Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
200 participants
INTERVENTIONAL
2023-04-01
2027-11-01
Brief Summary
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The main aim of the study is to compare changes in joint awareness (measured by the Forgotten Joint Score.
Participants who are listed for knee arthroplasty are randomised to either robotic arm assisted surgery or manual surgery.
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Detailed Description
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Robotic Assisted Surgery in total knee replacement versus Manual Total Knee Arthroplasty: A randomised controlled trial
Type of study:
CE marked device study
Trial Design:
Multi-center site prospective parallel group randomised controlled trial
Trial Participants:
Listed for routine primary total knee replacements
Investigational Device:
MAKO Robotic Arm Assisted Surgical System
Control:
Conventional jig-based surgery
Implant (Intervention and Control):
Triathlon TKR
Planned Sample Size:
200 (100 MAKO, 100 Manual)
Follow-up duration:
24 months following surgery
Planned Trial Period:
Nov 2022 - 2024
Primary Objective:
To compare changes in joint awareness (measured by the Forgotten Joint Score (FJS)20) from baseline to 12 months following TKR between the two groups.
Secondary Objectives
1. To compare pain measured using the pain visual analogue scale.
2. To compare the health-related quality of life using the EQ5D-3L at baseline, 3, 12 and 24 months.
3. To compare changes in knee function in activities of daily living (measured by the Oxford knee score (OKS)19) from baseline to 3, 12 and 24 months.
4. To compare changes in clinically assessed pain and stiffness (measured by the Knee Society Score (KSS)) at baseline to 3 and 12 months.
5. To compare revision rate using implant migration measured by CTMA at 12 and 24 months as a surrogate marker for revision.
Primary Endpoint:
Functional outcome measured by the changes in joint awareness of the FJS score at 12 months following the intervention.
Secondary Endpoints:
Secondary outcomes will be collected up to 24 months following the intervention.
Device Name:
Both arms will receive Triathlon TKR with a highly crossed linked (X3) cruciate retaining polyethylene insert.
The intervention group will utilise the MAKO robotic arm to make the bone cuts.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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MAKO TKA
Triathlon
Total knee arthroplasty
Conventional
Triathlon
Total knee arthroplasty
Interventions
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Triathlon
Total knee arthroplasty
Eligibility Criteria
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Inclusion Criteria
* Suitable candidate for a cruciate retaining TKR (Triathlon prosthesis)
* Male or Female, aged 18 years or above (18-80 at the time of listing for surgery).
* Able to understand and provide written consent.
Exclusion Criteria
* Patient is unable to comply with the study protocol (incl. refusal for CT scan)
* Female participant who is pregnant, lactating or planning pregnancy during the course of the study.
* Requires patella resurfacing
* Inability to understand the patient information for the study, provide written informed consent or answer study questionnaires for cognitive or language reasons
* Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
18 Years
80 Years
ALL
No
Sponsors
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Stryker Nordic
INDUSTRY
Sahlgrenska University Hospital
OTHER
Responsible Party
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Maziar Mohaddes Ardebili
Associate Professor
Locations
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Sahlgrenska University hospital
Gothenburg, , Sweden
Örebro University Hospital, Department of Medical Sciences
Örebro, , Sweden
Countries
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Facility Contacts
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Other Identifiers
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RAKER
Identifier Type: -
Identifier Source: org_study_id
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