Randomised Control Trial of Patient Specific Instrumentation vs Standard Instrumentation of the GMK-Sphere (Global Medacta Knee) Total Knee Arthroplasty
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 172
- Locations
- 1
- Primary Endpoint
- Change from Baseline Gait Kinematics at 1-Year
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with osteoarthritis 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, patients with ligament incompetence or valgus deformity >5 degrees.
Arms & Interventions
Patient specific instrumentation
Total knee replacement with patient specific instrumentation
Intervention: Patient specific instrumentation (Device)
Patient specific instrumentation
Total knee replacement with patient specific instrumentation
Intervention: Patient specific instrumentation (Procedure)
Conventional
Total knee replacement with conventional instrumentation
Intervention: Conventional (Procedure)
Outcomes
Primary Outcomes
Change from Baseline Gait Kinematics at 1-Year
Time Frame: 1 year post-operatively
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.
Secondary Outcomes
- Patient Satisfaction (Pain/Hospital experience/functional ability/Surgery expectations)(1 year post-operatively)
- EuroQol-5 Dimensions (EQ-5D) (Patient reported outcome measure of patients' perception of their overall health)(6 weeks post-operatively)
- Knee range of motion(1 year post-operatively)
- EuroQol-5 Dimensions (EQ-5D) (Patient reported outcome measure of patients'(1 year post-operatively)
- Oxford Knee Score (Patient reported outcome measure of pain and function)(1 year post-operatively)
- Short Form-12 (SF-12) (Patient reported outcome measure of general quality of life)(1 year post-operatively)
- Oxford Knee Score (Patient reported outcome measure of pain and function)(6 weeks post-operatively)
- Short Form-12 (SF-12) (Patient reported outcome measure of general quality of life)(6 weeks post-operatively)
- Knee range of motion(6 weeks post-operatively)