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Total or Partial Knee Arthroplasty Trial - TOPKAT: study protocol for a randomised controlled trial.

David Beard¹, Andrew Price, Jonathan Cook

¹Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, University of Oxford, Headington, Oxford OX3 7LD, UK. david.beard@ndorms.ox.ac.uk.

|September 14, 2013

Summary

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Clinical Trials

Clinical Trials

Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...

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This study compares total knee replacement (TKR) with unicompartment knee replacement (UKR) for medial compartment osteoarthritis. It assesses which procedure offers better clinical outcomes and cost-effectiveness over five years.

Area of Science:

Orthopaedic surgery
Biomedical engineering
Clinical trials

Background:

Osteoarthritis (OA) of the knee commonly affects the medial compartment.
Treatment options include total knee replacement (TKR) or unicompartment knee replacement (UKR).
Evidence on the comparative clinical and cost-effectiveness of TKR versus UKR is limited, leading to varied surgical practices.

Purpose of the Study:

To evaluate the clinical and cost-effectiveness of TKRs compared to UKRs in patients with medial compartment knee OA.
To provide evidence to guide surgical decision-making for unicompartmental knee disease.

Main Methods:

A multicentre, superiority, randomised controlled trial (RCT) design.
Recruitment of 500 patients undergoing unilateral knee replacement across 28 UK orthopaedic units.

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Randomisation to either UKR or TKR, with follow-up for 5 years, assessing the Oxford Knee Score as the primary outcome.

Main Results:

The primary outcome measure is the Oxford Knee Score, collected at 2 months, 1 year, and annually up to 5 years.
Secondary outcomes include cost-effectiveness, patient satisfaction, and complication rates.
Blinding is not feasible due to differing surgical scars between TKR and UKR.

Conclusions:

The TOPKAT study aims to determine the optimal surgical approach for medial compartment knee osteoarthritis.
Findings will inform clinical practice and patient management regarding knee replacement strategies.
The study will contribute valuable data on the long-term efficacy and economic impact of TKR versus UKR.