Total Versus Robotic Assisted Unicompartmental Knee Replacement

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-75
SponsorNHS Lothian

About this trial

The purpose of this research is to compare the functional outcomes of patients with end stage medial compartment OA of the knee undergoing a conventional mTKA to those undergoing rUKA and to assess the associated cost economics of such technology.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Listed for elective primary TKA for end stage medial compartment osteoarthritis

Intact anterior cruciate ligament

Full thickness and good quality lateral cartilage

Correctable intra-articular varus deformity and intact medial collateral ligament

Disqualifiers

Varus deformity of > 20 degrees

Fixed flexion of >10 degrees

Patient is unable to comply with the study protocol (incl. refusal for CT scan) or functional assessments

Female participants who are pregnant, lactating or planning pregnancy during the course of the study

Trial design

Design model

Parallel

Treatments tested in this trial

  • MAKO™ Partial Knee Arthroplasty

    Device

    The robotic-arm will be used to position a partial knee arthroplasty.

  • Triathlon (Stryker) Total Knee Arthroplasty

    Device

    Triathlon (Stryker) TKA with a cruciate retaining polyethylene insert.

Treatment groups

159 Participants
are divided into 2 treatment groups
Group A: Manual Total Knee ArthroplastyActive comparator 1 intervention
Group B: Robotic Assisted Unicompartmental Knee ArthroplastyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Oxford knee score

Knee specific functional outcome measure. It consists of twelve questions assessed on a Likert scale with values from 0 to 4, to give a summative score. This is measured on a scale from 0 (worst) to 48 (best).

Time frame
Baseline to 6 months

Secondary outcomes

1

Oxford knee score and Activity and Participation Questionnaire

The Oxford knee score is a knee specific functional outcome measure. It consists of twelve questions assessed on a Likert scale with values from 0 to 4, to give a summative score. This is measured on a scale from 0 (worst) to 48 (best). The additional Activity and Participation Questionnaire is a higher functioning supplementary questionnaire consisting of a further eight questions scored 0 (worst) to 4 (best).

Time frame
Baseline to 3, 6 and 12 months
2

Forgotten Joint Score

Knee specific functional outcome. It uses a five-point Likert response format, consisting of 12 equally weighted questions with the raw score transformed to range from zero (worst) to 100 (best) points.

Time frame
Baseline to 3, 6 and 12 months
3

Patient satisfaction

Patient satisfaction will be assessed following surgery by asking four questions with a different focus: i. "Overall how satisfied are you with the results of your knee replacement surgery?" ii. "How satisfied are you with the results of your knee replacement surgery for improving your ability to do housework or yard work (such as cooking, cleaning, or gardening and raking leaves)?" iii. "How satisfied are you with the results of your knee replacement surgery for improving your ability to do recreational activities (such as taking walks, swimming, bicycling, playing golf, dancing, going out with friends)?" iv. "How satisfied are you with the results of your knee replacement surgery for relieving your pain?" The response to each question will be recorded using a four point Likert scale: very satisfied, somewhat satisfied, somewhat dissatisfied, and very dissatisfied.

Time frame
3, 6 and 12 months
4

EQ-5D-3L

Quality of life will be assessed using the EQ-5D-3L general health questionnaire which evaluates five domains (-5D), which include: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. This is a two page questionnaire that consists of five dimensions, with the responses recorded at three levels (3L) of severity (no problems; some problems or extreme problems). The utility index is on a scale of -0.594 to 1, where 1 represents perfect health and a negative value represents a state perceived as worse than death. The second page consists of a standard vertical 20cm visual analogue scale (EQ-5D VAS) which is transformed to a scale of 0 (worst) to 100 (best) measuring current health-related quality of life. Each patient's health state, derived from the EQ-5D, will be measured before and after their surgery to determine the change in their health gain or loss after their knee replacement surgery.

Time frame
Baseline to 3, 6 and 12 months

Other outcomes

Sponsors and contacts

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