Clinical trial NCT05721560: SINEFIX-2022 Pilot Phase
Official title: Pre-market Clinical Investigation Inovedis SINEFIX
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Rotator Cuff Tears (RCTs)
Lead sponsor: BAAT Medical Products B.V.
Sponsor class: INDUSTRY
First posted: 2023-02-10
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pilot phase: single-arm prospective non-comparative single-centre study phase
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Healing integrity
timeFrame: 3 months post operation
measure: Re-tear rate
timeFrame: 3 months post operation
measure: Dislocation of the implant
timeFrame: 3 months post operation
measure: Bursitis
timeFrame: 3 months post operation
Secondary outcomes:
measure: Surgery time
timeFrame: Immediately post procedure
measure: Usability and workflow assessment
timeFrame: Immediately post procedure
measure: Functional and clinical outcome after rotator cuff repair
timeFrame: At 6 months, 1 and 2 years follow-up
measure: Functional and clinical outcome after rotator cuff repair as compared with baseline
timeFrame: At 6 months, 1 and 2 years follow-up
measure: Shoulder function after rotator cuff repair (subjective evaluation)
timeFrame: At 10 weeks, 6, 12, and 24 months
measure: Shoulder function after rotator cuff repair (physical examination-active external rotation)
timeFrame: At 10 weeks, 6, 12, and 24 months
measure: Shoulder function after rotator cuff repair (physical examination-active anteversion)
timeFrame: At 10 weeks, 6, 12, and 24 months
measure: Healing integrity
timeFrame: At 6, 12, and 24 months
measure: Re-tear rate
timeFrame: At 6, 12, and 24 months
measure: Dislocation of the implant
timeFrame: At 6, 12, and 24 months
measure: Bursitis
timeFrame: At 6, 12, and 24 months
measure: Complications
timeFrame: During the follow up time (up to 24 months)
measure: Patient satisfaction
timeFrame: At 10 weeks, 6, 12, 24 months
measure: Safety endpoint
timeFrame: During the intervention and the follow up time (up to 24 months)
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: Orthopädisch Chirurgisches Centrum (OCC)
Study officials:
References: