superior capsular reconstructions
Conditions
Interventions
All subjects will undergo a superior capsular reconstruction (SCR).
Sponsors
St. Antonius Ziekenhuis
Eligibility
Inclusion criteria
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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Contacts
Public ContactNienke Wolterbeek
Afdeling Orthopedie St. Antonius Ziekenhuis Postbus 2500
Outcome results
None listed