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RecruitingNCT05842538Updated Oct 10, 2023

Robotic Assisted Surgery In Total Knee Replacement

An interventional study of Triathlon in Knee Osteoarthritis, sponsored by Sahlgrenska University Hospital. Recruiting at 2 sites in Sweden. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-10-10.

Sponsored by Sahlgrenska University Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Nov 2025, 11 months ago, but the record still lists the study as recruiting.
  • Started Apr 2023; still recruiting 3 years 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

The goal of this clinical trial is to compare robotic arm assisted surgery with manual surgery in patients operated with knee replacement.

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.

Read the detailed description

Study Title:

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.

02

Conditions studied

  • Knee Osteoarthritis
03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's planned enrollment of 200 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

Sahlgrenska University Hospital is the lead sponsor of 259 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Listed for elective primary TKR for end stage osteoarthritis
  • 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

Exclusion Criteria:

  • Varus deformity of > 20 degrees observed by consultant on examination
  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    MAKO TKA

    Device: Triathlon

  • Active comparator
    Conventional

    Device: Triathlon

Interventions

  • DeviceTriathlon

    Total knee arthroplasty

06

What researchers measure

Primary outcomes

  1. Forgotten Joint Score

    Patient-reported outcome

    Time frame: 1 year

Secondary outcomes

  1. Knee pain

    Patient-reported outcome

    Time frame: 2 years

  2. EQ-5D

    Patient-reported outcome

    Time frame: 3, 12, 24 months

  3. Oxford Knee Score

    Patient-reported outcome

    Time frame: 3, 12, 24 months

  4. Knee Society Score

    Physician-reported outcome

    Time frame: 3, 12, 24 months

07

Study locations

2 of 2 sites recruiting
  • Sahlgrenska University hospital
    Gothenburg, Sweden
    • Maziar Mohaddes, Associate Professor, MD · Contact · mazmo1@vgregion.se · 0046313421000
    • Mazaíar Mohaddes, Assoc Professor, MD · Principal investigator
    Recruiting
  • Örebro University Hospital, Department of Medical Sciences
    Örebro, 705 85, Sweden
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 10, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05842538
Lead sponsor
Sahlgrenska University Hospital
Collaborators
Stryker Nordic
Responsible party
Maziar Mohaddes Ardebili (Associate Professor, Sahlgrenska University Hospital) — Principal investigator
First posted
May 6, 2023
Start date
Apr 1, 2023
Primary completion
Nov 1, 2025 (estimated)
Completion
Nov 1, 2027 (estimated)
Last update
Oct 10, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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