No registrations found.
ID
Source
Brief title
Health condition
superior capsular reconstructions; shoulder; instability; rotator cuff; kapselreconstructie; cuff scheur; schouder instabiliteit
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome will be change in pain score (Numeric Rating Scale: 0-10) at 1 year after surgery. A decrease of 2 points in pain is considered to be a clinical relevant decrease. A decrease in pain is expected from 12 weeks on, although patients will not be fully functional and are still in their rehabilitation process until one year after surgery.
Secondary outcome
Outcome measures will be assessed through validated outcomes scoring systems. Secondary outcomes include function measured by the Constant Murley Score (CMS), the American Shoulder and Elbow Score Objective Score (ASES objective), RAND 12-Item Health Survey (RAND-12), Single Assessment Numeric Evaluation score (SANE), American Shoulder and Elbow Score subjective score, (ASES subjective) and the Western Ontario Rotator Cuff (WORC) index. In addition, MRI will be utilized to assess the status of the remaining rotator cuff tendons and SCR (healing versus non-healing). Ultrasound will be utilized to assess the thickness of the graft as compared to pre-op thickness and vascularization of the graft. Standard radiographs will be utilized assess the acromiohumeral interval and level of arthritic change as measured by the Hamada scale. Adverse event information will be documented as occurs. The following table outlines the outcome measures and time points for data collection. All follow-up moments are regular care, however, at every follow-up moment, extra data will be collected.
Background summary
The purpose of this study is to determine if patients with irreparable supraspinatus tears who receive a dermal Extracellular Matrix to reconstruct the superior capsule during arthroscopic rotator cuff repairs have improved functional and clinical outcomes. This concerns a observational register study focused on superior capsular reconstruction
Study objective
Patients undergoing superior capsule reconstructions (SCR) for superior shoulder instability will experience less pain (decrease of at least 2 points) and improved function.
Study design
pre-operative; 3 weeks, 12 weeks, 6 months, 1 year, 2 years, 5 years post-operatively
Intervention
All subjects will undergo a superior capsular reconstruction (SCR).
St. Antonius Ziekenhuis<br>
Postbus 2500
Nienke Wolterbeek
Nieuwegein 3430 EM
The Netherlands
orthopedie-research@antoniusziekenhuis.nl
St. Antonius Ziekenhuis<br>
Postbus 2500
Nienke Wolterbeek
Nieuwegein 3430 EM
The Netherlands
orthopedie-research@antoniusziekenhuis.nl
Inclusion criteria
• Subjects that have consented to implantation of allograft tissue
• Adult patients (≥18 year)
• Subjects who are candidates and planning to undergo arthroscopic SCR for irreparable supraspinatus tears
• Pre-operative MRI obtained within 26 weeks prior to surgery
• Must have 3 out of 5 points on MRC scale for external rotation strength (Appendix I)
• Must have intact teres minor
Exclusion criteria
Pre-Op exclusion criteria
• Pregnant or planning to become pregnant
• Persons with a mental or cognitive disability deemed significant enough that they would not be capable of completing the outcome measures
• Patients with known contraindications to MRI
• Greater than 20 degrees loss of passive range of motion (ROM) compared to the contralateral side
• Grade 4 or 5 Hamada classification
• Pectoralis major, Deltoid, or Latissimus dorsi dysfunction
• Acute fractures of humerus, clavicle or scapula
• Intra-articular injections (steroids) within 1 month of surgery
• Inability to speak and understand Dutch
Intra-Op Exclusion
• Damaged coracoacromial ligament
• Unable to fixate the graft on the humeral side utilizing a double row SpeedBridge repair
• Inability to address subscapularis pathology
• Diffuse bipolar cartilage loss
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL6756 |
NTR-old | NTR7625 |
CCMO | NL65778.100.18 |