NCT03196011

Traditional Versus Alternative Alignment in TKR

Active, enrolled NA Last updated 30 January 2025

What this trial tests

NA trial testing TKR with mechanical alignment method in Osteo Arthritis Knee in 126 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

23 October 2018

Primary endpoint
31 October 2025

31 December 2025

Quick facts

Lead sponsor	Royal Devon and Exeter NHS Foundation Trust
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	126
Start date	23 October 2018
Primary completion	31 October 2025
Estimated completion	31 December 2025
Sites	1 location across United Kingdom

Drugs / interventions tested

• TKR with mechanical alignment method
• TKR with alternative alignment method

Conditions studied

• Osteo Arthritis Knee — all drugs for Osteo Arthritis Knee →

Sponsor

Royal Devon and Exeter NHS Foundation Trust

Who can join

Adults 60 to 120, any sex, with Osteo Arthritis Knee. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

As many as 20% of patients are unhappy with the results of total knee replacement (TKR). Various changes to surgical technique have tried to address this but have not led to a significant improvement in the numbers of patients satisfied with their operation.

Recently, attention has focussed on alignment of the leg. When viewed from the front, a number of people do not start with a straight, mechanically aligned leg. Traditionally, when implanting a knee replacement, the surgeon tries to put the shin bone half of the knee replacement perpendicular to the floor to equalise stresses on the in and outside of the joint. However, this may result in the alignment of the leg changing considerably, straining the soft tissues around the knee and contributing to dissatisfaction with TKR.

There has been a move by some surgeons to change practice, and to implant the TKR in a way that replicates the alignment of the patient's own original knee- alternative alignment. Studies looking at alternative alignment have not shown any loss of satisfaction with results of TKR and indeed are showing some signs that in the short term, function of the knee may be better with the new technique.

The research team are planning to run a study comparing the knee replacement used in Exeter- the Triathlon- when put in place using traditional alignment versus using the alternative alignment methods. The outcomes will be assessed in various ways including patient satisfaction questionnaires, measuring muscle strength, flexibility around the knee, and by assessments of alignment of the new knee on X-rays and Computerised Tomography scans. The research team will look at short term results for satisfaction and function of the knee, and in the long term look at wear and survivorship to see if patient satisfaction with TKR can be improved.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Alternative alignment clinical study: study protocol for a prospective, randomised, controlled study of the outcomes and cost effectiveness of triathlon CR knee replacement system: traditional philosophy versus alternative alignment philosophy.
   Sheen J, Abdul W, Corroon C, Waterson B, et al · · 2025 · PMID 41351159 · DOI 10.1186/s13018-025-06551-z