Rotator Cuff Injury
Conditions
Keywords
rotator cuff, biceps, long biceps tendon
Brief summary
The aim of this study is to compare the clinical results and complications of self-locking biceps tenodesis and double 360 lasso loop biceps tenodesis for the treatment of long chief of biceps or superior labrum anterior-posterior (SLAP) tendon pathology during shoulder arthroscopy in patients undergoing arthroscopic rotator cuff repair. 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. 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. Given its potential advantages, self-locking biceps tenodesis could emerge as 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 to choose the most appropriate treatment for their patients suffering from long biceps tendon pathology.
Interventions
PROCEDUREself-blocking tenodesis
the LHB tendon is detached from its origin in 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 later localization of the LHB tendon during imaging (3-0 stainless steel, ethicon).
PROCEDUREarthroscopic tenodesis
LHB tendon is detached from its origin, and sutured. Next, the LHB tendon is fixed in the bicipital groove using a 360-lasso loop tenodesis technique. 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
* Rotator cuff tear: confirmed preoperative diagnosis of a non- traumatic, full- thickness tear of the supraspinatus and/or infraspinatus and/or subscapularis tendon, as evidenced by ultrasound, arthro- CT or MRI. * Language proficiency: sufficient to allow for communication during the informed consent process and for the completion of the study questionnaires.
Exclusion criteria
* Tear type: partial thickness rotator cuff tears are excluded. * Tear severity: individuals with massive or irreparable rotator cuff tears are excluded. * Fatty degeneration: presence of rotator cuff muscle fatty degeneration classified as Grade 4 according to the Goutallier system will result in exclusion. * Glenohumeral osteoarthritis: patients exhibiting glenohumeral osteoarthritis, defined radiographically by the presence of joint space narrowing or osteophytes on anteroposterior (radiographs of the affected shoulder) will be excluded. * Prior shoulder surgery: history of previous surgical intervention on the affected shoulder will result in exclusion. * Popeye sign: preoperative presence of the Popeye sign will result in exclusion. * Cognitive impairment: pre- existing dementia or any condition that impairs the ability to understand study procedures and complete questionnaires and assessments is an exclusion criterion. * Pregnant, parturient or breast-feeding patients. * Persons under legal protection (curatorship, guardianship, safeguard of justice). * Persons deprived of their liberty by judicial or administrative measure * Persons under psychiatric care * Persons not affiliated to a social security scheme
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Constant score (CMS) | 1 year after surgery | The CMS is a 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, there 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 | 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