SLAP Lesion
Conditions
Keywords
biceps, tenodesis, imaging, tendon repair
Brief summary
This is a prospective randomized controlled trial. The aim of this study is to compare the clinical results and complications of self-locking biceps tenodesis and double-loop 360 lasso biceps tenodesis for the treatment of pathology of the long head of the biceps or superior labrum anterior-posterior (SLAP) during shoulder arthroscopy in patients without arthroscopic rotator cuff tears. Currently, there is no consensus on the use of tenodesis versus tenotomy to treat pathology of the long head of the biceps during arthroscopic rotator cuff repair. Numerous studies have examined the clinical results of long biceps tenotomy versus long biceps tenodesis, and there is no evidence to date of superiority of either technique. However, these studies were carried out on patients with rotator cuff tears, and so it has not been possible to directly compare the two procedures. At Clinique Générale, we use a new, innovative technique called autobloc tenodesis to treat pathologies of the long head of the biceps. There are no comparative studies between autobloc tenodesis of the biceps and biceps tenodesis in patients without rotator cuff tears. Given its potential advantages, autobloc biceps tenodesis could become the new technique of choice for treating biceps longus tendon pathology, potentially reducing differences in outcomes such as Popeye deformity. The information provided by this study could potentially guide future clinical practice, helping surgeons choose the most appropriate treatment for their patients with long biceps tendon pathology.
Interventions
PROCEDUREself-locking biceps tenodesis
The LHB tendon is detached from its origin at the level of the superior labrum. This technique supports the self-locking mechanism of the LHB tendon in the bicipital groove by detaching the tendon from the Y-shaped superior glenoid, including the superior labrum. A radiographically visible suture will be attached to the proximal part of the LHB tendon to facilitate subsequent localization of the LHB tendon during imaging (3-0 stainless steel, ethicon).
PROCEDUREBiceps Tenodesis with 360 Suture anchor
The LHB tendon is detached from its origin and sutured. Next, the LHB tendon is fixed in the bicipital groove using a 360-loop tenodesis technique with the Knotless FiberTak® biceps implant system. A radiographically visible suture will be attached to the proximal part of the LHB tendon to facilitate subsequent localization of the LHB tendon during imaging (3-0 stainless steel, ethicon).
Sponsors
Clinique Générale dAnnecy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pathology of the LHBT or SLAP-type lesion based on clinical symptoms * Partial-thickness rupture or absence of full-thickness rupture of the rotator cuff of the subscapular, supraspinatus and/or infraspinatus tendons, diagnosed preoperatively on ultrasound, arthro-CT or MRI
Exclusion criteria
* Full-thickness tears of the rotator cuff diagnosed preoperatively on ultrasound, arthro-CT or MRI. * Osteoarthritis of the glenohumeral joint, defined by narrowing of the glenohumeral joint space or osteophytes, using AP radiography of the affected shoulder. * Previous surgery on the affected shoulder * Patients presenting with motor paralysis of the shoulder * Preoperative presence of the Popeye sign or documented LHBT rupture * Dementia or inability to complete questionnaires and assessments in French or English. * Pregnant or breast-feeding patient * Protected adult patient * Patient not covered by social security.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Constant score | 1 year after surgery | 100-point scale comprising four components, including a patient-reported section (pain 15 points and activity level 20 points), for a total of 35 points. Alongside this is a doctor-reported section (shoulder strength 25 points, range of motion 40 points) for a total of 65 points. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| American Shoulder and Elbow Surgeons Score (ASES) | 6 weeks, 3 months, 6 months, 1 year after surgery | The ASES is a 100-point scale comprising 2 assessment dimensions: pain and activities of daily living. |
| Subjective Shoulder Value (SSV) | 6 weeks, 3 months, 6 months, 1 year after surgery | The SSV is a single-question assessment of the patient's perceived shoulder function expressed as a percentage of normal. |
| LHB score | 6 months, 1 year after surgery | The LHB score assesses symptoms and function related to long head of the biceps tendon pathology. |
| cosmetic appearance | 6 weeks, 3 months, 6 months, 1 year after surgery | Cosmetic appearance will be assessed by both the patient and the clinician using standardized photographs. |
| VAS pain score | 6 weeks, 3 months, 6 months, 1 year after surgery | Pain intensity will be assessed using a visual analogue scale (VAS) at rest, during activity, and over the bicipital groove. |
| Radiograph | Direct post-op, 6 weeks, 3 months, 6 months after surgery | Standardized radiographs will assess postoperative migration of the long head of the biceps tendon using a radio-opaque marker. |
| MRI or Ultra-sound | 1 year after surgery | MRI or ultrasound will assess the postoperative position of the long head of the biceps tendon at final follow-up. |
Countries
France
Contacts
CONTACTGeert Alexander Buijze, MD
Outcome results
None listed