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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Treatment of rotator cuff lesions of size up to 2 cm using the SINEFIX implant and instruments
Orthopädisch Chirurgisches Centrum (OCC)
Tübingen, Germany
Healing integrity
Healing integrity will be assessed with the MRI by evaluating the visibility of the tendon underneath the implant (yes/no)
Time frame: 3 months post operation
Re-tear rate
Re-tear rate will be assessed with MRI
Time frame: 3 months post operation
Dislocation of the implant
Presence of dislocation of the implant will be assessed with MRI (yes/no)
Time frame: 3 months post operation
Bursitis
Presence of bursitis will be assessed with MRI (yes/no)
Time frame: 3 months post operation
Surgery time
The total procedure duration will be recorded as the surgery time
Time frame: Immediately post procedure
Usability and workflow assessment
Usability and workflow assessment will be evaluated after each intervention through a practitioner's questionnaire covering different aspects of the implant and instruments
Time frame: Immediately post procedure
Functional and clinical outcome after rotator cuff repair
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)
Time frame: At 6 months, 1 and 2 years follow-up
Functional and clinical outcome after rotator cuff repair as compared with baseline
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
Time frame: At 6 months, 1 and 2 years follow-up
Shoulder function after rotator cuff repair (subjective evaluation)
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)
Time frame: At 10 weeks, 6, 12, and 24 months
Shoulder function after rotator cuff repair (physical examination-active external rotation)
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°)
Time frame: At 10 weeks, 6, 12, and 24 months
Shoulder function after rotator cuff repair (physical examination-active anteversion)
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°)
Time frame: At 10 weeks, 6, 12, and 24 months
Healing integrity
Healing integrity will be assessed with the MRI by evaluating the visibility of the tendon underneath the implant (yes/no)
Time frame: At 6, 12, and 24 months
Re-tear rate
Re-tear rate will be assessed with MRI
Time frame: At 6, 12, and 24 months
Dislocation of the implant
Presence of dislocation will be assessed with MRI (yes/no)
Time frame: At 6, 12, and 24 months
Bursitis
Presence of bursitis will be assessed with MRI (yes/no)
Time frame: At 6, 12, and 24 months
Complications
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.
Time frame: During the follow up time (up to 24 months)
Patient satisfaction
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)
Time frame: At 10 weeks, 6, 12, 24 months
Safety endpoint
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
Time frame: During the intervention and the follow up time (up to 24 months)
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