Dataset Information

Synovectomy during total knee arthroplasty: a pilot single-centre randomised controlled trial.

ABSTRACT:

Background

Total knee arthroplasty (TKA) is an effective procedure for late-stage osteoarthritis (OA) of the knee; however, up to 20% of patients remain dissatisfied. In some patients, this may be due to residual inflammation of the synovium. Our aim was to perform the first randomised controlled trial (RCT) of synovectomy during TKA for patients with macroscopically inflamed synovium. The main objectives were to assess recruitment rates, protocol adherence and outcomes relating to safety such as haemoglobin decrease and adverse events. We also collected data on patient-reported outcomes.

Methods

We performed a single-centre pilot RCT. Patients with a macroscopically inflamed synovium were randomised to receive synovectomy versus a control group that did not undergo synovectomy. We determined feasibility by measuring patient enrolment, completeness of follow-up, and safety via haemoglobin decrease and documentation of adverse events.

Results

We screened 360 patients with 260 deemed ineligible or could not be recruited. From the 100 eligible patients, 54 were enrolled and 40 progressed through to randomisation. All made it to the 12-month follow-up, indicating good protocol adherence. There were no major differences in adverse events or haemoglobin decrease demonstrating acceptable safety. Outcomes relating to satisfaction were reliably obtained.

Conclusions

Patients with macroscopically inflamed synovium of the knee who are due to undergo TKA can be reliably recruited to a randomised trial and synovectomy can be performed safely. A large number is needed to be screened to identify eligible participants, and therefore, a multi-centre trial would be required to assess whether routine synovectomy would improve outcomes in these patients.

Trial registration

ISRCTN, ISRCTN31010214. Registered 6 October 2016-retrospectively registered.

SUBMITTER: Rankin KS

PROVIDER: S-EPMC6109454 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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Publications

Synovectomy during total knee arthroplasty: a pilot single-centre randomised controlled trial.

Rankin Kenneth S KS Ramaskandhan Jayasree J Bardgett Michelle M Merrie Katie K Gangadharan Rajkumar R Wilson Ian I Deehan David D

Pilot and feasibility studies 20180825

<h4>Background</h4>Total knee arthroplasty (TKA) is an effective procedure for late-stage osteoarthritis (OA) of the knee; however, up to 20% of patients remain dissatisfied. In some patients, this may be due to residual inflammation of the synovium. Our aim was to perform the first randomised controlled trial (RCT) of synovectomy during TKA for patients with macroscopically inflamed synovium. The main objectives were to assess recruitment rates, protocol adherence and outcomes relating to safet ...[more]

PMID: 30151238

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Project description:IntroductionTotal knee arthroplasty (TKA) surgery causes postoperative pain. The use of perioperative injections around the knee containing local anaesthetic, opiates and non-steroidal anti-inflammatory drugs has increased in popularity to manage pain. Theoretical advantages include reduced requirements for analgesia and earlier mobilisation. We propose a single-centre randomised controlled trial of multimodal periarticular anaesthetic infiltration versus femoral nerve anaesthetic blockade as analgesia for TKA. The aim is to determine, in patients undergoing TKA, if there is a difference in patient-reported pain scores on the visual analogue scale (VAS) prior to physiotherapy on day 1 postoperatively between treatment groups.Methods and analysisPatients undergoing a primary unilateral TKA at University Hospitals Coventry and Warwickshire Hospitals will be assessed for eligibility. A total of 264 patients will provide 90% power to detect a difference of 12 mm on the VAS on day 1 postoperatively at the 5% level. The trial will use 1:1 randomisation, stratified by mode of anaesthetic. Primary outcome measure will be the VAS for pain prior to physiotherapy on day 1. Secondary outcome measures include VAS on day 2, total use of opiate analgesia up to 48 h, ordinal pain scores up to 40 min after surgery, independent functional knee physiotherapist assessment on days 1 and 2. Oxford knee Scores (OKS), EuroQol (EQ-5D) and Douleur Neuropathic Pain Scores (DN2) will be recorded at baseline, 6 weeks and 12 months. Adverse events will be recorded up to 12 months. Analysis will investigate differences in VAS on day 1 between the two treatment groups on an intention-to-treat basis. Tests will be two-sided and considered to provide evidence for a significant difference if p values are less than 0.05.Ethics and disseminationNRES Committee West Midlands, 23 September 2013 (ref: 13/WM/0316). The results will be disseminated via peer-reviewed publications and conference presentations.Trial registration numbersISRCTN 60611146 and EUDRACT Number 2013-002439-10 (protocol code number PAKA-33601-AS117013); Pre-results.

Project description:BackgroundThe purpose of this study was to assess the effect of preoperative physiotherapy (PT) on functional, subjective and socio-economic parameters after total knee arthroplasty (TKA).Methods20 patients (mean ± SD: age 67 ± 7 years) scheduled for TKA at Balgrist University Hospital between July 2016 and March 2017 were randomly assigned to a control (CG) or intervention (IG) group. 3 to 4 weeks prior to surgery the IG completed 5 to 9 sessions of PT containing proprioceptive neuromuscular facilitation (PNF) techniques, endurance training and individually indicated interventions. Measurements were executed at baseline, preoperative and 3 months after TKA. The primary outcome measure was the Stair Climbing Test (SCT), secondary outcome measures were the knee range of motion (ROM) and the level of physical activity using Lysholm Score (LS) and Tegner Activity Scale (TAS). The subjective and socio-economic parameters were the Patients' Global Impression of Change (PGIC) scale, inpatient rehabilitation time, preoperative pain levels and metabolic equivalent (MET), postoperative intake of analgesics and overall costs.ResultsNo difference between IG and CG was found for SCT (F (2/36) = 0.016, p = 0.984, η2 = 0.004). An interaction between group and time was shown for TAS (F (18/1) = 13.890) with an increase in the IG (p = 0.002, η2 = 0.536). The sub-item "pain" within the LS presented a higher pain-level in CG (F (18/1) = 4.490, p = 0.048, η2 = 0.974), while IG showed a higher preoperative MET compared to CG (p = 0.035). There were no other significant changes. The CG produced 21.4% higher overall costs, took more analgesics and showed higher preoperative pain levels than the IG.ConclusionsFindings show that preoperative therapy improved the level of physical activity before and after TKA and resulted in a clinically relevant gain in TAS.Trial registrationClinicalTrials.gov Identifier; NCT03160534. Registered 19 May 2017.

Dataset Information

Synovectomy during total knee arthroplasty: a pilot single-centre randomised controlled trial.

Background

Methods

Results

Conclusions

Trial registration

Publications

Synovectomy during total knee arthroplasty: a pilot single-centre randomised controlled trial.

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