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NCT Number: NCT05926622

Clinical and Radiological Outcomes of Medacta Shoulder System FR

This is a post-marketing surveillance on Medacta Shoulder System

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Key information

Conditions

Primary Osteoarthritis Arthritis Avascular Necrosis Bone Diseases Chondrocalcinosis Crystal Arthropathies Fracture Fractures, Bone Joint Diseases Musculoskeletal Diseases Necrosis Osteonecrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Revision of Shoulder Arthroplasty Rheumatoid Arthritis Shoulder Rotator Cuff Tear Arthropathy Secondary Osteoarthritis Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Survival Rate

    Time frame: 10 years

    Kaplan Meier method

Secondary outcomes

  1. Clinical outcome evaluating Constant & Murley Score

    Time frame: 1, 2, 5 and 10 years

    Constant & Murley Score (CMS): The CMS is a multi-item functional scale assessing pain, ADL, ROM and strength of the affected shoulder. Its score ranges from 0 to 100 points, representing worst and best shoulder function, respectively

  2. Functional outcome evaluating Oxford Shoulder Score

    Time frame: 1, 2, 5 and 10 years

    Oxford Shoulder Score (OSS): The Oxford Shoulder Score is a unidimensional score comprising 12 questions. Starting with 1 (best/fewest symptoms) to 5 (worst/most severe) which is awarded to correspond to the patient's symptoms. The total gives a minimum score of 12 and a maximum of 60. A higher score implies a greater degree of disability.

  3. Radiographic performance of the implants evaluating presence of radiolucencies

    Time frame: 3 months, 1, 2, 5 and 10 years

    presence of radiolucencies

  4. Patient evaluation quality of life

    Time frame: 1, 2, 5 and 10 years

    EQ-5D-5L: The EQ-5D-5L is a self-assessed, health related, quality of life questionnaire. The scale measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. Typically it is calculated by assigning a numerical value to each response level (i.e., 1 for "no problems", 5 for "extreme problems"/"unable to") and summing these values across the five items, resulting in a score from 5 (no problems on any dimension) to 25 (extreme problems on all dimensions)

  5. Adverse events

    Time frame: up to 10 years

    record of adverse event

Study contacts

Contact information is provided by the study sponsor or research team.

Arianna Girardi

CONTACT

[email protected]

+41 91 696 60 60

Sponsors and collaborators

Lead sponsor

Medacta International SA

Industry

Registry information

Official study title

Clinical and Radiological Outcomes of Medacta Shoulder System

Important dates

Study start
2022
Primary completion
2032
Study completion
2037
First posted
Jul 3, 2023
Registry last updated
Sep 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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