Patients undergoing superior capsule reconstructions (SCR) for superior shoulder instability will experience less pain (decrease of at least 2 points) and improved function.
ID
Bron
Verkorte titel
Aandoening
superior capsular reconstructions; shoulder; instability; rotator cuff; kapselreconstructie; cuff scheur; schouder instabiliteit
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
Achtergrond van het onderzoek
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
Doel van het onderzoek
Patients undergoing superior capsule reconstructions (SCR) for superior shoulder instability will experience less pain (decrease of at least 2 points) and improved function.
Onderzoeksopzet
pre-operative; 3 weeks, 12 weeks, 6 months, 1 year, 2 years, 5 years post-operatively
Onderzoeksproduct en/of interventie
All subjects will undergo a superior capsular reconstruction (SCR).
Publiek
St. Antonius Ziekenhuis<br>
Postbus 2500
Nienke Wolterbeek
Nieuwegein 3430 EM
The Netherlands
orthopedie-research@antoniusziekenhuis.nl
Wetenschappelijk
St. Antonius Ziekenhuis<br>
Postbus 2500
Nienke Wolterbeek
Nieuwegein 3430 EM
The Netherlands
orthopedie-research@antoniusziekenhuis.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
• 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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL6756 |
| NTR-old | NTR7625 |
| CCMO | NL65778.100.18 |