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Safety and Performance of the MICRORAPTOR™ REGENESORB™ Suture Anchor in Shoulder and Hip

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ClinicalTrials.gov Identifier: NCT03985839
Recruitment Status : Recruiting
First Posted : June 14, 2019
Last Update Posted : August 19, 2019
Sponsor:
Information provided by (Responsible Party):
Smith & Nephew, Inc.

Brief Summary:
This is a prospective, multi-center, PMCF study to evaluate the safety and performance of the MICRORAPTOR REGENESORB suture anchors implanted in 120 subjects (60 shoulder subjects and 60 hip subjects) needing reattachment of soft tissue to bone.

Condition or disease Intervention/treatment
Labral Tear, Glenoid Acetabular Labrum Tear Device: Microraptor Regenesorb suture anchor

Detailed Description:
The purpose of this trial is to assess safety and performance post-market of the Microraptor Regenesorb Suture Anchors. Approximately 6 sites (approximately 3 sites for study shoulder group and 3 sites for study hip group) in the United States will participate in the study. This is an open-label study with consecutive enrollment. The study will continue for 12 months from the date that the last subject received the study treatment to the date that the last subject completes the study as planned. The study duration is planned for 24 months.

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Prospective Multi-Center Post-Market Clinical Follow-up Study to Evaluate Safety and Performance of the MICRORAPTOR™ REGENESORB™ Suture Anchor in Shoulder and Hip Arthroscopic Instability Repair
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : March 2022

Intervention Details:
  • Device: Microraptor Regenesorb suture anchor
    Smith & Nephew MICRORAPTOR REGENESORB Suture Anchor is a fixation device intended to provide secure attachment of soft tissue to bone


Primary Outcome Measures :
  1. Repair failure rate [ Time Frame: 6 months ]
    To assess repair failure rate at 6 months


Secondary Outcome Measures :
  1. ROWE shoulder score [ Time Frame: 6 and 12 months ]
    ROWE score for shoulder instability is a 3-item instrument completed by the investigator or qualified, delegated study staff. Its questions address the categories of shoulder stability (0 to 50 points), motion (0 to 20 points), and function (0 to 30 points). Scores range from 0 to 100 with a score of 90-100 points indicating an excellent evaluation, 75-89 points indicating a good evaluation, 51-74 points indicating a fair evaluation, and =< 50 points indicating a poor evaluation.

  2. Repair failure rate [ Time Frame: 12 months ]
    To assess repair failure rate at 12 months

  3. WOSI shoulder score [ Time Frame: 6 and 12 months ]
    Western Ontario Shoulder Instability Index (WOSI) is a subject completed instrument. Its categories include "physical symptoms" (10 items), "sports, recreation, work" (4 items), "pain" (4 items), "lifestyle" (4 items), and "emotion" (3 items), with each category scored from 0 to 100 using a visual analog scale. Overall scores range from 0 to 2100 with a score of 0 indicating better shoulder function and 2100 indicating worse shoulder function.

  4. Constant-Murley Shoulder Scale [ Time Frame: 6 and 12 months ]
    Constant-Murley Shoulder (CMS) scale assesses four aspects related to shoulder pathology; two subjective: pain and activities of daily living (ADL) and two objective: range of motion (ROM) and strength. The subjective components can receive up to 35 points and the objective 65, resulting in a possible maximum total score of 100 points (best function). Pain and ADL are answered by the subject; ROM and strength require a physical evaluation and are answered by the orthopaedic surgeon or the physiotherapist.

  5. HOS-ADL Score [ Time Frame: 6 and 12 months ]
    Hip Outcome Score (HOS) was designed to assess the outcome of treatment intervention for individuals with acetabular tears who may be functioning throughout a wide range of abilities. It is a subject completed measure that consists of an "Activities of Daily Living" (ADL) subscale (17 scored items) and a "Sports" subscale (9 scored items) in which the response options are presented as 5-point Likert scales. Scores for each subscale range from 0% (least function) to 100% (most function).

  6. Modified Harris Hip Score [ Time Frame: 6 and 12 months ]
    Modified Harris Hip Score (mHHS) is a joint specific score that is completed by both the investigator or qualified, delegated study staff and the subject and consists of 10 items covering domains of pain (1 item, 0-44 points), function (7 items, 0-47 points), functional activities, absence of deformity (1 item, 0-4 points), and hip range of motion (2 items, 0-5 points). Scores range from 0 (worse disability) to 100 (less disability).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subject requires reattachment of soft tissue to bone for the following indications:

  • Shoulder - Capsular stabilization for Bankart repair, Anterior shoulder instability, SLAP lesion repairs, Capsular shift or capsulolabral reconstructions; Biceps tenodesis
  • Hip - Acetabular labrum repair/reconstruction
Criteria

Inclusion Criteria:

  • Subject requires reattachment of soft tissue to bone for the following indications: Shoulder - Capsular stabilization for Bankart repair, Anterior shoulder instability, SLAP lesion repairs, Capsular shift or capsulolabral reconstructions; Biceps tenodesis Hip - Acetabular labrum repair/reconstruction

    • Subject has consented to participate in the study by signing the EC-approved informed consent form.
    • Subject is ≥18 years of age at time of surgery.
    • Willing and able to make all required study visits.
    • Able to follow instructions.

Exclusion Criteria:

  • Known hypersensitivity to the implant material. Where material sensitivity is suspected, appropriate tests should be made and sensitivity ruled out prior to implantation.

    • Pathological conditions of bone, such as cystic changes or severe osteopenia, which would compromise secure anchor fixation.
    • Pathological conditions in the soft tissues to be attached that would impair secure fixation by suture.
    • Comminuted bone surface, which would compromise secure anchor fixation.
    • Physical conditions which would eliminate, or tend to eliminate, adequate anchor support or retard healing.
    • The presence of infection.
    • Conditions which would limit the subject's ability or willingness to restrict activities or follow directions during the healing period.
    • Currently using tobacco products (cigarette, smokeless tobacco, ecigarettes, vaping etc.).
    • Concurrent bilateral surgery.
    • Prior MICRORAPTOR REGENESORB implantation.
    • Participation in the treatment period of another clinical trial within thirty (30) days of Visit 1, or during the study.
    • Women who are pregnant, nursing, or of child-bearing potential who are not utilizing highly effective birth control measures.
    • History of poor compliance with medical treatment.
    • Prior ipsilateral surgeries performed on the joint space.
    • Subjects with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03985839


Contacts
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Contact: Timothy Richardson 678-630-9948 timothy.richardson@smith-nephew.com
Contact: Rachel Nelson 571-595-5772 Rachel.Nelson@smith-nephew.com

Locations
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United States, Colorado
Colorado Springs Orthopaedic Group Recruiting
Colorado Springs, Colorado, United States, 80920
Contact: Jennifer Wages, PhD    719-632-7669    JWages@csog.net   
Principal Investigator: Michael Huang, MD         
Sponsors and Collaborators
Smith & Nephew, Inc.
Investigators
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Study Chair: Beate Hanson, MD, PhD Smith & Nephew, Inc.

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Responsible Party: Smith & Nephew, Inc.
ClinicalTrials.gov Identifier: NCT03985839     History of Changes
Other Study ID Numbers: 2018.20.SMD.MRPTKT.PRO
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: August 19, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Smith & Nephew, Inc.:
Microraptor, suture anchor, knotted, Smith and Nephew

Additional relevant MeSH terms:
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Rotator Cuff Injuries
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries