A multi-centre, single-arm, prospective, pre-market, pivotal study on robotic instrumentation (ROSA® Partial Knee System) in patients undergoing medial unicompartmental knee arthroplasty

Not Applicable

• Conditions: Osteoarthritis; Partial Knee Arthroplasty; Musculoskeletal - Osteoarthritis; Surgery - Other surgery

• Registration Number: ACTRN12620001271998
• Lead Sponsor: Zimmer Biomet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-25
• Last Update Posted: 30 November 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

1) Body mass index greater than or equal to 40 kg/m2
2) Patient qualifies for primary UKA for isolated medial compartment osteoarthritis based on investigator’s clinical judgement and has an intact ACL.
3) Independent of study participation, patient is a candidate and meets the indications and contraindications for UKA of the medial compartment with the Persona® partial knee system.

Exclusion Criteria

1) Infection, Sepsis, Osteomyelitis
2) Inflammatory or Post-traumatic arthropathy, or any other degenerative joint disease not consistent with osteoarthritis.
3) Prior ACL repair.
4) Varus/Valgus deformity greater than 15 degrees.
5) Orthopaedic procedure or pain management study of any joint within the last or next 6 months

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the accuracy of implant position compared to the implemented plan in unicompartmental knee arthroplasty (UKA) performed with a robotic-arm surgical assistant. <br>This is a composite outcome of the following assessments:<br><br>Post-operative radiography: measurements of the implemented surgical plan (ROSA log data) against radiographs assessing the following:<br>1) Tibial Coronal Angle (Varus/Valgus)<br>2) Tibial Sagittal Angle (tilt/slope)<br>3) Femoral Coronal Alignment (reported as degrees from parallel to the tibial cut)<br>4) Femoral Sagittal Angle (flexion)<br>5) Thickness of tibial and femoral resection (tibia proximal and femoral distal)<br>6) Tibial Sagittal Cut (Axial Plane, intraoperative validation only)<br>7) Tibial horizontal offset from sagittal resection reference landmark<br>8) Postoperative Hip-Knee-Ankle Angle.<br><br>[3 months post-intervention procedure]