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van CCT (UK)

van CCT (UK)

Superior Capsular Reconstruction: A registry study

- candidate number27735
- NTR NumberNTR7625
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-aug-2017
- Secondary IDsNL65778.100.18 
- Public TitleSuperior Capsular Reconstruction: A registry study
- Scientific TitleSuperior Capsular Reconstruction: A registry study
- hypothesisPatients undergoing superior capsule reconstructions (SCR) for superior shoulder instability will experience less pain (decrease of at least 2 points) and improved function.
- Healt Condition(s) or Problem(s) studiedShoulder instability, Rotator cuff, Reconstruction, Shoulder disorders , Superior capsular reconstructions
- 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 criteriaPre-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
- mec approval receivedno
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-nov-2017
- planned closingdate1-nov-2024
- Target number of participants15
- InterventionsAll subjects will undergo a superior capsular reconstruction (SCR).
- Primary outcomeThe 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 outcomeOutcome 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.
- Timepointspre-operative; 3 weeks, 12 weeks, 6 months, 1 year, 2 years, 5 years post-operatively
- Trial web site
- statusplanned
- Sponsor/Initiator St. Antonius Hospital
- Funding
(Source(s) of Monetary or Material Support)
St Antonius Hospital, Nieuwegein
- Publications-
- Brief summaryThe 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
- Main changes (audit trail)
- RECORD11-aug-2017 - 30-nov-2018

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