Rotation Medical Bioinductive Implant Database Registry

Rotator Cuff Tear Clinical Trial

— REBUILD  

Official title:

Rotation MEdical BioindUctive ImpLant Database (REBUILD) Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02784600
• Other study ID #: 3679-01
• Status: Completed
• Start date: April 25, 2016
• Est. completion date: January 16, 2020

Study information

• Verified date: October 2021
• Source: Smith & Nephew, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The purpose of this clinical registry is to prospectively collect and compare preoperative and postoperative patient-reported data using validated shoulder-specific and health-related quality of life (QoL) instruments during real-world use of the Rotation Medical bioinductive implant to treat rotator cuff tears.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 483
• Est. completion date: January 16, 2020
• Est. primary completion date: January 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

1. At least 21 years of age.

2. Able and willing to provide voluntary consent to Registry participation.

3. Able to read, speak, and understand the English language.

Exclusion Criteria:

1. Hypersensitive to bovine-derived materials.

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tear

Intervention

Device:
• Bioinductive implant

Locations

Country	Name	City	State
United States	Central Texas Sports Medicine & Orthopaedics, PA	Bryan	Texas
United States	Lourdes Medical Associates (LMA) Professional	Burlington	New Jersey
United States	Hand and Microsurgery Associates	Columbus	Ohio
United States	Glenwood Orthopaedic Center	Glenwood Springs	Colorado
United States	Andrews Research & Education Foundation	Gulf Breeze	Florida
United States	Andrews Sports Medicine & Orthopaedic Center	Gulf Breeze	Florida
United States	Bone & Joint Clinic of Houston	Houston	Texas
United States	Jacksonville Orthopaedic Institute	Jacksonville	Florida
United States	Norton Orthopaedic & Sports	Louisville	Kentucky
United States	Orthopaedic Surgical Associates	North Chelmsford	Massachusetts
United States	Orthopaedic Specialty Institute	Orange	California
United States	Plano Orthopedic Sports Medicine & Spine Center	Plano	Texas
United States	Atlantic Orthopaedics & Sports Medicine	Portsmouth	New Hampshire
United States	OrthoIllinois, LTD	Rockford	Illinois
United States	Harbin Clinic Orthopaedics & Sports Medicine Rome	Rome	Georgia
United States	Advanced Orthopedics of Detroit, PC	Saint Clair Shores	Michigan
United States	Schofield, Hand, & Bright Orthopaedics	Sarasota	Florida
United States	Stony Brook Orthopaedics	Setauket	New York
United States	Westchester Medical Pavilion	White Plains	New York

Sponsors (1)

Lead Sponsor	Collaborator
Smith & Nephew, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shoulder pain	Change between baseline and post-operative shoulder pain over time using a Visual Analog Scale (VAS).	1 year
Primary	American Shoulder and Elbow Surgeons Standardized Form for the Assessment of the Shoulder (ASES)	Change between baseline and post-operative ASES shoulder score over time.	1 year
Primary	Single Assessment Numeric Evaluation (SANE) Score	Change between baseline and post-operative SANE score over time.	1 year
Primary	Veterans RAND 12 Item Health Survey (VR-12)	Change between baseline and post-operative VR-12 score over time.	1 year
Primary	Western Ontario Rotator Cuff Index (WORC)	Change between baseline and post-operative WORC score over time.	1 Year
Secondary	Safety assessed by number of Adverse Events and Serious Adverse Events.	Safety will be evaluated by reporting any Adverse Events that occur over the duration of the study and calculating the overall occurrence rate of Adverse Events and Serious Adverse Events	1 Year
Secondary	Recovery by cumulative number of days shoulder is in a sling		1 Year
Secondary	Recovery by cumulative time in days between discharge and return to work.		1 Year
Secondary	Recovery by cumulative time between discharge and return to driving		1 Year
Secondary	Recovery by cumulative time days between discharge and return to overhead-throwing and non-overhead throwing sports	Overhead-throwing sports overhead-throwing (e.g., baseball, football or exercise where arm extends above head) and non-overhead-throwing (e.g., running, bowling or exercise where arm DOES NOT extend above head) sports.	1 Year
Secondary	Recovery by cumulative number physical therapy (PT) visits to rehabilitate the index shoulder.		1 Year
Secondary	Recovery by cumulative number of days of narcotic medication use to manage post-operative shoulder pain.		1 Year
Secondary	Recovery by cumulative number corticosteroid injections used to manage post-operative shoulder pain.		1 Year
Secondary	Revision Surgery	Number of participants with a revision surgery.	1 Year