This is a prospective, multi-center, PMCF study to evaluate the safety and performance of the MICRORAPTOR REGENESORB suture anchors, MICRORAPTOR Knotless REGENESORB suture anchors, and MICRORAPTOR Knotless PEEK suture anchors implanted in 300 subjects needing reattachment of soft tissue to bone.
The purpose of this trial is to assess, by product, safety and performance post-market of the Microraptor Regenesorb, Microraptor Knotless Regenesorb, and Microraptor Knotless PEEK Suture Anchors. Approximately 18 sites (approximately 3 sites for study shoulder group and 3 sites for study hip group, per product) in the United States will participate in the study. This is an open-label study with consecutive enrollment. The study will continue for 24 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 36 months.
Study Type
OBSERVATIONAL
Enrollment
299
Smith \& Nephew MICRORAPTOR™ REGENESORB™ Suture Anchor is a fixation device intended to provide secure attachment of soft tissue to bone.
MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor is fixation device, which consists of an anchor on an inserter, and a suture threader. The anchor consists of the following components: a proximal anchor body (REGENESORB™), and a non-absorbable PEEK (Polyether ether ketone) distal anchor tip.
The MICRORAPTOR™ Knotless PEEK Suture Anchor is a class IIb device, which consists of an anchor on an inserter, and a suture threader. The anchor consists of the following components: a proximal anchor body (PEEK), and a non-absorbable PEEK distal anchor tip.
University of Colorado
Aurora, Colorado, United States
Colorado Springs Orthopaedic Group
Colorado Springs, Colorado, United States
Holy Cross Orthopedic Institute
Oakland Park, Florida, United States
Repair failure rate
To assess repair failure rate at 6 months
Time frame: 6 months
Repair failure rate
To assess repair failure rate at 12 months
Time frame: 12 months
ROWE shoulder score
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.
Time frame: 6 and 12 months
WOSI shoulder score
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.
Time frame: 6 and 12 months
Constant-Murley Shoulder Scale
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.
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Emory University - Brookhaven
Brookhaven, Georgia, United States
Luminis Health Research Institute
Annapolis, Maryland, United States
Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Oklahoma Sports and Science Orthopedics / The Physician's Group
Oklahoma City, Oklahoma, United States
Palmetto/Prisma Health - University of South Carolina Orthopaedics
Columbia, South Carolina, United States
Steadman Hawkins Clinic of the Carolinas
Greenville, South Carolina, United States
Atlantic Orthopaedic Specialists
Virginia Beach, Virginia, United States
...and 2 more locations
Time frame: 6 and 12 months
HOS-ADL Score
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).
Time frame: 6 and 12 months
Modified Harris Hip Score
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).
Time frame: 6 and 12 months
Adverse Events (AEs)
All adverse events (AEs) and complications occurring from the time of surgical implantation until study termination or study completion including intraoperative adverse events and complications will be collected and reported.
Time frame: 12 months
Anchor absorption/replacement by bone (Knotless Regenesorb only)
MRI performed to determine anchor absorption/replacement by bone at 6 months and 24 months
Time frame: 6 and 24 months