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NCT Number: NCT05002335

Clinical and Radiological Outcomes of Medacta Shoulder System (BE)

This is a post-market surveillance study on Medacta Shoulder System

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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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

AZ Sint-Jan, Bruges, Belgium

Loading trial locations.

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

Medacta Shoulder System

Device

Performance of Total Shoulder Arthroplasty (anatomic/reverse) with Medacta Shoulder System

Primary outcomes

  1. Survival rate

    Time frame: 5 years

    Kaplan Meier method

Secondary outcomes

  1. Clinical outcome; Constant and Murley score

    Time frame: 1, 2, and 5 years

    Constant & Murley Score: Its score ranges from 0 to 100 points, representing worst and best shoulder function, respectively. The pain experienced during normal activities of daily living was scored as: no pain = 15 points, mild = 10, moderate = 5 and severe = 0 points.

  2. Functional outcome: Oxford Shoulder Score

    Time frame: 1, 2, and 5 years

    Oxford Shoulder Score: It contains 12 items, each with 5 potential answers. A mark between 1 (best/fewest symptoms) and 5 (worst/most severe) is awarded to correspond to the patient's symptoms. The combined 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: Presence of radiolucencies

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

    Presence of radiolucencies

  4. Quality of life assesed by EQ-5D-5L score

    Time frame: 1, 2, and 5 years

    EQ-5D-5L score: 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. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.

    The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.

  5. Number of Intraoperative and postoperative Adverse events

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

    Intraoperative and postoperative adverse events

Sponsors and collaborators

Lead sponsor

Medacta International SA

Industry

Registry information

Important dates

Study start
2020
Primary completion
2026
Study completion
2027
First posted
Aug 12, 2021
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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