SINEFIX-2022 Pilotfase
Pre-market klinisch onderzoek Inovedis SINEFIX
Shoulder pain is one of the most commonly reported musculoskeletal complaints, which negatively affects upper limb use, night rest, daily life activities, work, sports performance and autonomy. Rotator cuff disease represents the most common cause of shoulder pain and it is responsible for up to 70% of all shoulder related visits to clinicians. Its incidence furthermore is expected to grow as the population ages. A wide range of conditions are included under the umbrella term of rotator cuff disease, including rotator cuff tendinopathy, subacromial bursal pathology, and partial-thickness or full-thickness rotator cuff tears (RCTs). The latter ones, i.e. rotator cuff tears, form the indications for which the test devices, the SINEFIX implant and instruments, are intended.
Despite the high prevalence of this condition, the pathophysiology and healing potential are not well understood, making the condition challenging to predictably treat in some patient populations. RCTs may occur in young people as a consequence of trauma (e.g. acute shoulder dislocation), however RCTs typically present in middle-aged or elderly people and cannot always be attributed to precipitating events or trauma. Instead, they can be attributed to degenerative processes, and are therefore referred to as degenerative RCTs.
For RCTs, treatment options include both surgical and non-surgical (conservative) procedures.
In this context, the SINEFIX implant and instruments were developed to treat adult patients with rotator cuff lesions of size up to 2 cm through arthroscopic reconstruction.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Tübingen, Duitsland, 72074
- Orthopädisch Chirurgisches Centrum (OCC)
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Patient indicated for surgical repair of the rotator cuff tear according to current guidelines
- Patient aged 18 years or older
- Up to 2 cm tear size of supraspinatus, infraspinatus (medio-lateral)
- Up to 2 cm tear size of supraspinatus, infraspinatus (anterior-posterior)
Exclusion Criteria:
- Subject has had previous rotator cuff, arthroplasty or fracture procedures on the operative shoulder
- History of alcoholism, drug abuse, psychological or other emotional problems likely to interfere with participation in the study follow-up schedule and assessments
- Inflammatory arthropathies
- Subject with a contraindication/non-compliance for MRI examination
- Subject 's unwillingness to undergo surgical rotator cuff repair, participate in post-operative rehabilitation program, and / or adhere to follow up schedule
- Pregnant and breastfeeding woman
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: SINEFIX
Rotator cuff repair with the SINEFIX implant, using the SINEFIX instruments |
Treatment of rotator cuff lesions of size up to 2 cm using the SINEFIX implant and instruments |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Healing integrity
Tijdsspanne: 3 months post operation
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Healing integrity will be assessed with the MRI by evaluating the visibility of the tendon underneath the implant (yes/no) |
3 months post operation
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Re-tear rate
Tijdsspanne: 3 months post operation
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Re-tear rate will be assessed with MRI |
3 months post operation
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Dislocation of the implant
Tijdsspanne: 3 months post operation
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Presence of dislocation of the implant will be assessed with MRI (yes/no) |
3 months post operation
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Bursitis
Tijdsspanne: 3 months post operation
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Presence of bursitis will be assessed with MRI (yes/no) |
3 months post operation
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Surgery time
Tijdsspanne: Immediately post procedure
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The total procedure duration will be recorded as the surgery time |
Immediately post procedure
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Usability and workflow assessment
Tijdsspanne: Immediately post procedure
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Usability and workflow assessment will be evaluated after each intervention through a practitioner's questionnaire covering different aspects of the implant and instruments |
Immediately post procedure
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Functional and clinical outcome after rotator cuff repair
Tijdsspanne: At 6 months, 1 and 2 years follow-up
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Functional and clinical outcome after rotator cuff repair will be assessed using the total Constant Murley score, which ranges from 0 (worst outcome) to 100 (best outcome) |
At 6 months, 1 and 2 years follow-up
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Functional and clinical outcome after rotator cuff repair as compared with baseline
Tijdsspanne: At 6 months, 1 and 2 years follow-up
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Functional and clinical outcome after rotator cuff repair will be assessed using the change of the total Constant Murley score (range 0-100) as compared to baseline |
At 6 months, 1 and 2 years follow-up
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Shoulder function after rotator cuff repair (subjective evaluation)
Tijdsspanne: At 10 weeks, 6, 12, and 24 months
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Shoulder function after rotator cuff repair (subjective evaluation) will be assessed through the Subjective Shoulder Value (SSV) which ranges from 0% to 100% (best outcome) |
At 10 weeks, 6, 12, and 24 months
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Shoulder function after rotator cuff repair (physical examination-active external rotation)
Tijdsspanne: At 10 weeks, 6, 12, and 24 months
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Shoulder function after rotator cuff repair (physical examination) will be assessed through a physical examination with assessment of range of motion for active external rotation (range 0°-90°) |
At 10 weeks, 6, 12, and 24 months
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Shoulder function after rotator cuff repair (physical examination-active anteversion)
Tijdsspanne: At 10 weeks, 6, 12, and 24 months
|
Shoulder function after rotator cuff repair (physical examination) will be assessed through a physical examination with assessment of range of motion for active anteversion (0°-180°) |
At 10 weeks, 6, 12, and 24 months
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|
Healing integrity
Tijdsspanne: At 6, 12, and 24 months
|
Healing integrity will be assessed with the MRI by evaluating the visibility of the tendon underneath the implant (yes/no) |
At 6, 12, and 24 months
|
|
Re-tear rate
Tijdsspanne: At 6, 12, and 24 months
|
Re-tear rate will be assessed with MRI |
At 6, 12, and 24 months
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Dislocation of the implant
Tijdsspanne: At 6, 12, and 24 months
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Presence of dislocation will be assessed with MRI (yes/no) |
At 6, 12, and 24 months
|
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Bursitis
Tijdsspanne: At 6, 12, and 24 months
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Presence of bursitis will be assessed with MRI (yes/no) |
At 6, 12, and 24 months
|
|
Complications
Tijdsspanne: During the follow up time (up to 24 months)
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Complications will be systematically reported. Complications of particular interest for the purpose of the study are neurological problems, bleeding, impaired wound healing, infection and frozen shoulder. |
During the follow up time (up to 24 months)
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Patient satisfaction
Tijdsspanne: At 10 weeks, 6, 12, 24 months
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The patient will be asked to rate his/her satisfaction with outcome of the surgical repair (0=completely unsatisfied, 1=unsatisfied, 2=satisfied, 3=completely satisfied) |
At 10 weeks, 6, 12, 24 months
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Safety endpoint
Tijdsspanne: During the intervention and the follow up time (up to 24 months)
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Safety of the device will be evaluated by systematically reporting device deficiencies (DDs), adverse events (AEs) and serious adverse events (SAEs) and by monitoring the frequency and incidence of these events |
During the intervention and the follow up time (up to 24 months)
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- SINEFIX-2022
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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