 1.34% (182) were readmitted to an orthopaedic ward within 30 days. Conclusion. We are particularly interested in adverse event reporting from ACL surgery. Our knowledge of current UK ligament practice and outcome is based upon low uptake postal surveys and small number case series. We have been able to quantify the complication rate for thrombotic events, readmission rate and other adverse events following ACL surgery from a national database. Contrary to popular belief there is a real but small risk of PTE following ACL surgery. We believe this data strengthens the argument for a funded prospective UK ligament registry


The Bone & Joint Journal
Vol. 103-B, Issue 6 Supple A | Pages 18 - 22
1 Jun 2021
Omari AM Parcells BW Levine HB Seidenstein A Parvizi J Klein GR

Aims. The optimal management of an infrapopliteal deep venous thrombosis (IDVT) following total knee arthroplasty (TKA) remains unknown. The risk of DVT propagation and symptom progression must be balanced against potential haemorrhagic complications associated with administration of anticoagulation therapy. The current study reports on a cohort of patients diagnosed with IDVT following TKA who were treated with aspirin, followed closely for development of symptoms, and scanned with ultrasound to determine resolution of IDVT. Methods. Among a cohort of 5,078 patients undergoing TKA, 532 patients (695 TKAs, 12.6%) developed an IDVT between 1 January 2014 to 31 December 2019 at a single institution, as diagnosed using Doppler ultrasound at the first postoperative visit. Of the entire cohort of 532 patients with IDVT, 91.4% (486/532) were treated with aspirin (325 mg twice daily) and followed closely. Repeat lower limb ultrasound was performed four weeks later to evaluate the status of IDVT. Results. Follow-up Doppler ultrasound was performed on 459/486 (94.4%) patients and demonstrated resolution of IDVT in 445/459 cases (96.9%). Doppler diagnosed propagation of IDVT to the popliteal vein had occurred in 10/459 (2.2%) cases. One patient with an IDVT developed a pulmonary embolus six weeks postoperatively. Conclusion. The results of this study demonstrate a low rate of IDVT propagation in patients managed with aspirin. Additionally, no significant bleeding episodes, wound-related complications, or other adverse events were noted from aspirin therapy. Cite this article: Bone Joint J 2021;103-B(6 Supple A):18–22


The Bone & Joint Journal
Vol. 101-B, Issue 10 | Pages 1238 - 1247
1 Oct 2019
Soreide E Denbeigh JM Lewallen EA Thaler R Xu W Berglund L Yao JJ Martinez A Nordsletten L van Wijnen AJ Kakar S

Aims. Options for the treatment of intra-articular ligament injuries are limited, and insufficient ligament reconstruction can cause painful joint instability, loss of function, and progressive development of degenerative arthritis. This study aimed to assess the capability of a biologically enhanced matrix material for ligament reconstruction to withstand tensile forces within the joint and enhance ligament regeneration needed to regain joint function. Materials and Methods. A total of 18 New Zealand rabbits underwent bilateral anterior cruciate ligament reconstruction by autograft, FiberTape, or FiberTape-augmented autograft. Primary outcomes were biomechanical assessment (n = 17), microCT (µCT) assessment (n = 12), histological evaluation (n = 12), and quantitative polymerase chain reaction (qPCR) analysis (n = 6). Results. At eight weeks, FiberTape alone or FiberTape-augmented autograft demonstrated increased biomechanical stability compared with autograft regarding ultimate load to failure (p = 0.035), elongation (p = 0.006), and energy absorption (p = 0.022). FiberTape-grafted samples also demonstrated increased bone mineral density in the bone tunnel (p = 0.039). Histological evaluation showed integration of all grafts in the bone tunnels by new bone formation, and limited signs of inflammation overall. A lack of prolonged inflammation in all samples was confirmed by quantification of inflammation biomarkers. However, no regeneration of ligament-like tissue was observed along the suture tape materials. Except for one autograft failure, no adverse events were detected. Conclusion. Our results indicate that FiberTape increases the biomechanical performance of intra-articular ligament reconstructions in a verified rabbit model at eight weeks. Within this period, FiberTape did not adversely affect bone tunnel healing or invoke a prolonged elevation in inflammation. Cite this article: Bone Joint J 2019;101-B:1238–1247


Bone & Joint Research
Vol. 9, Issue 6 | Pages 322 - 332
1 Jun 2020
Zhao H Yeersheng R Kang X Xia Y Kang P Wang W

Aims. The aim of this study was to examine whether tourniquet use can improve perioperative blood loss, early function recovery, and pain after primary total knee arthroplasty (TKA) in the setting of multiple-dose intravenous tranexamic acid. Methods. This was a prospective, randomized clinical trial including 180 patients undergoing TKA with multiple doses of intravenous tranexamic acid. One group was treated with a tourniquet during the entire procedure, the second group received a tourniquet during cementing, and the third group did not receive a tourniquet. All patients received the same protocol of intravenous tranexamic acid (20 mg/kg) before skin incision, and three and six hours later (10 mg/kg). The primary outcome measure was perioperative blood loss. Secondary outcome measures were creatine kinase (CK), CRP, interleukin-6 (IL-6), visual analogue scale (VAS) pain score, limb swelling ratio, quadriceps strength, straight leg raising, range of motion (ROM), American Knee Society Score (KSS), and adverse events. Results. The mean total blood loss was lowest in the no-tourniquet group at 867.32 ml (SD 201.11), increased in the limited-tourniquet group at 1024.35 ml (SD 176.35), and was highest in the tourniquet group at 1,213.00 ml (SD 211.48). The hidden blood loss was lowest in the no-tourniquet group (both p < 0.001). There was less mean intraoperative blood loss in the tourniquet group (77.48 ml (SD 24.82)) than in the limited-tourniquet group (137.04 ml (SD 26.96)) and the no-tourniquet group (212.99 ml (SD 56.35); both p < 0.001). Patients in the tourniquet group showed significantly higher levels of muscle damage and inflammation biomarkers such as CK, CRP, and IL-6 than the other two groups (p < 0.05). Outcomes for VAS pain scores, limb swelling ratio, quadriceps strength, straight leg raising, ROM, and KSS were significantly better in the no-tourniquet group at three weeks postoperatively (p < 0.05), but there were no significant differences at three months. No significant differences were observed among the three groups with respect to transfusion rate, thrombotic events, or the length of hospital stay. Conclusion. Patients who underwent TKA with multiple doses of intravenous tranexamic acid but without a tourniquet presented lower total blood loss and hidden blood loss, and they showed less postoperative inflammation reaction, less muscle damage, lower VAS pain score, and better early knee function. Our results argue for not using a tourniquet during TKA. Cite this article: Bone Joint Res 2020;9(6):322–332


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_9 | Pages 41 - 41
1 Oct 2020
Pandit HG Blyth M Maheshwari R McDonnell S Frappin G Hagen M Maybaum N Moreira S Seefried L
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Introduction. Topical diclofenac has proven efficacy and safety in the management of osteoarthritic pain. Its therapeutic efficacy is dependent on its ability to deliver pharmacodynamically active concentrations to the underlying tissues in the affected joint. However, the disposition of topical diclofenac is not fully characterized, and no studies have been performed using diclofenac diethylamine 2.32% gel. Methods. This study investigated the penetration of topical diclofenac into knee synovial tissue and fluid and evaluated relative exposure in the knee versus plasma. In this phase 1, double-blind, placebo-controlled steady-state multicenter pharmacokinetic study, patients scheduled for arthroplasty to treat knee OA were randomly assigned 2:1 to 4 g diclofenac/placebo gel, applied to the affected knee every 12 hours for 7 days pre-surgery. Diclofenac concentrations were measured in synovial tissue, fluid, and plasma ≥12 hours after last application. Adverse events (AEs) were evaluated. Diclofenac concentrations were assayed by validated high-performance liquid chromatography and tandem mass spectrometry. Results. Samples were obtained from 45 (diclofenac n=29; placebo n=16) of 47 patients enrolled. Mean (SD) age was 71.2 (7.9) years with 52.2% women and mean (SD) BMI 30.7 (4.8) kg/m. 2. All diclofenac-treated participants had measurable diclofenac concentrations in synovial tissue (mean [95% CI]) 1.57 [1.12, 2.20] ng/g) and fluid 2.27 [1.87, 2.76] ng/mL ≥12 hours after the last dose. The mean (95% CI) ratio of diclofenac in synovial tissue:plasma was 0.32 (0.23, 0.45) and in synovial fluid:plasma was 0.46 (0.34, 0.54). AEs were similar for diclofenac (55.2%) and placebo (58.8%); none were treatment related. No correlation (r=−0.003) between BMI and synovial fluid concentration, and weak positive correlation (r=0.315) between BMI and synovial tissue concentration were observed. Conclusions. Topical diclofenac diethylamine 2.32% gel penetrated the knee and remained detectable at the end of the final 12-hour dosing cycle. BMI had no impact on diclofenac's penetration into the knee


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_IX | Pages 47 - 47
1 Mar 2012
Almqvist K Vanlauwe J Saris D Victor J Verdonk P Bellemans J Verdonk R
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Introduction. Autologous chondrocyte implantation presents a viable alternative to microfracture in the repair of damaged articular cartilage of the knee; however, outcomes for patellar lesions have been less encouraging. ChondroCelect (CC) is an innovative, advanced cell therapy product consisting of autologous cartilage cells expanded ex vivo through a highly controlled and consistent manufacturing process. Purpose. To assess the effect of CC in the treatment of patellofemoral lesions, for which standard treatment options had failed and/or no other treatment options were considered feasible. Methods. CC was administered to 61 patients with patellar lesions (predominantly secured with a biological membrane; mean lesion size: 3.6 cm. 2. ; aged 32.4 years). Efficacy was assessed with validated scales of Clinical Global Impression for Improvement (CGI-I) and Therapeutic Effect (CGI-E) and stratified by the postoperative follow-up period (<18 months vs >18 months). Results. CC resulted in therapeutic and clinical improvement in 87% of patients. Long-term follow-up showed a modest shift towards worse CGI-I and CGI-E scores, with the ‘very much improved’ subgroup (CGI-I) during the first 18 months (38.5%) moderately reduced after 18 months (25.0%); however, the proportion of improved patients remained consistent. The most commonly reported adverse events (knee pain [23%], joint crepitation [13.1%], joint range of motion decreased [13.1%], arthrofibrosis [8.2%] and tendon disorder [8.2%]) were reported at incidences higher than those associated with femoral condyle and trochlea lesions. There were no reports of cartilage hypertrophy. Conclusion. CC was effective in the treatment of patellofemoral lesions, with results comparable to outcomes for femoral condyle and trochlear lesions. The higher incidence of some adverse events suggests that the risk-benefit balance of CC varies with lesion location. However, there were no major safety concerns and the safety profile of CC was greatly enhanced by absence of cartilage hypertrophy, demonstrating that collagen membranes can eliminate periosteum-associated events


The Bone & Joint Journal
Vol. 98-B, Issue 7 | Pages 934 - 938
1 Jul 2016
Lamplot JD Brophy RH

Aims. Patients with osteoarthritis of the knee commonly have degenerative meniscal tears. Arthroscopic meniscectomy is frequently performed, although the benefits are debatable. Recent studies have concluded that there is no role for arthroscopic washout in osteoarthritis of the knee. Our aim was to perform a systematic review to assess the evidence for the efficacy of arthroscopic meniscectomy in patients with meniscal tears and degenerative changes in the knee. Patients and Methods. A literature search was performed, using the PubMed/MEDLINE database, for relevant articles published between 1975 and 2015. A total of six studies, including five randomised controlled trials and one cross-sectional study of a prospective cohort, met the inclusion criteria. Relevant information including study design, operations, the characteristics of the patients, outcomes, adverse events and further operations were extracted. Results. The degree of osteoarthritis in the patients who were included and the rate of cross over from one form of treatment to another varied in the studies. Two randomised controlled trials showed a benefit of arthroscopic surgery in patients with limited degenerative joint disease, compared with conservative treatment. One cross-sectional study showed that patients with less severe degenerative changes had better outcomes. Conclusion. Patients with symptomatic meniscal tears and degenerative changes in the knee can benefit from arthroscopic meniscectomy, particularly if the osteoarthritis is mild. A trial of conservative management may be effective and should be considered, especially in patients with moderate osteoarthritis. Cite this article: Bone Joint J 2016;98-B:934–8