Use of Graft Jacket for Rotator Cuff Repair

NCT00456781 | Completed

• 1 other identifier: Wright1
• Study Type: interventional
• Target: 79
• Locations: 2 countries
• Sites: 7

Brief 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

Keywords

rotator cuff; randomized clinical trial

Outcome Measures

Primary Outcomes (1)

• less or no recurrence of shoulder rotator cuff tear with the use of the tissue scaffold than with the standard use of surgical anchors and screws as measured by MRI results

  each subject will be eligible for the study based on the Pre-operative results of the MRI as it relates to the size of the tissue tear. The subjects will be assigned to either the tissue scaffold material or the standard surgical suture or anchors. Then, the procedure to repair is determined by the investigator as an arthoscopic or open procedure. Pos-operative evalutions via MRI will be obtained throughout the study to evaluate the effectiveness of the surgical procedure and for the measurement of retear or not.

  2 years

Secondary Outcomes (4)

• Scale (pain, ADL, Shoulder stability)

  2 years

• UCLA Shoulder Score (pain, function, manual muscle testing)

  2 years

• Constant-Murley Shoulder Score (pain, function, ROM, Strength)

  2 years

• Surgeon Reported Satisfaction

  2 years

Study Arms (2)

Augmentation

EXPERIMENTAL

Rotator Cuff Repair augmented with the Graft Jacket Device

Device: Augmentation

No Augmentation

ACTIVE COMPARATOR

Rotator Cuff RFepair

Device: Augmentation; Procedure: Rotator Cuff Repair without augmentation

Interventions

Augmentation DEVICE

Rotator Cuff Repair plus Graft Jacket

Also known as: Wright Medical Technology Graft Jacket

Augmentation; No Augmentation

Rotator Cuff Repair without augmentation PROCEDURE

Rotator Cuff Repair without augmentation

No Augmentation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients between the ages of 18 - 75 years inclusive,
• Reads, understand and able to complete the patient reported outcomes in English,
• Patients with large and massive rotator cuff tears of more than 3cm, which can be repaired either arthroscopically or by open surgery.,
• Patients with either primary or revision rotator cuff tears measuring \< 5cm with at least 2 tendon involvement as indicated by MRI,
• Patients who have a reasonable movement of the non-operative arm, defined as a shoulder elevation of equal or more than 90°, and are able to perform (postoperative) exercises,
• Patients for whom there is a reasonable expectation that he or she will be available for each protocol required post-operative follow-up examination,
• Patients must complete the informed consent process (including any regulatory requirements such as HIPAA authorization) agreeing to participate and signing the informed consent form prior to the site conducting any study related procedures.

You may not qualify if:

• Patients with irreparable large or massive rotator cuff tears \<3cm will be excluded if found intra-operatively
• Patients with rotator cuff tears where the subscapularis tendon is disrupted,
• Patients with inflammatory or auto-immune based joint diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus),
• Patients with evidence of active infection, cancer, or highly communicable diseases that would preclude the patient from completing required patient assessments and clinic visits as described in the protocol,
• Patients who smoke,
• Patients with a documented history of drug abuse within six months of treatment,
• Any other condition, that in the opinion of the investigator, that would preclude the patient from enrollment.
• Females of child-bearing potential who are pregnant or breastfeeding, or plan to become pregnant during the course of the study

Sponsors & Collaborators

• Stryker Trauma and Extremities: lead
• Sports Medicine & Arthroscopic Surgery Bone & Joint Clinic of Houston: collaborator
• Southern California Orthopedic Institute Medical Group: collaborator
• Kelsey-Seybold Clinic: collaborator
• Plano Orthopedic & Sports Medicine Center: collaborator
• St Joseph's Hospital Hand & Upper Limb Center: collaborator
• Fowler Kennedy Sport Medicine Clinic: collaborator
• St. Boniface Hospital: collaborator

Study Sites (7)

Southern California Orthopedic Institute

Simi Valley, California, 93063, United States

Location

Bone and Joint Clinic of Houston

Houston, Texas, 77005, United States

Location

Kelsey-Seybold Orthopedic

Houston, Texas, 77025, United States

Location

Plano Orthopedic & Sports Medicine

Plano, Texas, 75093, United States

Location

Pan Am Clinic

Winnipeg, Manitoba, RM3-3E4, Canada

Location

Fowler Kennedy Sport Medicine Clinic

London, Ontario, N6A 3K7, Canada

Location

The Hand and Upper Limb Centre

London, Ontario, NSA-4L6, Canada

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• Robert Litchfield, MD, FRCSC

  Fowler Kennedy Sport Medicine Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Principal Investigator

Study Record Dates

• First Submitted: February 21, 2007
• First Posted: April 5, 2007
• Study Start: April 1, 2007
• Primary Completion: April 1, 2009
• Study Completion: March 1, 2011
• Last Updated: July 3, 2014

Record last verified: 2014-07

Locations

US (4); CA (3)