Clinical trial NCT05935878: Cemented Versus Cementless Unicompartmental Knee Arthroplasty
Official title: Cemented Versus Cementless Unicompartmental Knee Arthroplasty (UKA) - A Single-blind Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: Knee Arthroplasty
Unicompartmental
Fixation
Radiostereometric Analysis
Lead sponsor: Oxford University Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2023-07-07
Enrollment: 47
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomised to receive either a cementless or cemented Oxford Unicompartmental Knee Arthroplasty.
Primary purpose: TREATMENT

Brief 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.

Detailed description: Design: A prospective, randomised trial to compare the outcome of cemented and cementless unicompartmental knee replacement.

Size: 40 subjects in total will be recruited with 20 in each arm.

Methods: Patients will be recruited from the routine waiting list for unicompartmental knee replacement at the Nuffield Orthopaedic Centre. All subjects will have the procedure explained and be fully consented prior to the procedure.

Randomisation: Patients will be randomly allocated to receive either a cemented or cementless Oxford Unicompartmental Knee Replacement. This will be performed using a randomisation program based on optimisation (Minim). Subjects will be stratified according to sex and age.

Operation: All subjects will undergo the same surgical approach. 0.8mm Tantalum marker balls will be placed at standardised sites on the femur and tibia in all cases. All cemented components will be secured using the same cement. Cementless components have a hydroxy-appatite coating to facilitate bone ingrowth.

Follow-up: All patients will be followed up at 0, 3, 6, 12, 24, 60, and 120 months with clinical and radiological assessment. Clinical assessment will involve documentation with the Oxford Knee Score. Patients will undergo radiostereometric analysis and fluoroscopy to study implant migration and occurence of radiolucency, respectively.

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.

Primary outcomes:
measure: Radiostereometric Analysis Examination - Translations
timeFrame: Patients will be examined 3 months post surgery.
measure: Radiostereometric Analysis Examination - Translations
timeFrame: Patients will be examined 6 months post surgery.
measure: Radiostereometric Analysis Examination - Translations
timeFrame: Patients will be examined 12 months post surgery.
measure: Radiostereometric Analysis Examination - Translations
timeFrame: Patients will be examined 24 months post surgery.
measure: Radiostereometric Analysis Examination - Translations
timeFrame: Patients will be examined 60 months post surgery.
measure: Radiostereometric Analysis Examination - Translations
timeFrame: Patients will be examined 120 months post surgery.
measure: Radiostereometric Analysis Examination - Rotations
timeFrame: Patients will be examined at 3 months post surgery.
measure: Radiostereometric Analysis Examination - Rotations
timeFrame: Patients will be examined at 6 months post surgery.
measure: Radiostereometric Analysis Examination - Rotations
timeFrame: Patients will be examined at 12 months post surgery.
measure: Radiostereometric Analysis Examination - Rotations
timeFrame: Patients will be examined at 24 months post surgery.
measure: Radiostereometric Analysis Examination - Rotations
timeFrame: Patients will be examined at 60 months post surgery.
measure: Radiostereometric Analysis Examination - Rotations
timeFrame: Patients will be examined at 120 months post surgery.
measure: Radiostereometric Analysis Examination - Maximum Total Point Motion
timeFrame: Patients will be examined at 3 months post surgery.
measure: Radiostereometric Analysis Examination - Maximum Total Point Motion
timeFrame: Patients will be examined at 12 months post surgery.
measure: Radiostereometric Analysis Examination - Maximum Total Point Motion
timeFrame: Patients will be examined at 24 months post surgery.
measure: Radiostereometric Analysis Examination - Maximum Total Point Motion
timeFrame: Patients will be examined at 60 months post surgery.
measure: Radiostereometric Analysis Examination - Maximum Total Point Motion
timeFrame: Patients will be examined at 120 months post surgery.
measure: Radiographic Examination
timeFrame: Patients will be examined at 12 months post surgery.
measure: Radiographic Examination
timeFrame: Patients will be examined at 24 months post surgery.
measure: Radiographic Examination
timeFrame: Patients will be examined at 60 months post surgery.
measure: Radiographic Examination
timeFrame: Patients will be examined at 120 months post surgery.
measure: Clinical Assessment
timeFrame: Patients will be assessed pre-operatively.
measure: Clinical Assessment
timeFrame: Patients will be assessed at 12 months post surgery.
measure: Clinical Assessment
timeFrame: Patients will be assessed at 24 months post surgery.
measure: Clinical Assessment
timeFrame: Patients will be assessed at 60 months post surgery.
measure: Clinical Assessment
timeFrame: Patients will be assessed at 120 months post surgery.
measure: Radiostereometric Analysis Examination - Maximum Total Point Motion
timeFrame: Patients will be assessed at 6 months post surgery.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Oxford
name: David W Murray, MA, MD, FRCS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kendrick BJ, Kaptein BL, Valstar ER, Gill HS, Jackson WF, Dodd CA, Price AJ, Murray DW. Cemented versus cementless Oxford unicompartmental knee arthroplasty using radiostereometric analysis: a randomised controlled trial. Bone Joint J. 2015 Feb;97-B(2):185-91. doi: 10.1302/0301-620X.97B2.34331.
citation: Campi S, Kendrick BJL, Kaptein BL, Valstar ER, Jackson WFM, Dodd CAF, Price AJ, Murray DW. Five-year results of a randomised controlled trial comparing cemented and cementless Oxford unicompartmental knee replacement using radiostereometric analysis. Knee. 2021 Jan;28:383-390. doi: 10.1016/j.knee.2020.09.003. Epub 2021 Jan 4.