ROSA Total Knee Post Market Study EMEA

Not Applicable

Active, not recruiting

• Conditions: Chronic Osteoarthritis; Knee Pain; Rheumatoid Arthritis; Moderate Varus, Valgus or Flexion Deformities; Avascular Necrosis of the Femoral Condyle

• Registration Number: NCT04338893
• Lead Sponsor: Zimmer Biomet

Brief Summary

This is a prospective, multicenter clinical study designed to facilitate the collection and evaluation of surgical workflow efficiency, patient pain and function outcome and adverse events data. This study might include Persona, Nexgen and Vanguard product families using the ROSA Total Knee Robotic system or conventional instrumentation. The primary objective is to evaluate the accuracy of implant alignment for ROSA Total Knee robotic instrumentation compared to conventional instrumentation.

Detailed Description

The main purpose of this study is to collect and compare clinical outcomes data using the commercially available ROSA Total Knee robotic instrumentation and conventional instrumentation. This will be achieved by assessing: planned vs actual component positioning, operative workflow efficiency, patient safety based on incidence and frequency of adverse events, clinical performance measured by overall pain and function, health-related quality of life data and radiographic parameters.

The primary endpoint will report on the accuracy of implant alignment for ROSA Total Knee robotic instrumentation compared to conventional and the secondary endpoints will record surgery time points and evaluate the change of clinical outcomes scores between baseline and post operative follow up for performance and clinical benefits

Study Timeline

• Study First Submitted: 2020-01-24
• Study First Submitted QC: 2020-04-07
• Study First Posted: 2020-04-08
• Study Start: 2020-12-15
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-05
• Last Update Posted: 2024-11-06
• Primary Completion: 2025-03
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 252

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Evaluate the accuracy of implant alignment for ROSA total knee robotic instrumentation compared to conventional instrumentation	1 year	measuring femoral rotation in the axial plane using pre and post op CT assessments

Secondary Outcome Measures

Name	Time	Method
Measure operative workflow efficiency by recording following time points during surgery	1 year	time points recorded are: patient in-and out time, incision- and incision closed time
Evaluate Health related quality of life at baseline and each post-operative follow up	1 year	EQ-5D-5L health questionnaireEuroqol-5 dimensions by the EuroQol Group consists of a descriptive system of health-related quality of life by a questionnaire and a thermometer scale. The Questionnaire comprises five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) with each 5 levels: no problems (level 1), slight problems (level 2), moderate problems, (level 3) severe problems (level 4) and extreme problems (level 5). The digits for the five dimensions can be combined into a 5-digit number and may be converted to a score (maximum is 1), defined by the health state classification.The Thermometer generates a self rating of current health-related quality of life and has end points of 100 (best imaginable health state) at the top, and 0 (worst imaginable health state) at the bottom. It should be used with the 5-digit health state classification to build a composite picture of the respondent's health status.
Evaluate knee functionality at baseline and each post-operative follow up	1 year	Objective Knee Assessment is used to assess knee functionality by the investigator with objective knee indicators (2011 The Knee Society) up to 100 points. A higher score means a better functional outcome
Evaluate patient satisfaction at baseline (first postop visit) and each post operative follow up	1 year	Patients to provide additional information regarding the level of satisfaction with the operated knee by answering 4 questions with 4 options to answer from very satisfied, satisfied, dissatisfied to very dissatisfied
Evaluate the change of the Oxford Knee Score between baseline and each post-operative follow up	1 year	Oxford Knee Score is a patient-reported form and consists of 12 questions on the influence of the knee (surgical side) on daily activities or pain. The patient scores each question (item) from 0 to 4 with 0 being the worst outcome and 4 being the best outcome. The scores are then summed to produce an overall score running from 0 (worst possible) to 48 (best outcome).
Evaluate Pain intensity at baseline and each post-operative follow up	1 year	NRS Pain (Numeric Rating Scale for Pain). NRS Pain is a numeric scale from 0 to 10 to measure pain intensity from 0 (no pain) to 10 (worst imaginable pain)
Evaluate awareness of patients affected knee joint at baseline and each post operative follow up	1 year	FJS-12 is a patient-reported form and consist of 12 questions to assess awareness of patients affected knee joint in daily activities.all responses are summed (never, 0 points; almost never, 1 point; seldom, 2 points; sometimes, 3 points; mostly, 4 points) and then divided by the number of completed items. This mean value is subsequently multiplied by 25 to obtain a total score range of 0 top 100. A high score indicate a high degree of "forgetting" the artificial joint, i.e. a lower degree of awareness.

Trial Locations

Locations (6)

Herzogin Elisabeth Hospital; 🇩🇪 Braunschweig, Germany

Evangelisches Waldkrankenhaus Spandau; 🇩🇪 Spandau, Germany

San Giuseppe Hospital; 🇮🇹 Arezzo, Italy

Cliniques Universitaires Saint-Luc; 🇧🇪 Brussels, Belgium

Hôpitaux Universitaires de Genève; 🇨🇭 Geneva, Switzerland

The Research Fund of Hadassah Medical Organization; 🇮🇱 Jerusalem, Israel