Bespoke vs Standard Instrumentation in TKR

NCT ID: NCT02845206

Last Updated: 2024-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 172 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-01
• Study Completion Date: 2020-02-02

Brief Summary

Total knee replacement (TKR) is an established treatment for knee osteoarthritis and leads to a satisfactory outcome in over 75% of patients. The pain and function after TKR can be dependent on the accuracy of initial implantation, as deviation of more than 3 degrees from the normal alignment of the limb can lead to abnormal stresses on the implant and accelerated failure. Patient specific cutting blocks may result in a more individualised implant placement, improved pain and function following surgery, and a long-lasting implant.

This trial is designed to investigate if there is any benefit to bespoke instrumentation in terms of pain and function to the patient, and an economic benefit to the NHS.

Detailed Description

Total knee replacement (TKR) is an established treatment for 'wear and tear' arthritis and leads to a satisfactory outcome in over 75% of patients. However, this means that up to 25% of patients are not entirely satisfied with their TKR. The longevity and stability of a TKR is greatly dependent on the accuracy of the initial surgery. Deviation of more than 3 degrees from the normal axis can lead to abnormal stresses causing the implants to fail. 'Patient specific' technology involves preoperative computer assessment of the patients' knee and allows for a 'patient specific' cutting block to be manufactured. This will allow for individual bony cuts specific to the patients own anatomy.

'Patient specific' implants and cutting blocks may allow a more optimal implant positioning and are implanted without the need for instrumentation of the femoral medullary canal (thigh), so lower blood loss may result. This could result in improved early range of movement and decreased pain following surgery. The total knee replacement used in this study will be the GMKSphere (Medacta International) TKR. It has a specific design which more closely resembles a natural unreplaced knee than any other knee replacement. It may help address the phenomenon of 'mid flexion instability', which is where the patient perceives their replaced knee to be unsteady on stairs and slopes.

Patient specific technology may also result in a cost saving, as it potentially reduces the number of sterilised trays required during the surgery.

This study will allow for comparison in knee function and patient outcomes between patients who have undergone their TKR with patient specific cutting blocks compared to conventional cutting blocks. The scans obtained following the surgery could lead to world leading methodology for the assessment of knee replacements and would set a blue print for the evaluation of other knee implants in the future.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Patient Specific Cutting Blocks

For the bespoke individualised cutting blocks to be manufactured, the patients will undergo a preoperative CT scan under a set protocol. The CT radiation dose will be considerably less than a conventional diagnostic CT scan.

Group Type: EXPERIMENTAL

Patient specific cutting blocks

Intervention Type: PROCEDURE

'MyKnee' Instrumentation

Conventional Cutting Blocks

The patients in this arm will be operated on using conventional instruments.

Group Type: ACTIVE_COMPARATOR

Conventional cutting blocks

Intervention Type: PROCEDURE

Standard Instrumentation

Interventions

Patient specific cutting blocks

'MyKnee' Instrumentation

Intervention Type: PROCEDURE

Conventional cutting blocks

Standard Instrumentation

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients with osteoarthritis ('wear and tear') of the knee which is sufficiently symptomatic to require knee arthroplasty as assessed by their consultant orthopaedic surgeon

Exclusion Criteria

• Patients with inflammatory arthropathy, patients requiring bone augmentation, ligament incompetence, values deformity > 5 degrees

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NHS Lothian

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leela C Biant, FRCSEd(Tr&Orth) MSres MFSTEd

Role: PRINCIPAL_INVESTIGATOR

University of Edinburgh

Locations

Royal Infirmary of Edinburgh

Edinburgh, Lothian, United Kingdom

Countries

United Kingdom

Other Identifiers

15/SS/0058

Identifier Type: -

Identifier Source: org_study_id