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Clinical and Radiological Outcomes of Medacta Shoulder System

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ClinicalTrials.gov Identifier: NCT03547947
Recruitment Status : Recruiting
First Posted : June 6, 2018
Last Update Posted : June 6, 2018
Sponsor:
Information provided by (Responsible Party):
Medacta International SA

Brief Summary:
This is a post-marketing surveillance on Medacta Shoulder System

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

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical and Radiological Outcomes of Medacta Shoulder System
Estimated Study Start Date : June 2018
Estimated Primary Completion Date : April 2031
Estimated Study Completion Date : April 2031

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: Medacta Shoulder System
    Total Shoulder Arthroplasty


Primary Outcome Measures :
  1. Survival rate [ Time Frame: 10 years ]
    Kaplan Meier method


Secondary Outcome Measures :
  1. Clinical outcome [ Time Frame: 1, 2, 5 and 10 years ]
    Constant & Murley Score

  2. Functional outcome [ Time Frame: 1, 2, 5 and 10 years ]
    Oxford Shoulder Score

  3. Radiographic performance of the implants [ Time Frame: 3 months, 1, 2, 5 and 10 years ]
    presence of radiolucencies

  4. Quality of life [ Time Frame: 1, 2, 5 and 10 years ]
    EQ-5D

  5. Adverse events [ Time Frame: up to 10 years ]
    record of adverse event



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients requiring TSA and who are suitable to receive Medacta Shoulder System will be proposed to take part to the current post-marketing surveillance study during their pre-operative visit.
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03547947


Contacts
Contact: Mara Colombo 0041916966060 colombo@medacta.ch

Locations
France
Clinique du Sport et de Chirurgie Orthopédique Not yet recruiting
Marcq-en-Barœul, France
Contact: Christophe Monnin, Dr. Med         
Principal Investigator: Christophe Monnin, Dr. Med         
Germany
Klinik und Poliklinik für Orthopädie, Physikalische Medizin und Rehabilitation Not yet recruiting
München, Germany
Contact: Peter Müller, Prof Dr. Med         
Principal Investigator: Peter Müller, Prof Dr. Med         
Principal Investigator: Volkmar Jansson, Prof Dr. Med         
Switzerland
Inselspital Recruiting
Bern, Switzerland
Contact: Lilianna Bolliger         
Principal Investigator: Matthias Zumstein, Prof Dr. Med         
Lindenhofspital Recruiting
Bern, Switzerland
Contact: Ralph Hertel, Prof Dr. Med         
Principal Investigator: Ralph Hertel, Prof Dr. Med         
Klinik für Orthopädische Chirurgie und Traumatologie des Bewegungsapparates, Kantonsspital St.Gallen, Recruiting
Saint Gallen, Switzerland
Contact: Bernhard Jost, Prof Dr. Med         
Principal Investigator: Bernhard Jost         
Sponsors and Collaborators
Medacta International SA
Investigators
Principal Investigator: Matthias Zumstein, Prof Dr. Med University Hospital Inselspital, Berne

Responsible Party: Medacta International SA
ClinicalTrials.gov Identifier: NCT03547947     History of Changes
Other Study ID Numbers: P06.001.01
First Posted: June 6, 2018    Key Record Dates
Last Update Posted: June 6, 2018
Last Verified: May 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Chondrocalcinosis
Osteoarthritis
Arthritis, Rheumatoid
Necrosis
Rotator Cuff Injuries
Joint Diseases
Rotator Cuff Tear Arthropathy
Arthritis
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries
Crystal Arthropathies