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
|Condition or disease||Intervention/treatment|
|Labral Tear, Glenoid Acetabular Labrum Tear||Device: Microraptor Regenesorb suture anchor|
|Study Type :||Observational|
|Estimated Enrollment :||120 participants|
|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|
- 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
- Repair failure rate [ Time Frame: 6 months ]To assess repair failure rate at 6 months
- 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.
- Repair failure rate [ Time Frame: 12 months ]To assess repair failure rate at 12 months
- 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.
- 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.
- 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).
- 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).
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
|Contact: Timothy Richardsonfirstname.lastname@example.org|
|Contact: Rachel Nelson||571-595-5772||Rachel.Nelson@smith-nephew.com|
|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|
|Study Chair:||Beate Hanson, MD, PhD||Smith & Nephew, Inc.|