Use of Graft Jacket for Rotator Cuff Repair

Summary

This study is to evaluate the safety and effectiveness of GraftJacket, a human tissue product used in fixing large and massive reparable rotator cuff tears.GraftJacket allograft (Wright Medical Technology, Inc., Arlington, TN) is a biologic tissue that is derived from human dermis. The primary purpose of this study is to determine whether rotator cuff repair augmentation using GraftJacket allograft provides a viable alternative, based on observed clinical outcomes, versus outcomes traditionally achieved with suture and anchor repairs. The study will secondarily investigate the difference in outcomes in patients treated arthroscopically versus open. This study will report patient progress and results at early (6 month) and late (2 year) time points in patients treated for large and massive reparable rotator cuff tears (\>3cm). A reparable tear is defined as a tear of the rotator cuff where it is possible to bring the retracted tendon edge back to the greater tuberosity of the humerus without excessive tension. Restoration of rotator cuff integrity, clinical outcomes and re-tear rate will be included in the study evaluations.

Conditions

• Rotator Cuff Tear

Interventions

DEVICE

Augmentation

Rotator Cuff Repair plus Graft Jacket

PROCEDURE

Rotator Cuff Repair without augmentation

Rotator Cuff Repair without augmentation

Sponsors & Collaborators

• Sports Medicine & Arthroscopic Surgery Bone & Joint Clinic of Houston

  collaborator UNKNOWN

• Southern California Orthopedic Institute Medical Group

  collaborator UNKNOWN

• Kelsey-Seybold Clinic

  collaborator OTHER

• Plano Orthopedic & Sports Medicine Center

  collaborator UNKNOWN

• St Joseph's Hospital Hand & Upper Limb Center

  collaborator UNKNOWN

• Fowler Kennedy Sport Medicine Clinic

  collaborator OTHER

• St. Boniface Hospital

  collaborator OTHER

• Stryker Trauma and Extremities

  lead INDUSTRY

Principal Investigators

• Robert Litchfield, MD, FRCSC · Fowler Kennedy Sport Medicine Clinic

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2007-04-30

Primary Completion

2009-04-30

Completion

2011-03-31

Countries

• United States
• Canada

Study Locations