NCT02784600

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
483

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2016

Typical duration for all trials

Geographic Reach
1 country

19 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 25, 2016

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

May 18, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 27, 2016

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 16, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 16, 2020

Completed
Last Updated

October 18, 2021

Status Verified

October 1, 2021

Enrollment Period

3.7 years

First QC Date

May 18, 2016

Last Update Submit

October 15, 2021

Conditions

Rotator Cuff Tear

Keywords

Partial-thicknessFull-thickness

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (9)

  • Safety assessed by number 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

    1 Year

  • +4 more secondary outcomes

Study Arms (1)

Partial or full-thickness rotator cuff tear

Rotation Medical bioinductive implant

Device: Bioinductive implant

Interventions

Bioinductive implantDEVICE
Also known as: Rotation Medical Rotator Cuff Systemâ„¢
Partial or full-thickness rotator cuff tear

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • At least 21 years of age.
  • Able and willing to provide voluntary consent to Registry participation.
  • Able to read, speak, and understand the English language.

You may not qualify if:

  • \. Hypersensitive to bovine-derived materials.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Orthopaedic Specialty Institute

Orange, California, 92868, United States

Location

Glenwood Orthopaedic Center

Glenwood Springs, Colorado, 81601, United States

Location

Andrews Research & Education Foundation

Gulf Breeze, Florida, 32561, United States

Location

Andrews Sports Medicine & Orthopaedic Center

Gulf Breeze, Florida, 32561, United States

Location

Jacksonville Orthopaedic Institute

Jacksonville, Florida, 32204, United States

Location

Schofield, Hand, & Bright Orthopaedics

Sarasota, Florida, 34239, United States

Location

Harbin Clinic Orthopaedics & Sports Medicine Rome

Rome, Georgia, 30165, United States

Location

OrthoIllinois, LTD

Rockford, Illinois, 61107, United States

Location

Norton Orthopaedic & Sports

Louisville, Kentucky, 40241, United States

Location

Orthopaedic Surgical Associates

North Chelmsford, Massachusetts, 01863, United States

Location

Advanced Orthopedics of Detroit, PC

Saint Clair Shores, Michigan, 48080, United States

Location

Atlantic Orthopaedics & Sports Medicine

Portsmouth, New Hampshire, 03801, United States

Location

Lourdes Medical Associates (LMA) Professional

Burlington, New Jersey, 08016, United States

Location

Stony Brook Orthopaedics

Setauket, New York, 11733, United States

Location

Westchester Medical Pavilion

White Plains, New York, 10606, United States

Location

Hand and Microsurgery Associates

Columbus, Ohio, 43240, United States

Location

Central Texas Sports Medicine & Orthopaedics, PA

Bryan, Texas, 77802, United States

Location

Bone & Joint Clinic of Houston

Houston, Texas, 77030, United States

Location

Plano Orthopedic Sports Medicine & Spine Center

Plano, Texas, 75093, United States

Location

Related Publications (1)

  • 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.

    PMID: 31350082DERIVED

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon Injuries

Study Officials

  • Louis McIntyre, MD

    Phelps Medical Associates

    PRINCIPAL INVESTIGATOR

  • Rachael Winter

    Smith & Nephew, Inc.

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2016

First Posted

May 27, 2016

Study Start

April 25, 2016

Primary Completion

January 16, 2020

Study Completion

January 16, 2020

Last Updated

October 18, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

US(19)