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Evaluation of JuggerKnot Soft Anchor Behaviour and Bone Remodelling in Rotator Cuff Repair Surgery

Evaluation of JuggerKnot Soft Anchor Behaviour and Bone Remodelling in Rotator Cuff Repair Surgery - JARS

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON44868
Enrollment
50
Registered
2014-03-03
Start date
2014-07-03
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

rotatorcuff tear shoulder complaints

Interventions

None listed

Sponsors

Haaglanden Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - On MRA or CTA proven symptomatic full-thickness rotator cuff tear of the supraspinatus and/or infraspinatus tendon. - Age between 18 and 70 years - Oral and written informed consent

Exclusion criteria

Exclusion criteria: - Glenohumeral instability - Frozen shoulder - Rheumatoid arthritis - Previous shoulder infection - Previous cuff repair on the same shoulder - Cuff arthropathy - High risk of non compliance, e.g. patients without a permanent home or substance abuse - No Dutch language mastered

Design outcomes

Primary

MeasureTime frame
Measurement of bone tunnel dimensions and orientation in humeral head after anchor placement on CT scan (direct postoperative and at 1 year)

Secondary

MeasureTime frame
Integrity of the rotator cuff repair on CT-arthrography (1 year postoperative), patient subjective outcome measures: CS, WORC, SST, DASH (preoperative, 6 weeks, 3 months, 6 months, 1 year and 2 years postoperative. Correlations between outcome and integrity.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)