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. A pilot study phase investigating the SINEFIX implant and instruments was conducted and showed adequate performance, usability and preliminary safety. Hence, the device is now being tested on a larger number of participants as part of the comparative study phase.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
Treatment of rotator cuff lesions of size up to 2 cm using the SINEFIX implant and instruments
Treatment of rotator cuff lesions with the conventional surgical technique (comparator device)
Kreiskrankenhaus Mechernich GmbH (KKHM)
Mechernich, Germany
RECRUITINGOrthopädisch Chirurgisches Centrum (OCC)
Tübingen, Germany
RECRUITINGFunctional and clinical outcome after rotator cuff repair as compared with baseline
Functional and clinical outcome after rotator cuff repair will be assessed using the increase in total Constant Murley score at 1 year follow-up compared with baseline (range 0 (worst outcome) -100 (best outcome))
Time frame: 1 year post operation
Surgery time
The total procedure duration will be recorded as the surgery time
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 at 6 months, 1 and 2 years follow-up (range 0 (worst outcome) -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 increase in total Constant Murley score at 6 months and 2 years compared with baseline (range 0 (worst outcome) - 100 (best outcome))
Time frame: At 6 months and 2 years follow-up
Shoulder function after rotator cuff repair (subjective evaluation)
Shoulder function after rotator cuff repair 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
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