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ACTIVE NOT RECRUITING

NCT03196011

Traditional Versus Alternative Alignment in TKR

Sponsor: Royal Devon and Exeter NHS Foundation Trust

View on ClinicalTrials.gov

Summary

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.

Official title: A Prospective, Randomised, Controlled Study of the Outcomes and Cost Effectiveness of Triathlon CR Knee Replacement System: Traditional Technique Versus Alternative Alignment Method.

Key Details

Gender

All

Age Range

60 Years - 120 Years

Study Type

INTERVENTIONAL

Enrollment

126

Start Date

2018-10-23

Completion Date

2025-12-31

Last Updated

2025-01-30

Healthy Volunteers

Yes

Conditions

Osteo Arthritis Knee

Interventions

OTHER

TKR with mechanical alignment method

TKR implanted using traditional mechanical alignment methods

OTHER

TKR with alternative alignment method

TKR implanted using alternative alignment methods

Inclusion Criteria:• Patients undergoing primary TKR at the RD+E Hospital * Patients must have completed a consent form for the study * Patients must be prepared to comply with the pre and post-operative investigations, rehabilitation, attendance schedule and questionnaire schedule of the study * Patient in whom any varus deformity present is \<20° * The diagnosis is of tricompartmental osteoarthritis of the knee * Patient has primary diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD). * BMI\<40 * Aged =/\> 60 years at time of surgery Exclusion Criteria:• Refusal to consent to the study * If the knee for surgery has a fixed flexion deformity ≥15°- this will be assessed by a lateral "heel-hang" x-ray of the knee for surgery * If the knee for surgery has a varus deformity ≥20° * If the knee for surgery has a valgus deformity i.e. hip/knee/ankle alignment angle \<0° * Pre-op Oxford Knee Score \<8 * Pre-op knee flexion ability \<90° * If the natural posterior tibial slope measured is in excess of 10° * Any patient whose post-operative recovery or ability to comply with the post-operative rehabilitation and assessment schedules is compromised by known existing other medical conditions * Pregnancy * Prisoners * A patient known to have substance abuse or psychological disorders that could interfere with their ability to comply with the post-operative rehabilitation and assessment schedules * Patients unable to read or understand the patient information leaflet and consent form * Patient has a known sensitivity to device materials. * Patient has a Body Mass Index (BMI) ≥ 40. * Patient has an active or suspected latent infection in or about the affected knee joint at time of study device implantation. * Patient has received any orthopaedic surgical intervention to the lower extremities within the past year or is expected to require any orthopaedic surgical intervention to the lower extremities, other than the TKR to be enrolled in this study, within the next year. * Patient requires bilateral total knee replacements, or has a history of unsuccessful contralateral partial or total knee replacement. * Patient has chronic heart failure (NYHA Stage ≥ 2) * Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device. * Patient is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's disease) leading to progressive bone deterioration. * Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. \> 30 days). * Patient requires revision surgery of a previously implanted total knee replacement or knee fusion to the affected joint.

Locations (1)

Royal Devon and Exeter Hospital

Exeter, Devon, United Kingdom