N/A N=47 Randomized Single-blind Treatment

Cemented Versus Cementless Unicompartmental Knee Arthroplasty

Osteoarthritis, Knee

Bottom Line

View on ClinicalTrials.gov: NCT05935878 ↗

Enrolled (actual)

Serious AEs

4.3%

Results posted

Feb 2024

Primary outcome: Primary: Radiostereometric Analysis Examination - Translations — -0.01; 0.05; -0.10; -0.17 millimetres

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Cementless Oxford Unicompartmental Knee Arthroplasty (Device); Cemented Oxford Unicompartmental Knee Arthroplasty (Device)
Age: Adult, Older Adult · 30+ yrs
Sex: All
Sponsor: Oxford University Hospitals NHS Trust
Primary completion: Mar 2022

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 - Translations	-0.12; 0.24; -0.14; -0.16; 0.20; 0.14	—
PRIMARY Radiostereometric Analysis Examination - Translations	-0.12; 0.24; -0.14; -0.16; 0.20; 0.14	—
PRIMARY Radiostereometric Analysis Examination - Translations	-0.12; 0.24; -0.14; -0.16; 0.20; 0.14	—
PRIMARY Radiostereometric Analysis Examination - Translations	-0.12; 0.24; -0.14; -0.16; 0.20; 0.14	—
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 - Rotations	-0.02; 0.27; 0.19; 0.38; 0.53; 0.38	—
PRIMARY Radiostereometric Analysis Examination - Rotations	-0.02; 0.27; 0.19; 0.38; 0.53; 0.38	—
PRIMARY Radiostereometric Analysis Examination - Rotations	-0.02; 0.27; 0.19; 0.38; 0.53; 0.38	—
PRIMARY Radiostereometric Analysis Examination - Rotations	-0.02; 0.27; 0.19; 0.38; 0.53; 0.38	—
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 Radiostereometric Analysis Examination - Maximum Total Point Motion	0.86; 0.80; 0.79; 0.64	—
PRIMARY Radiostereometric Analysis Examination - Maximum Total Point Motion	0.86; 0.80; 0.79; 0.64	—
PRIMARY Radiostereometric Analysis Examination - Maximum Total Point Motion	0.86; 0.80; 0.79; 0.64	—
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 Radiographic Examination	1; 6; 0; 0; 14; 8	—
PRIMARY Radiographic Examination	1; 6; 0; 0; 14; 8	—
PRIMARY Radiographic Examination	1; 6; 0; 0; 14; 8	—
PRIMARY Clinical Assessment	42; 39	—
PRIMARY Clinical Assessment	42; 39	—
PRIMARY Clinical Assessment	42; 39	—
PRIMARY Clinical Assessment	42; 39	—
PRIMARY Clinical Assessment	42; 39	—
PRIMARY Radiostereometric Analysis Examination - Maximum Total Point Motion	0.86; 0.80; 0.79; 0.64	—

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.

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.

View full record on ClinicalTrials.gov →

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.