Rotator Cuff Tears of the Shoulder
Conditions
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. 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.
Interventions
Treatment of rotator cuff lesions of size up to 2 cm using the SINEFIX implant and instruments
DEVICERotator cuff repair with comparator device
Treatment of rotator cuff lesions with the conventional surgical technique (comparator device)
Sponsors
BAAT Medical Products B.V.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 (medio-lateral) of supraspinatus, infraspinatus * Up to 2 cm tear size (anterior-posterior) of supraspinatus, infraspinatus
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional and clinical outcome after rotator cuff repair as compared with baseline | 1 year post operation | 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)) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgery time | Immediately post procedure | The total procedure duration will be recorded as the surgery time |
| Functional and clinical outcome after rotator cuff repair | At 6 months, 1 and 2 years follow-up | 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)) |
| Functional and clinical outcome after rotator cuff repair as compared with baseline | At 6 months and 2 years follow-up | 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)) |
| Shoulder function after rotator cuff repair (subjective evaluation) | At 10 weeks, 6, 12, and 24 months | Shoulder function after rotator cuff repair will be assessed through the Subjective Shoulder Value (SSV) which ranges from 0% to 100% (best outcome) |
| Shoulder function after rotator cuff repair (physical examination-active external rotation) | 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 external rotation (range 0°-90°) |
| Shoulder function after rotator cuff repair (physical examination-active anteversion) | 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°) |
| Healing integrity | 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) |
| Re-tear rate | At 6, 12, and 24 months | Re-tear rate will be assessed with MRI |
| Dislocation of the implant | At 6, 12, and 24 months | Presence of dislocation will be assessed with MRI (yes/no) |
| Bursitis | At 6, 12, and 24 months | Presence of bursitis will be assessed with MRI (yes/no) |
| Complications | During the follow up time (up to 24 months) | 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. |
| Patient satisfaction | At 10 weeks, 6, 12, 24 months | 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) |
Countries
Germany
Contacts
CONTACTTess Van Dam
CONTACTPhilip Kasten, Prof. Dr.
Outcome results
None listed