Superior capsular reconstruction of irreparable degenerative rotator cuff tears of the shoulder: a multi-center,comparative, prospective, observational follow-up study

Superior capsular reconstruction of irreparable degenerative rotator cuff tears of the shoulder: a multi-center,comparative, prospective, observational follow-up study - Superior capsular reconstruction of rotator cuff tears

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON48664

Enrollment

Registered

2018-05-22

Start date

2018-02-05

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

degenerative rotator cuff tear wear and tear shoulder tendon

Interventions

Arthroscopic superior capsular reconstruction. Through an arthroscopic surgical procedure, an acellular dermal matrix is sutured to the glenoid and the head of the humerus to overcome the rotator cu

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Age > 40 years; Patiënts with a clinical suspicion of a rotator cuff tear scheduled for arthroscopic superior capsular reconstruction; Patients have signed informed consent.

Exclusion criteria

Exclusion criteria: Patients with rheumatoid arthritis The inability to understand Dutch language Patients with neurologic impairment influencing functioning affected limb

Design outcomes

Primary

Measure	Time frame
The main study parameter is the functional outcome, measured using the Constant-Murley score (including a patient questionnaire and measurements of Range of Motion and muscular strength). This will be measured pre-operatively and at 3, 6, 12 and 24 months post-operatively as well as 5 and 10 years post-operatively.	—

Secondary

Measure	Time frame
Furthermore, pain (NRS-score), function (Disabilities of Arm Shoulder and Hand (DASH) questionnaire) and quality of life (SF12) will be measured and X-rays will be taken to evaluate possible (re)tears. All parameters will be measured pre-operatively and at 3, 6, 12 and 24 months post-operatively, as well as 5 and 10 years post-operatively. Only the radiographs at 3 months will not discarded, since an X-ray is already taken directly post-opeartive, conform standard care.	—

Measure

Time frame

Furthermore, pain (NRS-score), function (Disabilities of Arm Shoulder and Hand (DASH) questionnaire) and quality of life (SF12) will be measured and X-rays will be taken to evaluate possible (re)tears. All parameters will be measured pre-operatively and at 3, 6, 12 and 24 months post-operatively, as well as 5 and 10 years post-operatively. Only the radiographs at 3 months will not discarded, since an X-ray is already taken directly post-opeartive, conform standard care.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)