N/A
Completed N=47
Cemented Versus Cementless Unicompartmental Knee Arthroplasty
Osteoarthritis, Knee
Source: ClinicalTrials.gov NCT05935878 ↗
Enrolled (actual)
47
Serious AEs
4.3%
Results posted
Feb 2024
Primary outcomePrimary: Radiostereometric Analysis Examination - Translations — -0.01; 0.05; -0.10; -0.17 millimetres
Summary
Unicompartmental knee replacement for selected cases of osteoarthritis is less invasive than total knee replacement. It gives better range of movement; patients stay for shorter time in the hospital and have a more natural feel than total knee replacement. Usually, the implant is fixed in the bone using bone cement. However, there are potential disadvantages of using bone cement. The operation takes longer; cement can get squeezed out into the surrounding tissues and may interfere with function. To avoid these problems, the implant can be fixed without cement. Cementless components have a special coating to encourage bone in-growth and fixation. Although the investigators believe cementless fixation will be at least as good as cemented fixation, there is a risk that it could be worse and might result in loosening.
The aim of this study is therefore to compare the outcome of cemented and cementless unicompartmental knee replacement.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Radiostereometric Analysis Examination - Translations |
-0.12; 0.24; -0.14; -0.16; 0.20; 0.14 | — |
| PRIMARY Radiostereometric Analysis Examination - Rotations |
-0.02; 0.27; 0.19; 0.38; 0.53; 0.38 | — |
| PRIMARY Radiostereometric Analysis Examination - Maximum Total Point Motion |
0.86; 0.80; 0.79; 0.64 | — |
| PRIMARY Radiographic Examination |
1; 6; 0; 0; 14; 8 | — |
| PRIMARY Clinical Assessment |
42; 39 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy Subjects with osteoarthritis of knee fulfilling the standard indications for an Oxford Unicompartmental Knee Replacement.
- American Society of Anaesthesiologists (ASA) Score of 1 to 3.
Exclusion Criteria
- Subjects with severe limiting systemic illness (i.e. ASA > 3).
- Subjects who are too large for radiostereometric analysis to be carried out.
- Subjects who have had previous open surgery or anterior cruciate ligament (ACL) reconstruction on the same knee.
Data sourced from ClinicalTrials.gov (NCT05935878). 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. Informational only — not medical advice.