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Arthroscopic Transosseous vs. Anchored Rotator Cuff Repair

NCT03797287 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2019-05-30

No results posted yet for this study

Summary

This study will compare arthroscopic transosseous versus anchored rotator cuff repairs in terms of clinical outcomes, rotator cuff integrity, and cost-effectiveness. With the collection of patient-reported outcomes the health of patients undergoing each rotator cuff repair technique will be assessed. The aims of this study will be achieved through a clinical randomized controlled trial and a cost-effectiveness analysis.

Conditions

  • Shoulder Pain Chronic
  • Shoulder Pain
  • Rotator Cuff Tear
  • Rotator Cuff Injury

Interventions

DEVICE

Tensor Tunnler

Create the bone tunnels during the arthroscopic rotator cuff repair procedure

PROCEDURE

Anchor Rotator Cuff Repair

The suture anchors (Smith and Nephew PEEK Helicoil Anchor) are inserted in bone and the sutures are then used to sew the tendons to bone arthroscopically.

Sponsors & Collaborators

Principal Investigators

  • Uma Srikumaran, MD, MBA · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-02-01
Primary Completion
2025-12-31
Completion
2025-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT03797287 on ClinicalTrials.gov