CompletedNot Applicable

Rotation Medical Bioinductive Implant Database Registry

United States483 participantsStarted 2016-04-25

Plain-language summary

The purpose of this clinical registry is to prospectively collect and compare preoperative and postoperative patient-reported data using validated shoulder-specific and health-related quality of life (QoL) instruments during real-world use of the Rotation Medical bioinductive implant to treat rotator cuff tears.

Who can participate

Age range21 Years

SexALL

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Inclusion criteria

✓. At least 21 years of age.
✓. Able and willing to provide voluntary consent to Registry participation.
✓. Able to read, speak, and understand the English language.

What they're measuring

Shoulder pain

Timeframe: 1 year

American Shoulder and Elbow Surgeons Standardized Form for the Assessment of the Shoulder (ASES)

Timeframe: 1 year

Single Assessment Numeric Evaluation (SANE) Score

Timeframe: 1 year

Veterans RAND 12 Item Health Survey (VR-12)

Timeframe: 1 year

Western Ontario Rotator Cuff Index (WORC)

Timeframe: 1 Year

Trial details

NCT IDNCT02784600

SponsorSmith & Nephew, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2020-01-16

View on ClinicalTrials.gov More Rotator Cuff Tear trials