Health TrialsbyHealthPanel

Robotic Assisted vs Custom Made Total Knee Arthroplasty

ConditionKnee Osteoarthritis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-90
SponsorAustrian Workers Compensation Board Styria

About this trial

The goal of this clinical trial is to compare Robotic Assisted, functionally aligned vs Custom Made Total Knee Arthroplasty in patients with knee osteoarthritis. The main questions it aims to answer are:

* Which implant/philosophy yields better clinical outcomes? * Which implant/philosophy yields better satisfaction? * Which system is more OR efficient? Participants will be followed for 2 years postoperatively.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

- The patient is a male or non-pregnant female between the ages of 40 and 90 years

The patient requires a primary total knee replacement

Patient is deemed appropriate for a cruciate retaining knee replacement

The patient has a primary diagnosis of osteoarthritis (OA)

Disqualifiers

- The patient has a history of total, unicompartmental reconstruction or fusion of the affected joint

Patient has had a previous osteotomy around the knee

The patient is morbidly obese (BMI > 41)

The patient has a deformity which will require the use of stems, wedges or augments

Trial design

Design model

Parallel

Treatments tested in this trial

  • Custom made Total Knee Arthroplasty

    Device

    Total knee replacement, patient specific custom made total knee Origin (Symbios, Symbios Orthopédie SA, Avenue des Sciences 1, 1400 Yverdon-les-Bains, Switzerland)

  • Functionally aligned robotically assisted total knee arthroplasty

    Device

    Total knee replacement, Total Knee Implant Triathlon (Stryker, Kalamazoo, Michigan, U.S.) implanted using MAKO Rio Robotic Arm (Stryker), using functional alignment strategy

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Custom made Total Knee ArthroplastyExperimental treatment 1 intervention
Group B: Functionally aligned robotically assisted total knee arthroplastyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Clinical Outcome using the Forgotten Joint Score

Scale 0-100, higher score means better outcome

Time frame
6 weeks, 3 months, 6 months, 12 months, 24 months

Secondary outcomes

1

Clinical outcomes using the Kujala anterior knee pain Score

Scale 0-100, higher score means better outcome

Time frame
preoperatively, 6 weeks, 3 months, 6 months, 12 months, 24 months
2

Patient satisfaction

Question "Are you satisfied with the outcome of your operation" using a Likert scale with 5 points: 1- very dissatisfied, 2-dissatisfied, 3 - neither satisfied nor dissatisfied, 4 - satisfied, 5 - very satisfied

Time frame
preoperatively, 6 weeks, 3 months, 6 months, 12 months, 24 months
3

Visual analog pain (VAS) scale

Scale 0-10, higher score means better outcome

Time frame
preoperatively, 6 weeks, 3 months, 6 months, 12 months, 24 months
4

Surgical and total theatre time

Time frame
Perioperative phase

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Austrian Workers Compensation Board Styria

Lead sponsor

Source ClinicalTrials.gov
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