RECRUITING

Use of the REGENETEN™ Bioinductive Implant System in High Grade Partial-thickness Tears

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Conditions

Rotator Cuff InjuriesRotator cuff tearHigh grade partial thickness tearsREGENETEN Bioinductive Implant System

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of the study is to assess whether the REGENETEN™ Bioinductive Implant allows patients to get back to their everyday activities quicker than if the tendon is repaired by the standard repair technique 'Completion and Repair' for surgically treating partial-thickness rotator cuff tears.

Official Title

Evaluation of Safety and Efficacy of a Resorbable Collagen Implant in Treatment of High Grade PArtial ThiCkness Tears; A Prospective, Multicenter, Randomized, Control Trial (IMPACT Study)

Quick Facts

Study Start:2022-08-30
Study Completion:2027-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05444465

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * The subject must provide written informed consent.
  2. * Subject is \> eighteen (18) years of age (no upper limit).
  3. * Subject has an isolated high-grade (\>50% or \>6mm) (Ellman grade III) partial thickness tear of supraspinatus or supraspinatus with infraspinatus.
  4. * Subject has failed a minimum of 3 months of conservative management for treatment of partial thickness rotator cuff tear.
  5. * Subject willing and able to make all required study visits.
  6. * Subject able to follow instructions and deemed capable of completing all study questionnaires.
  1. * Subjects with insufficient tendon tissue quality for management and protection of the tendon injury using the isolated REGENETEN Bioinductive Implant system.
  2. * Subjects where the prescribed Physical Therapy guidelines stated in the protocol are not suitable for their rehabilitation.
  3. * Subjects with Samilson-Prieto osteoarthritis grade 2 and greater.
  4. * Subjects with current or prior infection of the ipsilateral shoulder.
  5. * Subjects with known hypersensitivity to bovine-derived materials.
  6. * Subjects with known inflammatory arthropathy, history of inflammatory arthropathy, chronic joint disease or chronic pain of upper extremities (shoulder(s), arm(s)).
  7. * Subjects with prior shoulder surgery on index shoulder, including subacromial decompression, biceps tenodesis/tenotomy, and acromioclavicular joint (ACJ) excision/distal clavicle excision (DCE).
  8. * Subjects with a planned surgery on the contra-lateral shoulder within the study period.
  9. * Systemic steroid use (oral, IV) or local steroid injection within 3 months of the date of surgery.
  10. * Subjects with a full thickness rotator cuff tear.
  11. * Subjects with a subscapularis tear requiring repair.
  12. * Subjects requiring a concomitant labral fixation procedure, concomitant surgery for bone defects requiring bone implantation or for superior labral tear from anterior to posterior (SLAP).
  13. * Subjects requiring a concomitant os acromiale fixation procedure.
  14. * Subjects with glenohumeral joint instability (multiple dislocations/subluxations).
  15. * Subjects with condition(s) that contraindicate or complicate outcomes of Isolated Bioinductive Repair or completion and repair e.g., \> Hamada 3 rotator cuff arthropathy on X-ray, Goutallier atrophy \> Grade 3, proximal humeral fracture or scapular fracture, avascular necrosis of the humeral head.
  16. * Subjects with neurologic conditions effecting either upper extremity.
  17. * Subjects who are unable to tolerate magnetic resonance imaging (MRI), due to psychiatric or medical contraindications.
  18. * Subjects who are pregnant or breast feeding.
  19. * Subjects who are currently involved in any injury litigation relating to the index shoulder.
  20. * Subjects with current workers compensation claim.
  21. * Subjects who are enrolled, or plan to enroll, in another clinical trial during this study that would affect the outcomes of this study.
  22. * Subjects with a history of poor compliance with medical treatment, physical therapy (PT)/rehabilitation, or clinical study participation.
  23. * Subject who, in the opinion of the Investigator, has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, mental retardation, and drug or alcohol abuse.
  24. * Subjects who do not meet the indication or are contraindicated according to specific Smith+Nephew REGENETEN System's Instructions for Use (IFUs).
  25. * Any subject that meets the definition of a Vulnerable Subject per ISO 14155 Section 3.55.
  26. * Subjects who have participated previously in this clinical trial and who have healed or been withdrawn
  27. * Subjects with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.

Contacts and Locations

Study Contact

Judith Horner
CONTACT
+44 (0) 1482673251
Judith.Horner@smith-nephew.com
Mary Ozokwere
CONTACT
+1 469-560-0727
Mary.Ozokwere@smith-nephew.com

Principal Investigator

Laura Mills
STUDY_CHAIR
Smith & Nephew, Inc.

Study Locations (Sites)

Harbin Clinic
Rome, Georgia, 30165
United States
OrthoIllinois LTD
Rockford, Illinois, 61107
United States
Sinai Hospital Baltimore
Baltimore, Maryland, 21215
United States
Cleveland Clinic - Sports Health
Garfield Heights, Ohio, 44125
United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
United States
Texas Orthopedic Specialists
Bedford, Texas, 76021
United States
Houston Methodist The Woodlands
The Woodlands, Texas, 77385
United States
Memorial Medical Center
Ashland, Wisconsin, 54806
United States

Collaborators and Investigators

Sponsor: Smith & Nephew, Inc.

  • Laura Mills, STUDY_CHAIR, Smith & Nephew, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-08-30
Study Completion Date2027-06-30

Study Record Updates

Study Start Date2022-08-30
Study Completion Date2027-06-30

Terms related to this study

Keywords Provided by Researchers

  • Rotator cuff tear
  • High grade partial thickness tears
  • REGENETEN Bioinductive Implant System

Additional Relevant MeSH Terms

  • Rotator Cuff Injuries