Bespoke vs Standard Instrumentation in TKR (SPHERE)
Status
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
172 participants in 2 patient groups
Trial contacts and locations
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Central trial contact
Leela Biant; Lawrie Rogerson
Data sourced from clinicaltrials.gov
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