Clinical trial NCT05579951: Bespoke vs Standard Instrumentation in TKR
Official title: Randomised Control Trial of Patient Specific Instrumentation vs Standard Instrumentation of the GMK-Sphere (Global Medacta Knee) Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Total knee arthroplasty
Stability
Osteoarthritis
Knee
Functional Outcome
Gait
Patient Specific Instrumentation
Lead sponsor: Manchester University NHS Foundation Trust
Sponsor class: OTHER_GOV
Collaborators: name: University of Manchester
First posted: 2022-10-14
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline Gait Kinematics at 1-Year
timeFrame: 1 year post-operatively
Secondary outcomes:
measure: Patient Satisfaction (Pain/Hospital experience/functional ability/Surgery expectations)
timeFrame: 1 year post-operatively
measure: Oxford Knee Score (Patient reported outcome measure of pain and function)
timeFrame: 6 weeks post-operatively
measure: Oxford Knee Score (Patient reported outcome measure of pain and function)
timeFrame: 1 year post-operatively
measure: EuroQol-5 Dimensions (EQ-5D) (Patient reported outcome measure of patients' perception of their overall health)
timeFrame: 6 weeks post-operatively
measure: EuroQol-5 Dimensions (EQ-5D) (Patient reported outcome measure of patients'
timeFrame: 1 year post-operatively
measure: Short Form-12 (SF-12) (Patient reported outcome measure of general quality of life)
timeFrame: 6 weeks post-operatively
measure: Short Form-12 (SF-12) (Patient reported outcome measure of general quality of life)
timeFrame: 1 year post-operatively
measure: Knee range of motion
timeFrame: 6 weeks post-operatively
measure: Knee range of motion
timeFrame: 1 year post-operatively
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Trafford General Hospital
Study officials:
affiliation: University of Manchester
name: Leela Biant
role: PRINCIPAL_INVESTIGATOR
References: