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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03021733
Other study ID # HUM00056320
Secondary ID
Status Completed
Phase N/A
First received January 12, 2017
Last updated September 15, 2017
Start date February 2012
Est. completion date November 2016

Study information

Verified date September 2017
Source University of Michigan
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 222
Est. completion date November 2016
Est. primary completion date November 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 99 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Operative management
Rotator cuff surgery

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Michigan

Outcome

Type Measure Description Time frame Safety issue
Primary Veterans Rand VR-12 Quality of Life Score baseline
Primary Veterans Rand VR-12 Quality of Life Score 4 weeks
Primary Veterans Rand VR-12 Quality of Life Score 8 weeks
Primary Veterans Rand VR-12 Quality of Life Score 16 weeks
Primary Veterans Rand VR-12 Quality of Life Score 32 weeks
Primary Veterans Rand VR-12 Quality of Life Score 48 weeks
Primary Veterans Rand VR-12 Quality of Life Score 64 weeks
See also
  Status Clinical Trial Phase
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Active, not recruiting NCT02484950 - Mesenchymal Stem Cell Augmentation in Patients Undergoing Arthroscopic Rotator Cuff Repair N/A
Completed NCT01557309 - Clinical and Structural Outcome After Early Repair of the Traumatic Rotator Cuff Tear N/A
Completed NCT01819909 - Effectiveness Study of Postoperative Rotator Cuff Repair Rehabilitation N/A
Terminated NCT04115644 - Effectiveness of Corticosteroid vs. Ketorolac Shoulder Injections: A Prospective Double-Blinded Randomized Trial Phase 4
Completed NCT01849458 - BioFiber Scaffold Post-Market Observational Study N/A
Completed NCT02915588 - Early Active Rehabilitation After Arthroscopic Rotator Cuff Repair N/A
Completed NCT01499992 - Rehabilitation of Reconstructed Shoulder Rotator Cuff N/A
Completed NCT01987973 - Allograft Reconstruction of Massive Rotator Cuff Tears vs Partial Repair Alone N/A
Active, not recruiting NCT01481480 - Latissimus Dorsi Tendon Transfer or Partial Arthroscopic Repair of Massive Rotator Cuff Tears N/A
Completed NCT02740946 - Enhanced Function and Quality of Life Following 5 Months of Exercise Therapy for Patients With Rotator Cuff Tears N/A
Completed NCT02750176 - Rehabilitation: Closed-Chain Exercises for Rotator Cuff Tears Early Phase 1