Rotation Medical Bioinductive Implant Database Registry (REBUILD)

Rotation MEdical BioindUctive ImpLant Database (REBUILD) Registry

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.

Study Overview

• Status: Completed
• Conditions: Rotator Cuff Tear
• Intervention / Treatment: Device: Bioinductive implant

• Study Type: Observational
• Enrollment (Actual): 483

Contacts and Locations

Study Locations

• United States
  • California
    • Orange, California, United States, 92868
      • Orthopaedic Specialty Institute
  • Colorado
    • Glenwood Springs, Colorado, United States, 81601
      • Glenwood Orthopaedic Center
  • Florida
    • Gulf Breeze, Florida, United States, 32561
      • Andrews Research & Education Foundation
    • Gulf Breeze, Florida, United States, 32561
      • Andrews Sports Medicine & Orthopaedic Center
    • Jacksonville, Florida, United States, 32204
      • Jacksonville Orthopaedic Institute
    • Sarasota, Florida, United States, 34239
      • Schofield, Hand, & Bright Orthopaedics
  • Georgia
    • Rome, Georgia, United States, 30165
      • Harbin Clinic Orthopaedics & Sports Medicine Rome
  • Illinois
    • Rockford, Illinois, United States, 61107
      • OrthoIllinois, LTD
  • Kentucky
    • Louisville, Kentucky, United States, 40241
      • Norton Orthopaedic & Sports
  • Massachusetts
    • North Chelmsford, Massachusetts, United States, 01863
      • Orthopaedic Surgical Associates
  • Michigan
    • Saint Clair Shores, Michigan, United States, 48080
      • Advanced Orthopedics of Detroit, PC
  • New Hampshire
    • Portsmouth, New Hampshire, United States, 03801
      • Atlantic Orthopaedics & Sports Medicine
  • New Jersey
    • Burlington, New Jersey, United States, 08016
      • Lourdes Medical Associates (LMA) Professional
  • New York
    • Setauket, New York, United States, 11733
      • Stony Brook Orthopaedics
    • White Plains, New York, United States, 10606
      • Westchester Medical Pavilion
  • Ohio
    • Columbus, Ohio, United States, 43240
      • Hand and Microsurgery Associates
  • Texas
    • Bryan, Texas, United States, 77802
      • Central Texas Sports Medicine & Orthopaedics, PA
    • Houston, Texas, United States, 77030
      • Bone & Joint Clinic Of Houston
    • Plano, Texas, United States, 75093
      • Plano Orthopedic Sports Medicine & Spine Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Partial or full-thickness rotator cuff tear; Rotation Medical bioinductive implant	Device: Bioinductive implant; Other Names: Rotation Medical Rotator Cuff System™

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shoulder pain	Change between baseline and post-operative shoulder pain over time using a Visual Analog Scale (VAS).	1 year
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
Single Assessment Numeric Evaluation (SANE) Score	Change between baseline and post-operative SANE score over time.	1 year
Veterans RAND 12 Item Health Survey (VR-12)	Change between baseline and post-operative VR-12 score over time.	1 year
Western Ontario Rotator Cuff Index (WORC)	Change between baseline and post-operative WORC score over time.	1 Year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Recovery by cumulative number of days shoulder is in a sling		1 Year
Recovery by cumulative time in days between discharge and return to work.		1 Year
Recovery by cumulative time between discharge and return to driving		1 Year
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
Recovery by cumulative number physical therapy (PT) visits to rehabilitate the index shoulder.		1 Year
Recovery by cumulative number of days of narcotic medication use to manage post-operative shoulder pain.		1 Year
Recovery by cumulative number corticosteroid injections used to manage post-operative shoulder pain.		1 Year
Revision Surgery	Number of participants with a revision surgery.	1 Year

Collaborators and Investigators

• Sponsor: Smith & Nephew, Inc.
• Investigators: Principal Investigator: Louis McIntyre, MD, Phelps Medical Associates

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 25, 2016
• Primary Completion (ACTUAL): January 16, 2020
• Study Completion (ACTUAL): January 16, 2020

Study Registration Dates

• First Submitted: May 18, 2016
• First Submitted That Met QC Criteria: May 24, 2016
• First Posted (ESTIMATE): May 27, 2016

Study Record Updates

• Last Update Posted (ACTUAL): October 18, 2021
• Last Update Submitted That Met QC Criteria: October 15, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Partial-thickness; Full-thickness
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: 3679-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes