Clinical trial NCT02784600: Rotation Medical Bioinductive Implant Database Registry
Official title: Rotation MEdical BioindUctive ImpLant Database (REBUILD) Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rotator Cuff Tear
Keywords: Partial-thickness
Full-thickness
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2016-05-27
Enrollment: 483
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This clinical registry will be a prospective, multi-center registry conducted under a common protocol where all subjects will undergo treatment with the Rotation Medical bioinductive implant.

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Shoulder pain
timeFrame: 1 year
measure: American Shoulder and Elbow Surgeons Standardized Form for the Assessment of the Shoulder (ASES)
timeFrame: 1 year
measure: Single Assessment Numeric Evaluation (SANE) Score
timeFrame: 1 year
measure: Veterans RAND 12 Item Health Survey (VR-12)
timeFrame: 1 year
measure: Western Ontario Rotator Cuff Index (WORC)
timeFrame: 1 Year
Secondary outcomes:
measure: Safety assessed by number of Adverse Events and Serious Adverse Events.
timeFrame: 1 Year
measure: Recovery by cumulative number of days shoulder is in a sling
timeFrame: 1 Year
measure: Recovery by cumulative time in days between discharge and return to work.
timeFrame: 1 Year
measure: Recovery by cumulative time between discharge and return to driving
timeFrame: 1 Year
measure: Recovery by cumulative time days between discharge and return to overhead-throwing and non-overhead throwing sports
timeFrame: 1 Year
measure: Recovery by cumulative number physical therapy (PT) visits to rehabilitate the index shoulder.
timeFrame: 1 Year
measure: Recovery by cumulative number of days of narcotic medication use to manage post-operative shoulder pain.
timeFrame: 1 Year
measure: Recovery by cumulative number corticosteroid injections used to manage post-operative shoulder pain.
timeFrame: 1 Year
measure: Revision Surgery
timeFrame: 1 Year
Other outcomes:
Locations:
city: Orange
country: United States
facility: Orthopaedic Specialty Institute
state: California
city: Glenwood Springs
country: United States
facility: Glenwood Orthopaedic Center
state: Colorado
city: Gulf Breeze
country: United States
facility: Andrews Research & Education Foundation
state: Florida
city: Gulf Breeze
country: United States
facility: Andrews Sports Medicine & Orthopaedic Center
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Orthopaedic Institute
state: Florida
city: Sarasota
country: United States
facility: Schofield, Hand, & Bright Orthopaedics
state: Florida
city: Rome
country: United States
facility: Harbin Clinic Orthopaedics & Sports Medicine Rome
state: Georgia
city: Rockford
country: United States
facility: OrthoIllinois, LTD
state: Illinois
city: Louisville
country: United States
facility: Norton Orthopaedic & Sports
state: Kentucky
city: North Chelmsford
country: United States
facility: Orthopaedic Surgical Associates
state: Massachusetts
city: Saint Clair Shores
country: United States
facility: Advanced Orthopedics of Detroit, PC
state: Michigan
city: Portsmouth
country: United States
facility: Atlantic Orthopaedics & Sports Medicine
state: New Hampshire
city: Burlington
country: United States
facility: Lourdes Medical Associates (LMA) Professional
state: New Jersey
city: Setauket
country: United States
facility: Stony Brook Orthopaedics
state: New York
city: White Plains
country: United States
facility: Westchester Medical Pavilion
state: New York
city: Columbus
country: United States
facility: Hand and Microsurgery Associates
state: Ohio
city: Bryan
country: United States
facility: Central Texas Sports Medicine & Orthopaedics, PA
state: Texas
city: Houston
country: United States
facility: Bone & Joint Clinic of Houston
state: Texas
city: Plano
country: United States
facility: Plano Orthopedic Sports Medicine & Spine Center
state: Texas
Study officials:
affiliation: Phelps Medical Associates
name: Louis McIntyre, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Smith & Nephew, Inc.
name: Rachael Winter
role: STUDY_CHAIR
References:
citation: McIntyre LF, Bishai SK, Brown PB 3rd, Bushnell BD, Trenhaile SW. Patient-Reported Outcomes After Use of a Bioabsorbable Collagen Implant to Treat Partial and Full-Thickness Rotator Cuff Tears. Arthroscopy. 2019 Aug;35(8):2262-2271. doi: 10.1016/j.arthro.2019.02.019. Epub 2019 Jul 23.