NCT03021733

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
222

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2012

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 16, 2017

Completed
Last Updated

September 18, 2017

Status Verified

September 1, 2017

Enrollment Period

4.8 years

First QC Date

January 12, 2017

Last Update Submit

September 15, 2017

Conditions

Full Thickness Rotator Cuff Tear

Outcome Measures

Primary Outcomes (7)

  • Veterans Rand VR-12 Quality of Life Score

    baseline

  • Veterans Rand VR-12 Quality of Life Score

    4 weeks

  • Veterans Rand VR-12 Quality of Life Score

    8 weeks

  • Veterans Rand VR-12 Quality of Life Score

    16 weeks

  • Veterans Rand VR-12 Quality of Life Score

    32 weeks

  • Veterans Rand VR-12 Quality of Life Score

    48 weeks

  • Veterans Rand VR-12 Quality of Life Score

    64 weeks

Study Arms (2)

Non-operative

Patients whom elected non-operative treatment

Operative

Patients whom elected operative treatment

Procedure: Operative management

Interventions

Operative managementPROCEDURE

Rotator cuff surgery

Operative

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients presenting to an orthopaedic clinic with full-thickness rotator cuff tears as determined by surgeon opinion and imaging

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 12, 2017

First Posted

January 16, 2017

Study Start

February 1, 2012

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

September 18, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

No individual patient data will be shared