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Completed

NCT Number: NCT03021733

A Pilot Cohort Study of Surgical and Non-surgical Management of Rotator Cuff Tears

This project will involve planning and implementing a two-arm prospective pragmatic cohort clinical trial in patients with known rotator cuff tears.

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Key information

Conditions

Full Thickness Rotator Cuff Tear

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

About this study

This project will involve planning and implementing a two-arm prospective pragmatic cohort clinical trial in patients with known rotator cuff tears. Pragmatic or effectiveness clinical trials reflect real world settings and thus have greater external generalizability than efficacy trials. The evaluation component in this trial will be three-fold: first, the study team will compare the success of patients undergoing operative versus non-operative management and identify which variables predict success in each group; second, investigators will attempt to predict which patients end up choosing, along with their care giver(s), operative versus non-operative management by examining the predictive capability of a selection of variables; third, investigators will evaluate the clinical research site(s), personnel, and implementation processes for their capability to implement clinical trials with the intent of planning for a future large multi-site clinical trial building on the results of the present study.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients over 18 years of age with full-thickness rotator cuff tears eligible for operative repair

Exclusion criteria

  • less than 18 years old,
  • non-operative rotator cuff tears,
  • calcific tendonitis, fracture, adhesive capsulitis,
  • severe osteoarthritis of the shoulder,
  • no prior shoulder surgery

Treatment and study plan

Operative management

Procedure

Rotator cuff surgery

Primary outcomes

  1. Veterans Rand VR-12 Quality of Life Score

    Time frame: baseline

  2. Veterans Rand VR-12 Quality of Life Score

    Time frame: 4 weeks

  3. Veterans Rand VR-12 Quality of Life Score

    Time frame: 8 weeks

  4. Veterans Rand VR-12 Quality of Life Score

    Time frame: 16 weeks

  5. Veterans Rand VR-12 Quality of Life Score

    Time frame: 32 weeks

  6. Veterans Rand VR-12 Quality of Life Score

    Time frame: 48 weeks

  7. Veterans Rand VR-12 Quality of Life Score

    Time frame: 64 weeks

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Jan 16, 2017
Registry last updated
Sep 18, 2017

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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