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Kinematic Alignment Compared to Mechanical Alignment Techniques for Total Knee Replacement Surgery (KARMA)

NCT03994250 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2021-04-01

No results posted yet for this study

Summary

Total knee replacement (TKR) is a bony and soft-tissue procedure and much attention has been given to the alignment of the components, which is relatively easy to quantify. Recently, substantial healthcare resources have been devoted to the development and use of computer navigation and patient-specific instrumentation systems that achieve neutral mechanical alignment. However the conventional assumption that mechanically aligned TKR leads to the best implant survival has been brought into doubt. Although mechanically aligned TKR improves function, 20 % of patients remain dissatisfied according to reports from Canada, England and Wales.

In an attempt to improve patient satisfaction recent developments have included the individualization of component alignment with the goal of achieving pre-arthritic alignment through restoration of the axes of rotation, a technique called kinematic alignment (KA). The outcomes of kinematic alignment have been assessed in case series but so far only one randomised controlled trial (RCT) \[Digital Object Identifier (DOI)10.1302/0301-620X.96B7.32812 Published 1 July 2014\] undertaken in the USA has compared the clinical results of kinematic alignment using patient-specific instruments with the traditional technique of mechanical alignment, demonstrating a substantial benefit in postoperative patient pain relief and function. Therefore, for direct comparison between kinematic aligned and mechanically aligned surgical techniques for total knee replacement, the investigators would like to undertake a pilot study prior to a larger RCT and recruit a cohort of 15 patients undergoing kinematical aligned TKR. The investigators will use the same device as was used in a previous mechanically aligned study undertaken at our hospital (REC ref: 12/NE/0293 Attune, DePuy, Warsaw IN, in 35 patients based on the same eligibility criteria who will act as controls), which will allow the opportunity to estimate the standard deviation in the control arm in preparation for the larger RCT.

Conditions

  • Osteo Arthritis Knee

Interventions

OTHER

Kinematic Alignment for total knee replacement surgery

Using Kinematic Alignment for total knee replacement surgery

OTHER

Mechanical Alignment for total knee replacement surgery

Using mechanical alignment for total knee replacement surgery

Sponsors & Collaborators

  • Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust

    lead OTHER_GOV

Principal Investigators

  • JP Whittaker, FRCS · Consultant Orthopaedic Surgeon

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
22 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-10
Primary Completion
2021-01-01
Completion
2021-01-01

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03994250 on ClinicalTrials.gov