Bespoke vs Standard Instrumentation in TKR

NCT02845206 | Completed DMC

• 1 other identifier: 15/SS/0058
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Keywords

Total Knee Replacement; Patient Specific Instrumentation

Outcome Measures

Primary Outcomes (1)

• Limb alignment

  Measured in degrees from Hip-Knee-Ankle radiographs from centre of femoral head to midpoint of the ankle

  1 years

Secondary Outcomes (5)

• Difference between baseline pre-op and one year post-op change in gait measured using a bespoke clinic-appropriate motion analysis system.

  1 year

• Difference in patient reported knee pain level as measured by Oxford Knee Score between baseline and one year and also between study groups.

  1 year

• Difference in patient reported knee function between baseline and one year and also between study groups.

  1 year

• Difference in patient reported quality of life questionnaires between baseline and one year and also between study groups.

  1 year

• Healthcare cost

  1 year

Study Arms (2)

Patient Specific Cutting Blocks

EXPERIMENTAL

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.

Procedure: Patient specific cutting blocks

Conventional Cutting Blocks

ACTIVE COMPARATOR

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

Procedure: Conventional cutting blocks

Interventions

Patient specific cutting blocks PROCEDURE

'MyKnee' Instrumentation

Patient Specific Cutting Blocks

Conventional cutting blocks PROCEDURE

Standard Instrumentation

Conventional Cutting Blocks

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• NHS Lothian: lead

Study Sites (1)

Royal Infirmary of Edinburgh

Edinburgh, Lothian, EH16 4SA, United Kingdom

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

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

  University of Edinburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2016
• First Posted: July 27, 2016
• Study Start: February 1, 2016
• Primary Completion: February 2, 2018
• Study Completion: February 2, 2020
• Last Updated: September 23, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)