Clinical and Radiological Outcomes of Medacta Shoulder System

• Sponsor: Medacta International SA (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT03547947
• Collaborator: (none)
• Enrollment: 200
• Locations: 6
• Anticipated Duration (Months): 153.6
• Patients Per Site: 33.3
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

This is a post-marketing surveillance on Medacta Shoulder System

Condition or Disease	Intervention/Treatment	Phase
Primary Osteoarthritis; Secondary Osteoarthritis; Rotator Cuff Tear Arthropathy; Rheumatoid Arthritis Shoulder; Avascular Necrosis; Fracture; Revision of Shoulder Arthroplasty	Device: Medacta Shoulder System

Study Design

• Study Type: Observational
• Anticipated Enrollment: 200 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Clinical and Radiological Outcomes of Medacta Shoulder System
• Actual Study Start Date: Jun 13, 2018
• Anticipated Primary Completion Date: Apr 1, 2031
• Anticipated Study Completion Date: Apr 1, 2031

Outcome Measures

Primary Outcome Measures

1. Survival rate [10 years]

   Kaplan Meier method

Secondary Outcome Measures

1. Clinical outcome [1, 2, 5 and 10 years]

   Constant & Murley Score

2. Functional outcome [1, 2, 5 and 10 years]

   Oxford Shoulder Score

3. Radiographic performance of the implants [3 months, 1, 2, 5 and 10 years]

   presence of radiolucencies

4. Quality of life [1, 2, 5 and 10 years]

   EQ-5D

5. Adverse events [up to 10 years]

   record of adverse event

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients older than 18 years

• Patient with one of the following diagnosis:

Primary osteoarthritis Secondary osteoarthritis Cuff tear arthropathy; insufficient rotator cuff Acute fracture (<21d) Rheumatoid or inflammatory arthritis Avascular necrosis Other posttraumatic condition Revision of shoulder arthroplasty

Exclusion Criteria:

• Patients with malignant diseases (at the time of surgery)

• Patients with proven or suspect infections (at the time of surgery)

• Patients with functional deficits other than dysfunction of the shoulder (at the time of surgery)

• Patients with known incompatibility or allergy to products materials (at the time of surgery)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinique du Sport et de Chirurgie Orthopédique	Marcq-en-Barœul		France
2	Klinik und Poliklinik für Orthopädie, Physikalische Medizin und Rehabilitation	München		Germany
3	Orthopädie Sonnenhof	Bern		Switzerland	3006
4	Inselspital	Bern		Switzerland
5	Lindenhofspital	Bern		Switzerland
6	Klinik für Orthopädische Chirurgie und Traumatologie des Bewegungsapparates, Kantonsspital St.Gallen,	Saint Gallen		Switzerland

Sponsors and Collaborators

• Medacta International SA

Investigators

• Principal Investigator: Matthias Zumstein, Prof Dr. Med, University Hospital Inselspital, Berne

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medacta International SA
• ClinicalTrials.gov Identifier: NCT03547947
• Other Study ID Numbers: P06.001.01
• First Posted: Jun 6, 2018
• Last Update Posted: Sep 2, 2020
• Last Verified: Sep 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Osteoarthritis; Rotator Cuff Tear Arthropathy; Necrosis; Rotator Cuff Injuries

Study Results

No Results Posted as of Sep 2, 2020