A Functional Comparison of Two TKR Designs

NCT03618771 | Completed DMC

• 1 other identifier: B00116
• Study Type: interventional
• Target: 170
• 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. However, up to 25% of patients are not entirely satisfied with their TKR. Patient dissatisfaction has been associated with inadequate functional outcome, especially during negotiation of stairs and slopes. This phenomenon, known as mid-flexion instability, is believed to be caused by excessive anterior-posterior motion of the implant during activities of daily living. This is characterised as a perception that the replaced knee is unsteady during certain tasks. This study will compare the functional outcome of two implants that have been designed to provide patients with a functionally stable knee throughout its range of motion. The different design roles in preventing implant-related mid-flexion instability remain unknown. The functional outcome and stability of these implants will be tested non-invasively with 3D motion capture technology.

Conditions

Knee Osteoarthritis

Keywords

Total Knee Arthroplasty; Osteoarthritis; Stability; Knee; Functional Outcome; Gait; Biomechanics

Outcome Measures

Primary Outcomes (1)

• Change from Baseline Gait Kinematics at 1-Year

  Gait of patients will be analysed pre-operatively, six-weeks post-operatively, and 1-year post-operatively by 3D motion capture technology. The change measured over time at 1-year will be the primary outcome.

  Change from baseline at 1-Year

Secondary Outcomes (19)

• Patient Satisfaction (Pain/Hospital experience/functional ability/Surgery expectations)

  1 year post-operatively

• Oxford Knee Score (Patient reported outcome measure of pain and function)

  Pre-operatively

• Oxford Knee Score (Patient reported outcome measure of pain and function)

  6 weeks post-operatively

• Oxford Knee Score (Patient reported outcome measure of pain and function)

  1 year post-operatively

• EuroQol-5 Dimensions (EQ-5D) (Patient reported outcome measure of patients' perception of their overall health)

  Pre-operatively

Study Arms (2)

Medacta GMK Sphere

EXPERIMENTAL

Half of the patients will be implanted with the Medacta GMK Sphere total knee arthroplasty

Device: Total knee arthroplasty

DePuy Synthes Attune

EXPERIMENTAL

Half of the patients will be implanted with the DePuy Attune total knee arthroplasty

Device: Total knee arthroplasty

Interventions

Total knee arthroplasty DEVICE

Parts of the knee joint diseased by osteoarthritis are replaced by metal and plastic prostheses.

Also known as: Medacta GMK Sphere Implant, DePuy Synthes Attune Implant

DePuy Synthes Attune; Medacta GMK Sphere

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of osteoarthritis of the knee which is sufficiently symptomatic to require knee arthroplasty as assessed by their consultant orthopaedic surgeon

You may not qualify if:

• Inflammatory arthropathy
• Patients requiring bone augmentation
• Patients with collateral ligament incompetence
• Valgus deformity \>5 degrees.

Sponsors & Collaborators

• Manchester University NHS Foundation Trust: lead
• Medacta International SA: collaborator

Study Sites (1)

Trafford General Hospital

Manchester, United Kingdom

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Leela C Biant, FRCSEd Tr & Orth

  University of Manchester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2018
• First Posted: August 7, 2018
• Study Start: February 6, 2019
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: January 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)