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

Full Thickness Rotator Cuff Tear Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03021733
• Other study ID #: HUM00056320
• 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
• 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

Related Conditions & MeSH terms

• Full Thickness Rotator Cuff Tear

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