Open-label, Prospective, Multicenter, Post-market Study to Evaluate the Reverse Medacta Shoulder System of Total Shoulder Prosthesis.

NCT04431973 | Active Not Recruiting

• 2 other identifiers: DR190289-MSS2019-A03228-49
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 5

Brief Summary

The goal of this study is to evaluate the performance of the Medacta Shoulder System total reverse shoulder prosthesis, at 2 years of follow up, in patients who required this prosthesis for primary omarthrosis, cuff tear arthropathy, massive cuff tear or post instability arthropathy. The main goal is to evaluate at 2 years post-operatively the shoulder function of patients. The secondary goals are to assess the rate of complications, the survival rate of Reverse Medacta Shoulder System, the positioning of the prosthesis,pthe behaviour of the bone in contact with the humeral stem, Patient satisfaction and evolution of shoulder function in patients at 3 months and 1 year post-surgery.

Conditions

Shoulder Prosthesis

Outcome Measures

Primary Outcomes (1)

• Shoulder function by evaluation of Constant's Score

  The main evaluation criteria is the rate of improvement of the Constant Score and preoperative and postoperative mobility (active external and internal rotation, elbow to body) at 2 years post surgery.

  2 years post surgery

Secondary Outcomes (7)

• Complication rate

  At 2 years post surgery

• Survival implants

  At 2 years post surgery

• Position of the prosthesis

  At 3 months, 1 year and 2 years post-surgery.

• Bone behaviour

  At 3 months, 1 year and 2 years post-surgery.

• Subjective Shoulder Value

  At 3 months, 1 year and 2 years post-surgery

Study Arms (1)

Shoulder prothesis

EXPERIMENTAL

Evaluate the performance of the Medacta Shoulder System total reverse shoulder prothesis

Device: Medacta Shoulder System

Interventions

Medacta Shoulder System DEVICE

Surgical placement of the Medacta Shoulder System prothesis on patients with pathologies requiring the insertion of a total reverse shoulder prothesis for primary omarthrosis, cuff tear arthropathy, massive cuff rupture or post instability arthropathy

Shoulder prothesis

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient aged 18 to 87 ;
• Patient with one of the following diseases: primary omarthrosis, cuff tear arthropathy, massive cuff tear or post instability arthropathy;
• Patient in need of a total shoulder prosthesis;
• Patient affiliated with or beneficiary of a social security scheme;
• Patient who has given written informed consent for the study.

You may not qualify if:

• Patient with malignant diseases;
• Patient with known or suspected infections;
• Patient with neurological deficits that may affect shoulder function;
• Patient with known incompatibility or allergy to product materials;
• Patient with previous open shoulder surgery (fracture sequelae, plate or nail, revision ...), treated for fractures, or suffering from rheumatoid arthritis (this does not concern patients treated by arthroscopy, or bone block);
• Protected major patient;
• Vulnerable person according to article L1121-6 of the Public Health Code;
• Pregnant or breastfeeding woman or woman of childbearing age;
• Impossibility to follow the consultation schedule planned in the study (planned move or mutation, etc...).
• Patient with malignant diseases on the day of surgery;
• Patient with known incompatibility or allergy to product materials on the day of surgery;
• Patient with known or suspected infections on the day of surgery.

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (5)

Chu Angers

Angers, France

Location

Chu Rennes

Rennes, France

Location

Clinique Mutualiste la Sagesse

Rennes, France

Location

Polyclinique santé atlantique

Saint-Herblain, France

Location

Chu Tours

Tours, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2020
• First Posted: June 16, 2020
• Study Start: September 1, 2020
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: November 24, 2025

Record last verified: 2025-11

Locations

FR (5)