Bespoke vs Standard Instrumentation in TKR

NCT05579951 | Completed

• 1 other identifier: R04611
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

Brief Summary

Total knee replacements are operations that are offered to patients who have severe arthritis pain that is affecting daily activities that is no longer controlled with painkillers. The operation will replace the worn joints with metal implants and a plastic spacer. Total knee replacements are successful operations in the vast majority of patients. However, a small minority of patients are not entirely satisfied with the outcome of their knee replacement. Researchers are studying whether the precise positioning of the implant has an effect on the outcome. This study will look at whether patient-specific instrumentation improves implant position and if it leads to improved patient function so that we know what to recommend in the future.

Conditions

Knee Osteoarthritis

Keywords

Total knee arthroplasty; Stability; Osteoarthritis; Knee; Functional Outcome; Gait; Patient Specific Instrumentation

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.

  1 year post-operatively

Secondary Outcomes (9)

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

  1 year post-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)

  6 weeks post-operatively

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

  1 year post-operatively

Study Arms (2)

Conventional

ACTIVE COMPARATOR

Total knee replacement with conventional instrumentation

Procedure: Conventional

Patient specific instrumentation

ACTIVE COMPARATOR

Total knee replacement with patient specific instrumentation

Procedure: Patient specific instrumentation; Device: Patient specific instrumentation

Interventions

Patient specific instrumentation PROCEDURE

Total knee replacement with patient specific instrumentation

Patient specific instrumentation

Conventional PROCEDURE

Total knee replacement with conventional instrumentation

Conventional

Eligibility Criteria

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

You may qualify if:

• Patients with osteoarthritis 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, patients with ligament incompetence or valgus deformity \>5 degrees.

Sponsors & Collaborators

• Manchester University NHS Foundation Trust: lead
• University of Manchester: collaborator

Study Sites (1)

Trafford General Hospital

Manchester, United Kingdom

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Interventions

Congresses as Topic

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Organizations; Health Care Economics and Organizations

Study Officials

• Leela Biant

  University of Manchester

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 11, 2022
• First Posted: October 14, 2022
• Study Start: September 21, 2021
• 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)