Clinical trial NCT01256242: Pilot Study of Augment Rotator Cuff for Surgical Treatment of Full Thickness Rotator Cuff Tears
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Full Thickness Rotator Cuff Tear
Keywords: tendon
shoulder
rotator cuff
Glenohumeral
Lead sponsor: BioMimetic Therapeutics
Sponsor class: INDUSTRY
First posted: 2010-12-08
Enrollment: 31
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Magnetic Resonance Imaging (MRI)
timeFrame: 24 weeks
measure: Disabilities of the Arm, Shoulder and Hand (DASH)
timeFrame: 24 weeks
measure: Western Ontario Rotator Cuff Index (WORC)
timeFrame: 24 weeks
measure: Constant-Murley Shoulder Outcome Score (CSS)
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: Canada
facility: Fowler Kennedy Sports Medicine Clinic
state: Ontario
city: London
country: Canada
facility: Hand and Upper Limb Clinic - St. Joseph's Health Care London
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital
state: Ontario
city: Toronto
country: Canada
facility: St. Michaels Hospital
state: Ontario
Study officials:
affiliation: Fowler Kennedy Sport Medicine Clinic
name: Robert Litchfield, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
References: