A Comparison of Two Adjunctive Treatments in Arthroscopic Cuff Repair

NCT01706978 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 176

Last updated 2020-09-18

Study results available
· View outcomes & findings →

Summary

This Clinical Trial is being conducted to study two adjunctive treatments for rotator cuff repair; soft tissue and bone trephination. "Trephination" is a procedure that involves making small perforations either in the torn tendon near its edge, or in the bone that the tendon is repaired to. The rotator cuff is repaired by sewing the tendon down to the bone in the shoulder. Trephination is a new technique that is used in addition to the standard method of repairing the rotator cuff tendon.

This study will help to determine whether this technique improves the speed of healing, the strength and the re-tear rate of the repair. You are being asked to take part in this study because you have a tear of the rotator cuff that requires surgical treatment. A total of 90 participants will participate in this study.

Conditions

  • Rotator Cuff Tear

Interventions

PROCEDURE

Bone Trephination

PROCEDURE

Soft Tissue Trephination

Sponsors & Collaborators

  • University of Ottawa

    collaborator OTHER
  • Ottawa Hospital Research Institute

    lead OTHER

Principal Investigators

  • Peter Lapner, MD · The Ottawa Hospital

  • Guy Trudel, MD · University of Ottawa

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2018-09-30
Completion
2018-09-30

Countries

  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01706978 on ClinicalTrials.gov