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Completed

NCT Number: NCT02784600

Rotation Medical Bioinductive Implant Database Registry

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.

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Key information

Conditions

Rotator Cuff Tear Rotator Cuff Injuries Rupture Shoulder Injuries Tendon Injuries Wounds and Injuries

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Orthopaedic Specialty Institute, Orange, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

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.

Exclusion criteria

  • Hypersensitive to bovine-derived materials.

Treatment and study plan

Bioinductive implant

Device

Other names: Rotation Medical Rotator Cuff System™

Primary outcomes

  1. Shoulder pain

    Time frame: 1 year

    Change between baseline and post-operative shoulder pain over time using a Visual Analog Scale (VAS).

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

    Time frame: 1 year

    Change between baseline and post-operative ASES shoulder score over time.

  3. Single Assessment Numeric Evaluation (SANE) Score

    Time frame: 1 year

    Change between baseline and post-operative SANE score over time.

  4. Veterans RAND 12 Item Health Survey (VR-12)

    Time frame: 1 year

    Change between baseline and post-operative VR-12 score over time.

  5. Western Ontario Rotator Cuff Index (WORC)

    Time frame: 1 Year

    Change between baseline and post-operative WORC score over time.

Secondary outcomes

  1. Safety assessed by number of Adverse Events and Serious Adverse Events.

    Time frame: 1 Year

    Safety will be evaluated by reporting any Adverse Events that occur over the duration of the study and calculating the overall occurrence rate of Adverse Events and Serious Adverse Events

  2. Recovery by cumulative number of days shoulder is in a sling

    Time frame: 1 Year

  3. Recovery by cumulative time in days between discharge and return to work.

    Time frame: 1 Year

  4. Recovery by cumulative time between discharge and return to driving

    Time frame: 1 Year

  5. Recovery by cumulative time days between discharge and return to overhead-throwing and non-overhead throwing sports

    Time frame: 1 Year

    Overhead-throwing sports overhead-throwing (e.g., baseball, football or exercise where arm extends above head) and non-overhead-throwing (e.g., running, bowling or exercise where arm DOES NOT extend above head) sports.

  6. Recovery by cumulative number physical therapy (PT) visits to rehabilitate the index shoulder.

    Time frame: 1 Year

  7. Recovery by cumulative number of days of narcotic medication use to manage post-operative shoulder pain.

    Time frame: 1 Year

  8. Recovery by cumulative number corticosteroid injections used to manage post-operative shoulder pain.

    Time frame: 1 Year

  9. Revision Surgery

    Time frame: 1 Year

    Number of participants with a revision surgery.

Sponsors and collaborators

Lead sponsor

Smith & Nephew, Inc.

Industry

Registry information

Official study title

Rotation MEdical BioindUctive ImpLant Database (REBUILD) Registry

Acronym: REBUILD

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
May 27, 2016
Registry last updated
Oct 18, 2021

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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