N/A
N=45
The Assessment of Patient Specific Instrumentation for Unicompartmental Knee Replacement
Knee Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT02748096 ↗Enrolled (actual)
45
Serious AEs
4.4%
Results posted
Nov 2021
Primary outcome: Primary: Radiological Assessment of Component Positioning — 0.9; 1.8; 9.1; 8.8 Degrees — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Patient Specific Instrumentation (Procedure); Conventional Instrumentation (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Oxford University Hospitals NHS Trust
- Primary completion
- Feb 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Radiological Assessment of Component Positioning |
0.9; 1.8; 9.1; 8.8; 3.5; 8.8 | <0.05 sig |
| SECONDARY Assessment of Functional Outcome |
18.3; 18.2 | <0.05 sig |
Summary
Patient-specific instrumentation guides have previously been used to improving surgical accuracy and ease of implantation during Total Knee Replacement but have received less attention for implanting Unicompartmental Knee Replacement. The aim of this prospective study is to compare the accuracy of implantation and functional outcome of mobile bearing medial Unicompartmental Knee Replacement implanted with and without patient specific instrumentation by experienced knee surgeons.
Eligibility Criteria
Inclusion Criteria
- Both cruciate ligaments functionally intact
- Full thickness cartilage in the lateral compartment
- Correctable intra-articular varus deformity
- Full thickness cartilage loss in the medial compartment
Exclusion Criteria
- Contra-indication for MRI
- All forms of inflammatory arthritis
Data sourced from ClinicalTrials.gov (NCT02748096). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.