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Trephination in Arthroscopic Cuff Repair: a Prospective Randomized Controlled

NCT01877772 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2023-03-03

No results posted yet for this study

Summary

This Clinical Trial is being conducted to study an adjunctive treatment for rotator cuff repair; bone trephination."Trephination" is a procedure that involves making small perforations 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. The control group will undergo the standard repair for rotator cuff tears.

It is the investigators' hypothesis that healing rates in patients who undergo bone trephination will be higher compared with surgery without trephination in arthroscopic rotator cuff repair at 24 months post-operatively.

Conditions

  • Rotator Cuff Tear

Interventions

PROCEDURE

Bone Trephination

For the bone trephination, the wire will be advanced into the insertion site through the cortex and into the metaphyseal bone of proximal humerus.

PROCEDURE

Control

The control group will undergo standard rotator cuff repair.

Sponsors & Collaborators

  • Panam Clinic

    collaborator OTHER

  • London Health Sciences Centre

    collaborator OTHER

  • University of Alberta

    collaborator OTHER

  • Ottawa Hospital Research Institute

    lead OTHER

Principal Investigators

  • Peter Lapner, MD · OHRI

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
2013-06-30
Primary Completion
2020-11-30
Completion
2022-01-31

Countries

  • Canada

Study Locations

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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 NCT01877772 on ClinicalTrials.gov