Pilot Study of Augment Rotator Cuff for Surgical Treatment of Full Thickness Rotator Cuff Tears

Full Thickness Rotator Cuff Tear Clinical Trial

Official title:

A Single Blinded, Multi-center, Randomized, Controlled, Pilot Study to Evaluate the Safety and Performance of Augment™ Rotator Cuff for Primary Surgical Treatment of Full Thickness Rotator Cuff Tears

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01256242
• Other study ID #: BMTI-2010-03
• Status: Completed
• Phase: N/A
• Start date: November 24, 2010
• Est. completion date: November 16, 2012

Study information

• Verified date: February 2019
• Source: BioMimetic Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Study Purpose: To evaluate the safety and performance of Augment Rotator Cuff as a primary surgical treatment for full thickness rotator cuff tears. The hypothesis is that Augment Rotator Cuff will be easy to deliver as an inter-positional graft placed between the rotator cuff tendon and the humeral head providing further enhanced tendon to bone healing without adding any additional safety risk to the patient.

Study Rationale: To evaluate the safety and performance Augment™ Rotator Cuff in surgical intervention of a torn rotator cuff and to obtain preliminary data to support the rationale for a subsequent pivotal clinical trial.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: November 16, 2012
• Est. primary completion date: November 16, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• The subject has a repairable rotator cuff tear with an estimated full thickness size of = 2 cm to < 5 cm confirmed with diagnostic MRI in AP or ML dimension

• The subject is independent, ambulatory, and can comply with all post-operative evaluations and visits

• The subject is at least twenty one (21) years of age and considered to be skeletally mature.

Exclusion Criteria:

• The subject has undergone previous rotator cuff repair surgery to the affected shoulder

• The subject has a partial thickness rotator cuff tear

• The subject requires a concomitant subscapularis repair

• The subject requires a concomitant labral repair

• The subject has an irreparable rotator cuff tear

• The subject has an allergy to yeast-derived products or a known bovine collagen allergy

• The subject has implanted metallic devices (cardiac pacemakers, insulin pumps, and nerve stimulators), medically implanted clips or other electronically, magnetically or mechanically activated implants that would contraindicate undergoing an MRI scan of the shoulder

• The subject has tested positive or has been treated for a malignancy in the past or is suspected of having a malignancy or is currently undergoing radiation or chemotherapy treatment for a malignancy anywhere in the body, whether adjacent to or distant from the proposed Augment Rotator Cuff implantation site

• The subject's condition represents a worker's compensation case

• The subject is currently involved in a health-related litigation procedure

• The subject is pregnant or able to become pregnant but not practicing a medically-accepted form of birth control, and/or intending to become pregnant during this study period

Related Conditions & MeSH terms

• Full Thickness Rotator Cuff Tear
• Rotator Cuff Injuries

Intervention

Device:
• Augment Rotator Cuff
rhPDGF-BB and bovine collagen matrix

Procedure:
• Standard Suture Repair
standard suture repair

Locations

Country	Name	City	State
Canada	Fowler Kennedy Sports Medicine Clinic	London	Ontario
Canada	Hand and Upper Limb Clinic - St. Joseph's Health Care London	London	Ontario
Canada	Ottawa Hospital	Ottawa	Ontario
Canada	St. Michaels Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
BioMimetic Therapeutics

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Magnetic Resonance Imaging (MRI)	The scans were evaluated for degree of re-tears (no re-tears, partial or complete re-tear) by an independent radiologist to assess device integrity and surgical treatment of the rotator cuff tear.	24 weeks
Primary	Disabilities of the Arm, Shoulder and Hand (DASH)	a self-report questionnaire evaluates the subjects' symptoms and ability to perform activities of daily living, athletic activities and homemaking/work activities. The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100	24 weeks
Primary	Western Ontario Rotator Cuff Index (WORC)	a self-report questionnaire specifically designed to evaluate disability in persons with pathology of the rotator cuff. Each question uses a visual analogue scale (VAS) - which is a straight line, representing a 100-point scale, ranging from 0-100, with a higher score representing lower quality of life.	24 weeks
Primary	Constant-Murley Shoulder Outcome Score (CSS)	to assess the shoulder and determine at minimum the range of motion (ROM), external rotation and internal rotation, and power score. The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient. The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points). The higher the score, the higher the quality of the function.	24 weeks

External Links

•   American Academy of Orthopaedic Surgeons