Embody Post-Market Clinical Follow-Up Study

Launched by ZIMMER BIOMET · Feb 16, 2023

Keywords

ClinConnect Summary

This is a multi-center, forward-looking registry that follows adults undergoing shoulder replacement who will have a subscapularis tendon repair augmented with the TAPESTRY Biointegrative Implant. The main goal is to see if the repaired tendon stays intact at 6 months after surgery, as checked by ultrasound. Researchers will also look at shoulder function (like strength), safety, and patient-reported outcomes over time, with plans to follow participants for up to 24 months and enroll about 100 people.

Eligible participants are adults 21 years and older who need a shoulder replacement and will have a subscapularis repair using the TAPESTRY implant, assuming they meet health and rehab requirements. Key exclusions include poorly controlled diabetes, inflammatory or immune conditions, certain prior shoulder issues, pregnancy, and other factors. Participants will have visits before surgery and at 3, 6, 12, and 24 months after, including ultrasound checks, strength and range-of-motion tests, and questionnaires about pain and daily function. The study is sponsored by Zimmer Biomet and conducted at several U.S. sites, with the intention of comparing repair failure rates to those reported in the medical literature, while carefully monitoring safety and any adverse events.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Adult, 21 years and older.
• • 2. Patient requires shoulder arthroplasty (anatomic or reverse) with subscapularis repair due to osteoarthritis, rotator cuff injury, rheumatoid arthritis and/or other inflammatory disorder, osteonecrosis, and/or post-traumatic injury (e.g., humerus fractures).
• • 3. Patients healthy enough to undergo primary anatomic or reverse shoulder arthroplasty, in the opinion of the investigator;
• • 4. Patients receiving shoulder arthroplasty with anticipated subscapularis tenotomy (ST) or subscapularis peel (SP).
• • 5. Intact rotator cuff including subscapularis tendon for anatomic shoulder arthroplasty or a repairable subscapularis tendon for reverse shoulder arthroplasty, as determined by preoperative examination or imaging, if indicated or available preoperatively. Imaging is not required for this assessment.
• • 6. Ability and willingness to comply with prescribed post-operative rehabilitation program.
• • 7. Ability and willingness to comply with follow-up visit schedule.
• • 8. Able to understand the informed consent process, including regulatory requirements such as HIPAA authorization, and document informed consent prior to completion of any study-related procedures.
• • 9. Ability to read, understand, and complete subject-reported outcomes in English.
• Exclusion Criteria:
• • 1. Shoulder arthroplasty requiring a lesser tuberosity osteotomy or revision arthroplasty.
• • 2. Prior index shoulder surgery requiring treatment to the subscapularis.
• • 3. Intraoperative identification of irreparable subscapularis tear (rTSA)
• • 4. Diabetic patients with hemoglobin A1c (HbA1c) level \>8% prior to surgery.
• • 5. Patients with inflammatory arthritis or patients that are immunocompromised, or patients that have a glenoid deficiency.
• • 6. Patients with a known history of hypersensitivity to bovine-derived materials.
• • 7. Hypersensitivity to poly(D,L-lactide) materials.
• • 8. Females of child-bearing potential who are pregnant or plan to become pregnant during the course of the study.
• • 9. Currently involved in any injury litigation or worker's compensation claims relating to the index shoulder.
• • 10. Enrolled, or plans to enroll, in another clinical trial during this study that would affect the outcomes of this study.
• • 11. History of non-compliance with medical treatment, physical therapy/rehabilitation, or clinical study participation.