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The Journal of Bone & Joint Surgery British Volume
Vol. 93-B, Issue 6 | Pages 720 - 721
1 Jun 2011
Rangan A Maffulli N

Multicentre clinical trials in trauma care are gaining prominence as a means of generating good-quality evidence to inform and influence clinical practice. We believe multicentre trials have an important role to play in supporting evidence-based practice, and further investment in such trials is justified.


The Journal of Bone & Joint Surgery British Volume
Vol. 71-B, Issue 4 | Pages 681 - 684
1 Aug 1989
Lilius G Laasonen E Myllynen P Harilainen A Gronlund G

A group of 109 patients with unilateral low back pain for over three months were randomised to receive one of three types of injection treatment: cortisone and local anaesthetic injected into two facet joints (28), the same mixture around two facet joints (39), or physiological saline into two facet joints (42). The effect of the treatment was evaluated in relation to work attendance, pain, disability and movements of the lumbar spine. Patients were examined one hour and two and six weeks after treatment and also completed a questionnaire after three months. A significant improvement was observed in work attendance, pain and disability scores, but this was independent of the treatment given and movements of the lumbar spine were not improved. Of the 70 patients with initial pain relief after injection, 36% reported persisting benefit at the three month follow-up, independent of the mode of treatment given. We conclude that facet joint injection is a non-specific method of treatment and the good results depend on a tendency to spontaneous regression and to the psychosocial aspects of back pain.


The Journal of Bone & Joint Surgery British Volume
Vol. 77-B, Issue 6 | Pages 870 - 874
1 Nov 1995
Koo K Kim R Ko G Song H Jeong S Cho S

We performed a randomised trial on 37 hips (33 patients) with early-stage osteonecrosis (ON). After the initial clinical evaluation, including plain radiography and MRI, 18 hips were randomly assigned to a core-decompression group and 19 to a conservatively-treated group. All the patients were regularly followed up by clinical evaluation, plain radiography and MRI at intervals of three months. Hip pain was relieved in nine out of ten initially symptomatic hips in the core-decompression group but persisted in three out of four initially painful hips in the conservatively-treated group at the second assessment (p < 0.05). At a minimum follow-up of 24 months, 14 of the 18 core-decompressed hips (78%) and 15 of the 19 non-operated hips (79%) developed collapse of the femoral head. By survival analysis, there was no significant difference in the time to collapse between the two groups (log-rank test p = 0.79). Core decompression may be effective tin symptomatic relief, but is of no greater value than conservative management in preventing collapse in early osteonecrosis of the femoral head.


Bone & Joint Open
Vol. 1, Issue 6 | Pages 214 - 221
8 Jun 2020
Achten J Knight R Dutton SJ Costa ML Mason J Dritsaki M Appelbe D Messahel S Roland D Widnall J Perry DC

Aims

Torus fractures are the most common childhood fracture, accounting for 500,000 UK emergency attendances per year. UK treatment varies widely due to lack of scientific evidence. This is the protocol for a randomized controlled equivalence trial of ‘the offer of a soft bandage and immediate discharge’ versus ‘rigid immobilization and follow-up as per the protocol of the treating centre’ in the treatment of torus fractures .

Methods

Children aged four to 15-years-old inclusive who have sustained a torus/buckle fracture of the distal radius with/without an injury to the ulna are eligible to take part. Baseline pain as measured by the Wong Baker FACES pain scale, function using the Patient-Reported Outcomes Measurement Information System (PROMIS) upper limb, and quality of life (QoL) assessed with the EuroQol EQ-5D-Y will be collected. Each patient will be randomly allocated (1:1, stratified by centre and age group (four to seven years and ≥ eight years) to either a regimen of the offer of a soft bandage and immediate discharge or rigid immobilization and follow-up as per the protocol of the treating centre.


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_13 | Pages 4 - 4
17 Jun 2024
Carter T Oliver W Bell K Graham C Duckworth A White T Heinz N
Full Access

Introduction. Unstable ankle fractures are routinely managed operatively. Due to soft-tissue and implant related complications, there has been recent literature reporting on the non-operative management of well-reduced medial malleolus fractures following fibular stabilisation, but with limited evidence supporting routine application. This trial assessed the superiority of internal fixation of well-reduced (displacement ≤2mm) medial malleolus fractures compared with non-fixation following fibular stabilisation. Methods and participants. Superiority, pragmatic, parallel, prospective randomised clinical trial conducted over a four year period. A total of 154 adult patients with a bi- or trimalleolar fractures were recruited from a single centre. Open injuries and vertical medial malleolar fractures were excluded. Following fibular stabilisation, patients were randomised intra-operatively on a 1:1 basis to fixation or non-fixation after satisfactory fluoroscopic fracture reduction was confirmed. The primary outcome was the Olerud Molander Ankle Score (OMAS) at one-year post-randomisation. Complications and radiographic outcomes were documented over the follow-up period. Results. Among 154 participants (mean age, 56.5 years; 119 women [77%]), 144 [94%] completed the trial. At one-year the median OMAS was 80 (IQR, 60–90) in the fixation group compared with 72.5 (IQR, 55–90) in the non-fixation group (p=0.17). Complication rates were comparable. Significantly more patients in the non-fixation group developed a radiographic non-union (20% vs 0%; p<0.001), with the majority (n=8/13) clinically asymptomatic and one patient required surgical re-intervention for this. Fracture type and reduction quality appeared to influence fracture union and patient outcome. Conclusions. In this randomised clinical trial comparing internal fixation of well-reduced medial malleolus fractures with non-fixation, following fibular stabilisation, fixation was not superior according to the primary outcome. However, 1 in 5 patients following non-fixation developed a radiographic non-union and whilst the re-intervention rate to manage this was low, the future implications require surveillance. These results may support selective non-fixation of anatomically reduced medial malleolus fractures


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_13 | Pages 11 - 11
17 Jun 2024
Lewis T Ferreira G Nunes G Ray R
Full Access

Background. Infiltration is considered the first treatment option for symptomatic Morton's neuroma and can be performed with various medications. The aim of this study was to compare the effects of hyaluronic acid infiltration versus corticosteroid injection in the treatment of Morton's neuroma. Methods. A randomised clinical trial was conducted with 46 patients (50 feet) diagnosed with Morton's neuroma. After randomisation, the control group (CG) received three injections (one per week) of triamcinolone (Triancil®) guided by ultrasound, while the study group (SG) received three applications of hyaluronic acid (Osteonil Plus®). Patients were followed up for six months after the intervention. The primary outcome measure used was the Visual Pain Analog Scale (VAS). Secondary endpoints included patient-reported outcome measures using the American Orthopaedic Foot & Ankle Society (AOFAS) score and complications. Results. Both groups showed significant improvement in VAS and AOFAS scores (p < 0.001). The CG showed greater improvement than the SG in the VAS (p < 0.05) and AOFAS (p < 0.001) variables. Four patients in the CG experienced skin hypochromia at the injection site, while there were no complications in the SG. Conclusion. Ultrasound-guided hyaluronic acid infiltration in Morton's Neuroma proved to be safe, showing improvement in pain and function after six months of follow-up, without major complications, but with a significantly lower improvement when compared to corticosteroid injection. Taking into account cost implications and the potential for longer lasting improvement from viscosupplementation further medium- and long-term studies are needed


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_II | Pages 245 - 245
1 May 2009
Dulai S Beauchamp R Mulpuri K Slobogean BL
Full Access

The promotion and practice of evidence-based medicine necessitates a critical evaluation of medical literature including the “gold standard” of randomised clinical trials. Recent studies have examined the quality of randomised clinical trials in various surgical specialties, but no study has focused on pediatric orthopedics. The purpose of this study was to assess and describe the quality of randomised clinical trials published in the last ten years in journals with high clinical impact in pediatric orthopaedics. All of the randomised clinical trials in pediatric orthopedics published in five well-recognised journals between 1995–2005 were reviewed using the Detsky Quality Assessment Scale. The mean percentage score on the Detsky Scale was 53% (95% CI: 46%–60%). Only seven (19%) of the articles satisfied the threshold for a satisfactory level of methodologic quality (Detsky > 75%). The majority of randomised clinical trials in pediatric orthopedics that are published in well-recognised, peer-reviewed journals demonstrate substantial deficiencies in methodologic quality. Particular areas of weakness include inadequate rigor and reporting of randomization methods, use of inappropriate or poorly-described outcome measures, inadequate description of inclusion and exclusion criteria and inappropriate statistical analysis. Further efforts are necessary to improve the conduct and reporting of clinical trials in this field in order to avoid inadvertent misinformation of the clinical community


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_8 | Pages 101 - 101
1 May 2014
MacDonald S
Full Access

There has been ongoing debate for many years on the relative merits of routine tourniquet use while performing a total knee replacement. Interestingly there have been many retrospective reviews and opinion articles on the topic, but little in the way of well powered prospective randomised clinical trials. Those that dislike the premise of routine tourniquet use usually cite a list of either very rare complications, or theoretical concerns (nerve damage, muscle function, wound healing issues). Like most debate topics however, the issue is usually a shade of grey, rather than black and white, if the pro/con arguments are evaluated individually. There can be little debate that intraoperative blood loss is less with the use of a tourniquet. This has been demonstrated in multiple studies and is clearly intuitively obvious. Interestingly the overall blood loss (intraop + postop) may however be the same regardless of tourniquet use. Having a dry operative field however is important in achieving adequate cement fixation, and if tourniquet use is not employed, an alternative should be. There is an overwhelming body of literature that supports the understanding that increased OR time directly correlates to increased infection rates in total joint arthroplasty. Proponents of not using a tourniquet will often have alternates to achieving a dry operative field that clearly add time to the procedure – meticulous hemostasis, air delivery systems, etc. This increased OR time may come at the cost of increased infection risk. There is clearly a need for well-designed randomised clinical trials evaluating the practice of routine tourniquet use in TKA. Any trial done however must look critically at factors such as OR time, costs of alternatives, and potential long-term outcome effects


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_7 | Pages 88 - 88
1 Apr 2017
Barrack R
Full Access

Resurfacing the patella is performed the majority of the time in the United States and in many regions it is considered standard practice. In many countries, however, the patella is left un-resurfaced an equal amount of the time or even rarely ever resurfaced. Patella resurfacing is not a simple or benign procedure. There are numerous negative sequelae of resurfacing including loosening, fragmentation, avascular necrosis, lateral facet pain, stress fracture, acute fracture, late fracture, and restricted motion. In a study by Berend, Ritter, et al, failures of the patella component were reported 4.2% of the time at an average of only 2.6 years. A study was undertaken at Washington University in recent years to determine rather more clinical problems were observed following total knee replacement with or without patella resurfacing. Records were maintained on all problem total knees cases with well localised anterior knee pain. The referral area for this clinic is St. Louis which is among the largest American cities, with the highest percentage of total knees that are performed without patella resurfacing. During 4 years of referrals of total knee patients with anterior knee pain, 47 cases were identified of which 36 had a resurfaced patella and 11 had a non-resurfaced patella. Eight of 36 resurfaced patellae underwent surgery while only 2 of 11 non-resurfaced patellae underwent subsequent surgery. More than 3 times as many painful total knees that were referred for evaluation had already had their patella resurfaced. In spite of the fact that approximately equal number of total knees were performed in this area without patella resurfacing, far more patients presented to clinic with painful total knee in which the patella had been resurfaced. The numerous pathologies requiring a treatment following patella resurfacing included patella loosening, fragmentation of the patella, avascular necrosis patella, late stress fracture, lateral facet pain, oblique resurfacing, and too thick of a patellar composite. In a large multi-center randomised clinical trial at 5 years from the United Kingdom in over 1700 knees from 34 centers and 116 surgeons, there was no difference in the Oxford Score, SF-12, EQ-5D, or need for further surgery or complications. The authors concluded, “We see no difference in any score, if there is a difference, it is too small to be of any clinical significance”. In a prospective of randomised clinical trial performed at Tulane University over 20 years ago, no differences were observed in knee score, a functional patella questionnaire, or the incidence of anterior knee pain between resurfaced and un-resurfaced patellae at time intervals of 2–4 years, 5–7 years, or greater than 10 years. Beyond 10 years the knee scores of total knee patients with a resurfaced patella had declined significantly greater than those with a non-resurfaced patella. There are numerous advantages of not resurfacing the patella including less surgical time, less expense, a lower risk of “major” complications (especially late complications), and if symptoms develop in an un-resurfaced patella, it is an easier salvage situation with more options available. A small percentage of total knee patients will be symptomatic whether or not their patella is resurfaced. Not resurfacing the patella retains more options and has fewer complications. The major determinant of clinical result and the presence of anterior knee pain after knee replacement is surgical technique and component design not whether or not the patella is resurfaced. Patella resurfacing is occasionally necessary for patients with inflammatory arthritis, a deformed or maltracking patella, or symptoms and pathology that are virtually restricted to the patellofemoral joint. For the vast majority of patients, however, patella resurfacing is not necessary


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_12 | Pages 26 - 26
1 Jul 2014
MacDonald S
Full Access

There has been ongoing debate for many years on the relative merits of routine tourniquet use while performing a total knee replacement. Interestingly there have been many retrospective reviews and opinion articles on the topic, but little in the way of well powered prospective randomised clinical trials. Those that dislike the premise of routine tourniquet use usually cite a list of either very rare complications, or theoretical concerns (nerve damage, muscle function, wound healing issues). Like most debate topics, however, the issue is usually a shade of grey, rather than black and white, if the pro/con arguments are evaluated individually. 1. Blood Loss. There can be little debate that intra-operative blood loss is less with the use of a tourniquet. This has been demonstrated in multiple studies and is clearly intuitively obvious. Interestingly the overall blood loss (intra-op + post-op) may, however, be the same regardless of tourniquet use. Having a dry operative field, however, is important in achieving adequate cement fixation, and if tourniquet use is not employed, an alternative should be. 2. OR time. There is an overwhelming body of literature that supports the understanding that increased OR time directly correlates to increased infection rates in total joint arthroplasty. Proponents of not using a tourniquet will often have alternates to achieving a dry operative field that clearly add time to the procedure – meticulous hemostasis, air delivery systems, etc. This increased OR time may come at the cost of increased infection risk. There is clearly a need for well-designed randomised clinical trials evaluating the practice of routine tourniquet use in TKA. Any trial done, however, must look critically at factors such as OR time, costs of alternatives, and potential long-term outcome effects


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_17 | Pages 53 - 53
1 Nov 2016
Barrack R
Full Access

Resurfacing the patella is performed the majority of the time in the US and in many regions it is considered standard practice. In many countries, however, the patella is left unresurfaced an equal amount of the time or even rarely ever resurfaced. Patella resurfacing is not a simple or benign procedure. There are numerous negative sequelae of resurfacing including loosening, fragmentation, avascular necrosis, lateral facet pain, stress fracture, acute fracture, late fracture, and restricted motion. In a study by Berend, Ritter, et al, failures of the patella component were reported 4.2% of the time at an average of only 2.6 years. A study was undertaken at Washington University in recent years to determine whether more clinical problems were observed following total knee replacement with or without patella resurfacing. Records were maintained on all problem total knees cases with well localised anterior knee pain. The referral area for this clinic is St. Louis which is among the largest American cities, with the highest percentage of total knees that are performed without patella resurfacing. During 4 years of referrals of total knee patients with anterior knee pain, 47 cases were identified of which 36 had a resurfaced patella and 11 had a non-resurfaced patella. Eight of 36 resurfaced patellae underwent surgery while only 2 of 11 non-resurfaced patellae underwent subsequent surgery. More than 3 times as many painful total knees that were referred for evaluation had already had their patella resurfaced. In spite of the fact that approximately equal number of total knees were performed in this area without patella resurfacing, far more patients presented to clinic with painful total knee in which the patella had been resurfaced. The numerous pathologies requiring a treatment following patella resurfacing included patella loosening, fragmentation of the patella, avascular necrosis patella, late stress fracture, lateral facet pain, oblique resurfacing, and too thick of a patellar composite. In a large multi-center randomised clinical trial at 5 years from the United Kingdom in over 1700 knees from 34 centers and 116 surgeons, there was no difference in the Oxford Score, SF-12, EQ-5D, or need for further surgery or complications. The authors concluded, “We see no difference in any score, if there is a difference, it is too small to be of any clinical significance”. In a prospective randomised clinical trial performed at Tulane University over 20 years ago, no differences were observed in knee score, a functional patella questionnaire, or the incidence of anterior knee pain between resurfaced and unresurfaced patellae at time intervals of 2–4 years, 5–7 years, or greater than 10 years. Beyond 10 years the knee scores of total knee patients with a resurfaced patella had declined significantly greater than those with a non-resurfaced patella. There are numerous advantages of not resurfacing the patella including less surgical time, less expense, a lower risk of “major” complications (especially late complications), and if symptoms develop in an unresurfaced patella, it is an easier salvage situation with more options available. A small percentage of total knee patients will be symptomatic whether or not their patella is resurfaced. Not resurfacing the patella retains more options and has fewer complications. The major determinant of clinical result and the presence of anterior knee pain after knee replacement is surgical technique and component design not whether or not the patella is resurfaced. Patella resurfacing is occasionally necessary for patients with inflammatory arthritis, a deformed or maltracking patella, or symptoms and pathology that are virtually restricted to the patellofemoral joint. For the vast majority of patients, however, patella resurfacing is not necessary


Orthopaedic Proceedings
Vol. 87-B, Issue SUPP_III | Pages 339 - 339
1 Sep 2005
MacDonald S Rorabeck C Marr J Clark C Swafford J Macdonald D
Full Access

Introduction and Aims: The dilemma to retain or sacrifice the posterior cruciate ligament in a primary total knee arthroplasty continues to be an area of discussion. A randomised clinical trial was performed comparing clinical, radiographic and quality of life outcomes between patients receiving a posterior cruciate sparing versus posterior cruciate substituting knee implants. Method: A multi-centred, prospective, randomised, blinded, clinical trial was performed to compare posterior cruciate retaining (CR) versus posterior cruciate substitution (PS) in osteoarthritic patients with an intact posterior cruciate ligament, undergoing total knee arthroplasty using the AMK. ®. (Depuy. ®. , Warsaw, Indiana) component. One hundred and fifty-two patients were randomised to receive one of the two devices. Patients were evaluated pre-operatively, at three, six, 12 months and annually thereafter. Patient demographics, radiographs, and multiple validated, outcome measures (WOMAC, SF-12, the Knee Society Clinical Rating System, and a stair climbing test) were evaluated. Patients and assessors were blinded to the implant design. Results: One hundred and fifty-two patients were randomised at three centres; 72 in the CR group and 80 in the PS group. One patient was revised due to instability. Average follow-up was 5.14 years (range 2.97–6.99 years). There were no significant differences in baseline patient demographics between groups. There were no significant differences in outcome measures or radiographic findings. There were no significant differences in the Knee Society Clinical Rating System (CR- 159.18 versus PS- 156.49). There were no differences in knee extension at latest follow-up (CR- 1.02) and (PS- 1.10). There were no differences in knee flexion at latest follow-up (CR-111.00 ) and (PS- 113.61). No differences were noted in the WOMAC and SF-12 scores between the two groups. Conclusion: In this prospective randomised clinical trial no significant differences involving radiographs and multiple outcome measures could be seen between a cruciate retaining versus a posterior stabilised total knee prostheses at a mean follow-up of 5.14 years. Long-term evaluation is necessary to comment on wear, osteolysis and implant longevity


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_II | Pages 249 - 249
1 May 2009
Johnston D Al Yamani M Beaupre L Huckell JR
Full Access

We compared self-reported pain and function, complications and revision rates, and radiographic outcomes of hydroxylapatite(HA) or cemented tibial fixation in the first five years following primary total knee arthroplasty. This was a randomised clinical trial of eighty-one patients. Prospective, randomised clinical trial. Patients less than seventy years of age with non-inflammatory knee arthritis. Eighty-one patients were randomised at the time of surgery to receive HA or cemented tibial fixation. Subjects were evaluated preoperatively, six months, one and five years postoperatively by a physical therapist who was blinded to group allocation. X-rays were evaluated by an experienced arthroplasty surgeon who did not perform any of the surgeries. Self-reported pain and function, the primary outcomes, were measured by the Western Ontario McMaster (WOMAC) Osteoarthritis Index and the RAND 36-item Health Services Inventory (RAND-36). Complications and revision rates were determined through hospital record review and at each patient evaluation. The Knee Society Radiological Score was used to evaluate plain radiographs at each assessment. There was slightly more pain in HA group at six months as measured by both the WOMAC and RAND-36, a difference that disappeared by the one-year assessment. There were no differences in function, radiographic findings or complications at any time. Finally, no subjects required revision of the tibial prosthesis during the study. Overall, no significant differences were seen between groups. The initial difference in self-reported pain disappeared by twelve-months postoperatively. At five-years postoperatively, there is no advantage to HA tibial fixation over cemented tibial fixation


The Bone & Joint Journal
Vol. 98-B, Issue 3 | Pages 395 - 401
1 Mar 2016
Helenius I Keskinen H Syvänen J Lukkarinen H Mattila M Välipakka J Pajulo O

Aims. In a multicentre, randomised study of adolescents undergoing posterior spinal fusion for idiopathic scoliosis, we investigated the effect of adding gelatine matrix with human thrombin to the standard surgical methods of controlling blood loss. Patients and Methods. Patients in the intervention group (n = 30) were randomised to receive a minimum of two and a maximum of four units of gelatine matrix with thrombin in addition to conventional surgical methods of achieving haemostasis. Only conventional surgical methods were used in the control group (n = 30). We measured the intra-operative and total blood loss (intra-operative blood loss plus post-operative drain output). Results. Each additional hour of operating time increased the intra-operative blood loss by 356.9 ml (p < 0.001) and the total blood loss by 430.5 ml (p < 0.001). Multiple linear regression analysis showed that the intervention significantly decreased the intra-operative (-171 ml, p = 0.025) and total blood loss (-177 ml, p = 0.027). The decrease in haemoglobin concentration from the day before the operation to the second post-operative day was significantly smaller in the intervention group (-6 g/l, p = 0.013) than in the control group. . Conclusion. The addition of gelatine matrix with human thrombin to conventional methods of achieving haemostasis reduces both the intra-operative blood loss and the decrease in haemoglobin concentration post-operatively in adolescents undergoing posterior spinal fusion for idiopathic scoliosis. Take home message: A randomised clinical trial showed that gelatine matrix with human thrombin decreases intra-operative blood loss by 30% when added to traditional surgical haemostatic methods in adolescents undergoing posterior spinal fusion for idiopathic scoliosis. Cite this article: Bone Joint J 2016;98-B:395–401


The Journal of Bone & Joint Surgery British Volume
Vol. 86-B, Issue 5 | Pages 639 - 642
1 Jul 2004
Pitto RP Hamer H Heiss-Dunlop W Kuehle J

Routine prophylaxis for venous thromboembolic disease after total hip replacement (THR) is recommended. Pneumatic compression with foot pumps seems to provide an alternative to chemical agents. However, the overall number of patients investigated in randomised clinical trials has been too small to draw evidence-based conclusions. This randomised clinical trial was carried out to compare the effectiveness and safety of mechanical versus chemical prophylaxis of DVT in patients after THR. Inclusion criteria were osteoarthritis of the hip and age less than 80 years. Exclusion criteria included a history of thromboembolic disease, heart disease, and bleeding diatheses. There were 216 consecutive patients considered for inclusion in the trial who were randomised either for management with the A-V Impulse System foot pump. We excluded 16 patients who did not tolerate continuous use of the foot pump or with low-molecular-weight heparin (LMWH). Patients were monitored for DVT using serial duplex sonography at 3, 10 and 45 days after surgery. DVT was detected in three of 100 patients in the foot-pump group and with six of 100 patients in the LMWH group (p < 0.05). The mean post-operative drainage was 259 ml in the foot-pump group and 328 ml in the LMWH group (p < 0.05). Patients in the foot-pump group had less swelling of the thigh (10 mm compared with 15 mm; p < 0.05). One patient developed heparin-induced thrombocytopenia. This study confirms the effectiveness and safety of mechanical prophylaxis of DVT in THR. Some patients cannot tolerate the foot pump


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_8 | Pages 23 - 23
1 May 2019
Jobin C
Full Access

Durable humeral component fixation in shoulder arthroplasty is necessary to prevent painful aseptic loosening and resultant humeral bone loss. Causes of humeral component loosening include stem design and material, stem length and geometry, ingrowth vs. ongrowth surfaces, quality of bone available for fixation, glenoid polyethylene debris osteolysis, exclusion of articular particulate debris, joint stability, rotator cuff function, and patient activity levels. Fixation of the humeral component may be achieved by cement fixation either partial or complete and press-fit fixation. During the past two decades, uncemented humeral fixation has become more popular, especially with short stems and stemless press fit designs. Cemented humeral component fixation risks difficult and complicated revision surgery, stress shielding of the tuberosities and humeral shaft periprosthetic fractures at the junction of the stiff cemented stem and the remaining humeral shaft. Press fit fixation may minimise these cemented risks but has potential for stem loosening. A randomised clinical trial of 161 patients with cemented vs. press fit anatomic total shoulder replacements found that cemented fixation of the humeral component provided better quality of life, strength, and range of motion than uncemented fixation but longer operative times. Another study found increased humeral osteolysis (43%) associated with glenoid component loosening and polyethylene wear, while stress shielding was seen with well-fixed press fit humeral components. During reverse replacement the biomechanical forces are different on the humeral stem. Stem loosening during reverse replacement may have different factors than anatomic replacement. A systemic review of 41 reverse arthroplasty clinical studies compared the functional outcomes and complications of cemented and uncemented stems in approximately 1800 patients. There was no difference in the risk of stem loosening or revision between cemented and uncemented stems. Uncemented stems have at least equivalent clinical and radiographic outcomes compared with cemented stems during reverse shoulder arthroplasty. Durable humeral component fixation in shoulder arthroplasty is associated with fully cemented stems or well ingrown components that exclude potential synovial debris that may cause osteolysis


The Bone & Joint Journal
Vol. 95-B, Issue 11 | Pages 1570 - 1574
1 Nov 2013
Maripuri SN Gallacher PD Bridgens J Kuiper JH Kiely NT

We undertook a randomised clinical trial to compare treatment times and failure rates between above- and below-knee Ponseti casting groups. Eligible children with idiopathic clubfoot, treated using the Ponseti method, were randomised to either below- or above-knee plaster of Paris casting. Outcome measures were total treatment time and the occurrence of failure, defined as two slippages or a treatment time above eight weeks. A total of 26 children (33 feet) were entered into the trial. The above-knee group comprised 17 feet in 13 children (ten boys and three girls, median age 13 days (1 to 40)) and the below-knee group comprised 16 feet in 13 children (ten boys and three girls, median age 13 days (5 to 20)). Because of six failures (37.5%) in the below-knee group, the trial was stopped early for ethical reasons. The rate of failure was significantly higher in the below-knee group (p = 0.039). The median treatment times of six weeks in the below-knee and four weeks in the above-knee group differed significantly (p = 0.01). This study demonstrates that the use of a below-knee plaster of Paris cast in conjunction with the Ponseti technique leads to unacceptably high failure rates and significantly longer treatment times. Therefore, this technique is not recommended. Cite this article: Bone Joint J 2013;95-B:1570–4


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_10 | Pages 106 - 106
1 Jun 2018
Abdel M
Full Access

Over the past 30 years, cemented, cementless, and hybrid fixation options have been utilised with various total knee arthroplasty (TKA) implant systems. While cemented components are widely used and considered the most reliable method of fixation, historical results may not be applicable to contemporary patients, who are increasingly younger than 65 years of age. Moreover, the literature is not definitive on which method of TKA fixation obtains the best clinical, functional, and radiographic results. A recent Cochrane meta-analysis on roentgen stereophotogrammetric analysis (RSA) included five randomised clinical trials (RCTs) in 297 participants. The authors observed that cemented fixation of tibial components demonstrated smaller displacement in relation to cementless fixation. However, the risk of future aseptic loosening with uncemented fixation was approximately half that of cemented fixation (risk ratio = 0.47, 95% CI 0.24 to 0.92) with a 16% absolute risk difference between groups. Almost all included studies recorded functional measures of Knee Society and Hospital for Special Surgery knee scores, but the authors of each study found no significant difference between the groups. Recently, highly porous metals have become an attractive fixation option in TKA due to their biomechanical properties. In a large RCT of 397 patients, Pulido et al found that uncemented highly porous metal tibias provided comparably durable fixation and reliable pain relief and restoration of function when compared with traditional cemented modular tibias. While longer term studies are needed, cementless TKAs may be a durable and reliable alternative with highly porous metals, particularly in younger patients


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_10 | Pages 38 - 38
1 Jun 2018
Pagnano M
Full Access

Tranexamic acid (TXA) is an effective medication to limit blood loss and transfusion requirements in association with contemporary total joint arthroplasty. TXA is in a class of medications termed anti-fibrinolytics due to their action to limit the breakdown of clot that has already been formed. It is useful to note that TXA does not promote the formation of clot, it simply limits the breakdown of already established clot. A recent systematic review and meta-analysis of randomised clinical trials of TXA use in total hip replacement demonstrated: 1) a substantial reduction in the proportion of patients who required transfusion and 2) no increase in DVT or PE. Similarly a recent Cochrane Database systematic review assessed Anti-fibrinolytic Use for Minimizing Perioperative Blood Transfusion and found tranexamic acid to be effective in reducing blood loss during and after surgery and to be free of serious adverse effects. In orthopaedic surgery varying doses have been used over time. A pragmatic dosing approach for Total Knee and Total Hip patients has been used at the Mayo Clinic over the past 16 years: 1 gram IV over 10 minutes prior to incision (delivered at same time as pre-op antibiotics) followed by 1 gram IV over 10 minutes at the time wound closure is initiated. Infusion rates greater than 100 mg/minute have been associated with hypotension and thus the recommendation for 1 gram over 10 minutes. A recent review of 1500 TKA patients at Mayo Clinic revealed a very low prevalence of clinically symptomatic DVT and PE when tranexamic acid was used with 3 different thromboembolic prophylaxis regimens (aspirin and foot pumps; coumadin; low molecular weight heparin). The safety of TXA for patients with coronary stents has not been fully clarified


The Journal of Bone & Joint Surgery British Volume
Vol. 91-B, Issue 11 | Pages 1459 - 1465
1 Nov 2009
Luites JWH Brinkman J Wymenga AB van Heerwaarden RJ

Valgus high tibial osteotomy for osteoarthritis of the medial compartment of the knee can be performed using medial opening- and lateral closing-wedge techniques. The latter have been thought to offer greater initial stability. We measured and compared the stability of opening- and closing-wedge osteotomies fixed by TomoFix plates using radiostereometry in a series of 42 patients in a prospective, randomised clinical trial. There were no differences between the opening- and closing-wedge groups in the time to regain knee function and full weight-bearing. Pain and knee function were significantly improved in both groups without any differences between them. All the osteotomies united within one year. Radiostereometry showed no clinically relevant movement of bone or differences between either group. Medial opening-wedge high tibial osteotomy secured by a TomoFix plate offers equal stability to a lateral closing-wedge technique. Both give excellent initial stability and provide significantly improved knee function and reduction in pain, although the opening-wedge technique was more likely to produce the intended correction