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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


The Bone & Joint Journal
Vol. 103-B, Issue 6 Supple A | Pages 126 - 130
1 Jun 2021
Chalmers BP Goytizolo E Mishu MD Westrich GH

Aims. Manipulation under anaesthesia (MUA) remains an effective intervention to address restricted range of motion (ROM) after total knee arthroplasty (TKA) and occurs in 2% to 3% of primary TKAs at our institution. Since there are few data on the outcomes of MUA with different anaesthetic methods, we sought to compare the outcomes of patients undergoing MUA with intravenous (IV) sedation and neuraxial anaesthesia. Methods. We identified 548 MUAs after primary TKA (136 IV sedation, 412 neuraxial anaesthesia plus IV sedation) from March 2016 to July 2019. The mean age of this cohort was 62 years (35 to 88) with a mean body mass index of 31 kg/m. 2. (18 to 49). The mean time from primary TKA to MUA was 10.2 weeks (6.2 to 24.3). Pre-MUA ROM was similar between groups; overall mean pre-MUA extension was 4.2° (p = 0.452) and mean pre-MUA flexion was 77° (p = 0.372). We compared orthopaedic complications, visual analogue scale (VAS) pain scores, length of stay (LOS), and immediate and three-month follow-up knee ROM between these groups. Results. Following MUA, patients with IV sedation had higher mean VAS pain scores of 5.2 (SD 1.8) compared to 4.1 (SD = 1.5) in the neuraxial group (p < 0.001). The mean LOS was shorter in patients that received IV sedation (9.5 hours (4 to 31)) compared to neuraxial anaesthesia (11.9 hours (4 to 51)) (p = 0.009), but an unexpected overnight stay was similar in each group (8.6%). Immediate-post MUA ROM was 1° to 121° in the IV sedation group and 0.9° to 123° in the neuraxial group (p = 0.313). Three-month follow-up ROM was 2° to 108° in the IV sedation group and 1.9° to 110° in the neuraxial anaesthesia group (p = 0.325) with a mean loss of 13° (ranging from 5° gain to 60° loss), in both groups by three months. No patients in either group sustained a complication. Conclusion. IV sedation alone and neuraxial anaesthesia are both effective anaesthetic methods for MUA after primary TKA. Surgeons and anaesthetists should offer these anaesthetic techniques to match patient-specific needs as the orthopaedic outcomes are similar. Also, patients should be counselled that ROM following MUA may decrease over time. Cite this article: Bone Joint J 2021;103-B(6 Supple A):126–130


The Bone & Joint Journal
Vol. 101-B, Issue 3 | Pages 331 - 339
1 Mar 2019
McEwen P Balendra G Doma K

Aims. The results of kinematic total knee arthroplasty (KTKA) have been reported in terms of limb and component alignment parameters but not in terms of gap laxities and differentials. In kinematic alignment (KA), balance should reflect the asymmetrical balance of the normal knee, not the classic rectangular flexion and extension gaps sought with gap-balanced mechanical axis total knee arthroplasty (MATKA). This paper aims to address the following questions: 1) what factors determine coronal joint congruence as measured on standing radiographs?; 2) is flexion gap asymmetry produced with KA?; 3) does lateral flexion gap laxity affect outcomes?; 4) is lateral flexion gap laxity associated with lateral extension gap laxity?; and 5) can consistent ligament balance be produced without releases?. Patients and Methods. A total of 192 KTKAs completed by a single surgeon using a computer-assisted technique were followed for a mean of 3.5 years (2 to 5). There were 116 male patients (60%) and 76 female patients (40%) with a mean age of 65 years (48 to 88). Outcome measures included intraoperative gap laxity measurements and component positions, as well as joint angles from postoperative three-foot standing radiographs. Patient-reported outcome measures (PROMs) were analyzed in terms of alignment and balance: EuroQol (EQ)-5D visual analogue scale (VAS), Knee Injury and Osteoarthritis Outcome Score (KOOS), KOOS Joint Replacement (JR), and Oxford Knee Score (OKS). Results. Postoperative limb alignment did not affect outcomes. The standing hip-knee-ankle (HKA) angle was the sole positive predictor of the joint line convergence angle (JLCA) (p < 0.001). Increasing lateral flexion gap laxity was consistently associated with better outcomes. Lateral flexion gap laxity did not correlate with HKA angle, the JLCA, or lateral extension gap laxity. Minor releases were required in one third of cases. Conclusion. The standing HKA angle is the primary determinant of the JLCA in KTKA. A rectangular flexion gap is produced in only 11% of cases. Lateral flexion gap laxity is consistently associated with better outcomes and does not affect balance in extension. Minor releases are sometimes required as well, particularly in limbs with larger preoperative deformities. Cite this article: Bone Joint J 2019;101-B:331–339


The Journal of Bone & Joint Surgery British Volume
Vol. 90-B, Issue 2 | Pages 166 - 171
1 Feb 2008
Lundblad H Kreicbergs A Jansson K

We suggest that different mechanisms underlie joint pain at rest and on movement in osteoarthritis and that separate assessment of these two features with a visual analogue scale (VAS) offers better information about the likely effect of a total knee replacement (TKR) on pain. The risk of persistent pain after TKR may relate to the degree of central sensitisation before surgery, which might be assessed by determining the pain threshold to an electrical stimulus created by a special tool, the Pain Matcher. Assessments were performed in 69 patients scheduled for TKR. At 18 months after operation, separate assessment of pain at rest and with movement was again carried out using a VAS in order to enable comparison of pre- and post-operative measurements. A less favourable outcome in terms of pain relief was observed for patients with a high pre-operative VAS score for pain at rest and a low pain threshold, both features which may reflect a central sensitisation mechanism


The Bone & Joint Journal
Vol. 98-B, Issue 6 | Pages 793 - 798
1 Jun 2016
Kohl S Evangelopoulos DS Schär MO Bieri K Müller T Ahmad SS

Aims. The purpose of this study was to report the experience of dynamic intraligamentary stabilisation (DIS) using the Ligamys device for the treatment of acute ruptures of the anterior cruciate ligament (ACL). Patients and Methods. Between March 2011 and April 2012, 50 patients (34 men and 16 women) with an acute rupture of the ACL underwent primary repair using this device. The mean age of the patients was 30 years (18 to 50). Patients were evaluated for laxity, stability, range of movement (ROM), Tegner, Lysholm, International Knee Documentation Committee (IKDC) and visual analogue scale (VAS) scores over a follow-up period of two years. Results. At final follow-up, anteroposterior translation differed from the normal knee by a mean of 0.96 mm (-2 mm to 6 mm). Median (interquartile range) IKDC, Tegner, Lysholm and VAS scores were 98 (95 to 100), 6 (5 to 7), 100 (98 to 100) and 10 (9 to 10), respectively. Pre-injury Tegner activity levels were reached one year post-operatively. A total of nine patients (18%) required a secondary intervention; five developed instability, of whom four underwent secondary hamstring reconstructive surgery, and five required arthroscopic treatment for intra-articular impingement due to scar tissue which caused a fixed flexion deformity. In addition, 30 patients (60%) required removal of the tibial screw. Conclusion. While there was a high rate of secondary interventions, 45 patients (90%) retained their repaired ACL two years post-operatively, with good clinical scores and stability of the knee. Take home message: Dynamic intraligamentary stabilisation presents a promising treatment option for acute ACL ruptures, eliminating the need for ACL reconstruction. Cite this article: Bone Joint J 2016;98-B:793–8


The Bone & Joint Journal
Vol. 97-B, Issue 5 | Pages 649 - 653
1 May 2015
Hawi N Kendoff D Citak M Gehrke T Haasper C

Knee arthrodesis is a potential salvage procedure for limb preservation after failure of total knee arthroplasty (TKA) due to infection. In this study, we evaluated the outcome of single-stage knee arthrodesis using an intramedullary cemented coupled nail without bone-on-bone fusion after failed and infected TKA with extensor mechanism deficiency. Between 2002 and 2012, 27 patients (ten female, 17 male; mean age 68.8 years; 52 to 87) were treated with septic single-stage exchange. Mean follow-up duration was 67.1months (24 to 143, n = 27) (minimum follow-up 24 months) and for patients with a minimum follow-up of five years 104.9 (65 to 143,; n = 13). A subjective patient evaluation (Short Form (SF)-36) was obtained, in addition to the Visual Analogue Scale (VAS). The mean VAS score was 1.44 (SD 1.48). At final follow-up, four patients had recurrent infections after arthrodesis (14.8%). Of these, three patients were treated with a one-stage arthrodesis nail exchange; one of the three patients had an aseptic loosening with a third single-stage exchange, and one patient underwent knee amputation for uncontrolled sepsis at 108 months. All patients, including the amputee, indicated that they would choose arthrodesis again. Data indicate that a single-stage knee arthrodesis offers an acceptable salvage procedure after failed and infected TKA. Cite this article: Bone Joint J 2015;97-B:649–53


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 cm2) 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.


The Bone & Joint Journal
Vol. 105-B, Issue 4 | Pages 365 - 372
15 Mar 2023
Yapp LZ Scott CEH MacDonald DJ Howie CR Simpson AHRW Clement ND

Aims

This study investigates whether primary knee arthroplasty (KA) restores health-related quality of life (HRQoL) to levels expected in the general population.

Methods

This retrospective case-control study compared HRQoL data from two sources: patients undergoing primary KA in a university-teaching hospital (2013 to 2019), and the Health Survey for England (HSE; 2010 to 2012). Patient-level data from the HSE were used to represent the general population. Propensity score matching was used to balance covariates and facilitate group comparisons. A propensity score was estimated using logistic regression based upon the covariates sex, age, and BMI. Two matched cohorts with 3,029 patients each were obtained for the adjusted analyses (median age 70.3 (interquartile range (IQR) 64 to 77); number of female patients 3,233 (53.4%); median BMI 29.7 kg/m2 (IQR 26.5 to 33.7)). HRQoL was measured using the three-level version of the EuroQol five-dimension questionnaire (EQ-5D-3L), and summarized using the Index and EuroQol visual analogue scale (EQ-VAS) scores.


The Bone & Joint Journal
Vol. 106-B, Issue 5 | Pages 450 - 459
1 May 2024
Clement ND Galloway S Baron J Smith K Weir DJ Deehan DJ

Aims

The aim was to assess whether robotic-assisted total knee arthroplasty (rTKA) had greater knee-specific outcomes, improved fulfilment of expectations, health-related quality of life (HRQoL), and patient satisfaction when compared with manual TKA (mTKA).

Methods

A randomized controlled trial was undertaken (May 2019 to December 2021), and patients were allocated to either mTKA or rTKA. A total of 100 patients were randomized, 50 to each group, of whom 43 rTKA and 38 mTKA patients were available for review at 12 months following surgery. There were no statistically significant preoperative differences between the groups. The minimal clinically important difference in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score was defined as 7.5 points.


The Bone & Joint Journal
Vol. 106-B, Issue 1 | Pages 38 - 45
1 Jan 2024
Leal J Mirza B Davies L Fletcher H Stokes J Cook JA Price A Beard DJ

Aims

The aim of this study was to estimate the incremental use of resources, costs, and quality of life outcomes associated with surgical reconstruction compared to rehabilitation for long-standing anterior cruciate ligament (ACL) injury in the NHS, and to estimate its cost-effectiveness.

Methods

A total of 316 patients were recruited and randomly assigned to either surgical reconstruction or rehabilitation (physiotherapy but with subsequent reconstruction permitted if instability persisted after treatment). Healthcare resource use and health-related quality of life data (EuroQol five-dimension five-level health questionnaire) were collected in the trial at six, 12, and 18 months using self-reported questionnaires and medical records. Using intention-to-treat analysis, differences in costs, and quality-adjusted life years (QALYs) between treatment arms were estimated adjusting for baseline differences and following multiple imputation of missing data. The incremental cost-effectiveness ratio (ICER) was estimated as the difference in costs divided by the difference in QALYs between reconstruction and rehabilitation.


The Bone & Joint Journal
Vol. 105-B, Issue 9 | Pages 961 - 970
1 Sep 2023
Clement ND Galloway S Baron YJ Smith K Weir DJ Deehan DJ

Aims

The primary aim was to assess whether robotic total knee arthroplasty (rTKA) had a greater early knee-specific outcome when compared to manual TKA (mTKA). Secondary aims were to assess whether rTKA was associated with improved expectation fulfilment, health-related quality of life (HRQoL), and patient satisfaction when compared to mTKA.

Methods

A randomized controlled trial was undertaken, and patients were randomized to either mTKA or rTKA. The primary objective was functional improvement at six months. Overall, 100 patients were randomized, 50 to each group, of whom 46 rTKA and 41 mTKA patients were available for review at six months following surgery. There were no differences between the two groups.


The Bone & Joint Journal
Vol. 104-B, Issue 7 | Pages 875 - 883
1 Jul 2022
Mills K Wymenga AB van Hellemondt GG Heesterbeek PJC

Aims

Both the femoral and tibial component are usually cemented at revision total knee arthroplasty (rTKA), while stems can be added with either cemented or press-fit (hybrid) fixation. The aim of this study was to compare the long-term stability of rTKA with cemented and press-fitted stems, using radiostereometric analysis (RSA).

Methods

This is a follow-up of a randomized controlled trial, initially involving 32 patients, of whom 19 (nine cemented, ten hybrid) were available for follow-up ten years postoperatively, when further RSA measurements were made. Micromotion of the femoral and tibial components was assessed using model-based RSA software (RSAcore). The clinical outcome was evaluated using the Knee Society Score (KSS), the Knee injury and Osteoarthritis Outcome Score (KOOS), and visual analogue scale (pain and satisfaction).


The Bone & Joint Journal
Vol. 104-B, Issue 6 | Pages 663 - 671
1 Jun 2022
Lewis E Merghani K Robertson I Mulford J Prentice B Mathew R Van Winden P Ogden K

Aims

Platelet-rich plasma (PRP) intra-articular injections may provide a simple and minimally invasive treatment for early-stage knee osteoarthritis (OA). This has led to an increase in its adoption as a treatment for knee OA, although there is uncertainty about its efficacy and benefit. We hypothesized that patients with early-stage symptomatic knee OA who receive multiple PRP injections will have better clinical outcomes than those receiving single PRP or placebo injections.

Methods

A double-blinded, randomized placebo-controlled trial was performed with three groups receiving either placebo injections (Normal Saline), one PRP injection followed by two placebo injections, or three PRP injections. Each injection was given one week apart. Outcomes were prospectively collected prior to intervention and then at six weeks, three months, six months, and 12 months post-intervention. Primary outcome measures were Knee Injury and Osteoarthritis Outcome Score (KOOS) and EuroQol five-dimension five-level index (EQ-5D-5L). Secondary outcomes included visual analogue scale for pain and patient subjective assessment of the injections.


The Bone & Joint Journal
Vol. 103-B, Issue 10 | Pages 1561 - 1570
1 Oct 2021
Blyth MJG Banger MS Doonan J Jones BG MacLean AD Rowe PJ

Aims

The aim of this study was to compare the clinical outcomes of robotic arm-assisted bi-unicompartmental knee arthroplasty (bi-UKA) with conventional mechanically aligned total knee arthroplasty (TKA) during the first six weeks and at one year postoperatively.

Methods

A per protocol analysis of 76 patients, 43 of whom underwent TKA and 34 of whom underwent bi-UKA, was performed from a prospective, single-centre, randomized controlled trial. Diaries kept by the patients recorded pain, function, and the use of analgesics daily throughout the first week and weekly between the second and sixth weeks. Patient-reported outcome measures (PROMs) were compared preoperatively, and at three months and one year postoperatively. Data were also compared longitudinally and a subgroup analysis was conducted, stratified by preoperative PROM status.


The Bone & Joint Journal
Vol. 103-B, Issue 9 | Pages 1514 - 1525
1 Sep 2021
Scott CEH Holland G Gillespie M Keenan OJ Gherman A MacDonald DJ Simpson AHRW Clement ND

Aims

The aims of this study were to investigate the ability to kneel after total knee arthroplasty (TKA) without patellar resurfacing, and its effect on patient-reported outcome measures (PROMs). Secondary aims included identifying which kneeling positions were most important to patients, and the influence of radiological parameters on the ability to kneel before and after TKA.

Methods

This prospective longitudinal study involved 209 patients who underwent single radius cruciate-retaining TKA without patellar resurfacing. Preoperative EuroQol five-dimension questionnaire (EQ-5D), Oxford Knee Score (OKS), and the ability to achieve four kneeling positions were assessed including a single leg kneel, a double leg kneel, a high-flexion kneel, and a praying position. The severity of radiological osteoarthritis (OA) was graded and the pattern of OA was recorded intraoperatively. The flexion of the femoral component, posterior condylar offset, and anterior femoral offset were measured radiologically. At two to four years postoperatively, 151 patients with a mean age of 70.0 years (SD 9.44) were included. Their mean BMI was 30.4 kg/m2 (SD 5.36) and 60 were male (40%). They completed EQ-5D, OKS, and Kujala scores, assessments of the ability to kneel, and a visual analogue scale for anterior knee pain and satisfaction.


The Bone & Joint Journal
Vol. 103-B, Issue 6 Supple A | Pages 108 - 112
1 Jun 2021
Kahlenberg CA Krell EC Sculco TP Katz JN Nguyen JT Figgie MP Sculco PK

Aims

Many patients undergoing total knee arthroplasty (TKA) have severe osteoarthritis (OA) in both knees and may consider either simultaneous or staged bilateral TKA. The implications of simultaneous versus staged bilateral TKA for return to work are not well understood. We hypothesized that employed patients who underwent simultaneous bilateral TKA would have significantly fewer days missed from work compared with the sum of days missed from each operation for patients who underwent staged bilateral TKA.

Methods

The prospective arthroplasty registry at the Hospital for Special Surgery was used. Baseline characteristics and patient-reported outcome scores were evaluated. We used a linear regression model, adjusting for potential confounding variables including age, sex, preoperative BMI, and type of work (sedentary, moderate, high activity, or strenuous), to analyze time lost from work after simultaneous compared with staged bilateral TKA.


The Bone & Joint Journal
Vol. 103-B, Issue 6 | Pages 1096 - 1102
1 Jun 2021
Hamilton DF Shim J Howie CR Macfarlane GJ

Aims

Although total knee arthroplasty (TKA) is a highly successful procedure, about 20% of patients remain dissatisfied postoperatively. This proportion is derived from dichotomous models of the assessment of surgical success or failure, which may not reflect the spectrum of outcomes. The aim of this study was to explore differing responses to surgery, and assess whether there are distinct groups of patients with differing patterns of outcome.

Methods

This was a secondary analysis of a UK multicentre TKA longitudinal cohort study. We used a group-based trajectory modelling analysis of Oxford Knee Score (OKS) in the first year following surgery with longitudinal data involving five different timepoints and multiple predictor variables. Associations between the derived trajectory groups and categorical baseline variables were assessed, and predictors of trajectory group membership were identified using Poisson regression and multinomial logistic regression, as appropriate. The final model was adjusted for sociodemographic factors (age, sex) and baseline OKS.


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.


The Bone & Joint Journal
Vol. 103-B, Issue 4 | Pages 627 - 634
1 Apr 2021
Sabah SA Alvand A Beard DJ Price AJ

Aims

To estimate the measurement properties for the Oxford Knee Score (OKS) in patients undergoing revision knee arthroplasty (responsiveness, minimal detectable change (MDC-90), minimal important change (MIC), minimal important difference (MID), internal consistency, construct validity, and interpretability).

Methods

Secondary data analysis was performed for 10,727 patients undergoing revision knee arthroplasty between 2013 to 2019 using a UK national patient-reported outcome measure (PROM) dataset. Outcome data were collected before revision and at six months postoperatively, using the OKS and EuroQol five-dimension score (EQ-5D). Measurement properties were assessed according to COnsensus-based Standards for the selection of health status Measurement Instruments (COSMIN) guidelines.


The Bone & Joint Journal
Vol. 102-B, Issue 6 Supple A | Pages 10 - 18
1 Jun 2020
Ueyama H Kanemoto N Minoda Y Taniguchi Y Nakamura H

Aims

The aim of this study was to assess the effectiveness of perioperative essential amino acid (EAA) supplementation to prevent rectus femoris muscle atrophy and facilitate early recovery of function after total knee arthroplasty (TKA).

Methods

The study involved 60 patients who underwent unilateral TKA for primary knee osteo-arthritis (OA). This was a double-blind, placebo-controlled, randomized control trial with patients randomly allocated to two groups, 30 patients each: the essential amino acid supplementation (9 g daily) and placebo (lactose powder, 9 g daily) groups. Supplementation and placebo were provided from one week before to two weeks after surgery. The area of the rectus femoris muscle were measured by ultrasound imaging one month before surgery and one, two, three, and four weeks postoperatively. The serum albumin level, a visual analogue knee pain score, and mobility were also measured at each time point. The time to recovery of activities of daily living (ADLs) was recorded. Postoperative nutrition and physiotherapy were identical in both groups.