Rotator Cuff Syndrome Clinical Trial
— BITEOfficial title:
Long Head Biceps Tenodesis or Tenotomy in Arthroscopic Rotator Cuff Repair: An International Multicenter Prospective Randomized Clinical Trial
NCT number | NCT02655848 |
Other study ID # | WO 10.087 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 2012 |
Est. completion date | September 2019 |
Verified date | September 2019 |
Source | Onze Lieve Vrouwe Gasthuis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
During arthroscopic rotator cuff (infraspinatus/supraspinatus) repair, biceps tendon lesions are frequently encountered. However, the most optimal treatment of the diseased long head of the biceps (LHB) tendon during rotator cuff repair remains a topic of debate: tenotomy or tenodesis. The hypothesis is that there is no difference in functional outcome between LHB tenotomy and LHB tenodesis when performed in adjunct to arthroscopic rotator cuff repair.
Status | Completed |
Enrollment | 98 |
Est. completion date | September 2019 |
Est. primary completion date | September 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 50 Years and older |
Eligibility |
Inclusion Criteria: - Patients older than 50 years - Degenerative rotator cuff lesion of supraspinatus/infraspinatus tendon, smaller than three centimeter. - Patients need to be able to read and write in Dutch or English language in order to complete the questionnaires, and sign informed consent. Exclusion Criteria: - Acute, traumatic or partial thickness rotator cuff rupture, or in case a full thickness tear is larger than 3 cm measured using an arthroscopic ruler. - Accompanying subscapularis tendon lesion - Hour-glass deformation bicepstendon origin or in case of accompanying subscapularis tendon rupture. - Osteoarthritis of the glenohumeral joint - Acromion to humeral head distance measuring 6mm or smaller. - Prior surgery to the involved shoulder - Dementia or inability to complete questionnaires and assessments |
Country | Name | City | State |
---|---|---|---|
Netherlands | Kliniek De Lairesse | Amsterdam | |
Netherlands | OLVG | Amsterdam | |
Netherlands | Slootervaart ziekenhuis | Amsterdam | |
Netherlands | Gelre ziekenhuis | Apeldoorn | |
Netherlands | Amphia ziekenhuis | Breda | |
Netherlands | Groene Hart Ziekenhuis | Gouda | |
Netherlands | Tergooi Ziekenhuizen | Hilversum | |
Netherlands | Spaarne Ziekenhuis | Hoofddorp | |
Netherlands | St Antonius | Nieuwegein | |
Netherlands | Canisius Wilehelmina Zkh | Nijmegen |
Lead Sponsor | Collaborator |
---|---|
Onze Lieve Vrouwe Gasthuis | Nederlandse Vereniging voor Arthroscopie, Smith & Nephew, Inc. |
Netherlands,
Galasso O, Gasparini G, De Benedetto M, Familiari F, Castricini R. Tenotomy versus tenodesis in the treatment of the long head of biceps brachii tendon lesions. BMC Musculoskelet Disord. 2012 Oct 22;13:205. doi: 10.1186/1471-2474-13-205. — View Citation
Gurnani N, van Deurzen DF, Janmaat VT, van den Bekerom MP. Tenotomy or tenodesis for pathology of the long head of the biceps brachii: a systematic review and meta-analysis. Knee Surg Sports Traumatol Arthrosc. 2016 Dec;24(12):3765-3771. Epub 2015 May 15. Review. — View Citation
Zhang Q, Zhou J, Ge H, Cheng B. Tenotomy or tenodesis for long head biceps lesions in shoulders with reparable rotator cuff tears: a prospective randomised trial. Knee Surg Sports Traumatol Arthrosc. 2015 Feb;23(2):464-9. doi: 10.1007/s00167-013-2587-8. Epub 2013 Jul 5. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Shoulder function quantified with the Constant score (0-100) | Sum of the items below: ADL: Patient reported shoulder function during work (0-4), recreation/sports (0-4), and sleep (0-2). Pain: Patient reported pain in the shoulder (severe=0,moderate=5,mild=10,no pain=15). ROM: Anteflexion up to waist(2)/xiphoid process(4)/neck(6)/head(8)/above head(10) Elevation in degrees: 0-30(0)/31-60(2)/61-90(4)/91-120(6)/121-150(8)/151-180(10) Abduction in degrees: 0-30(0)/31-60(2)/61-90(4)/91-120(6)/121-150(8)/151-180(10) External rotation: impossible to reach head with hand(0)/hand behind head-elbow forward(2)/hand behind head-elbow backward(4)/hand on head-elbow forward(6)/hand on head-elbow backward(8)/full elevation hand from head(10) Internal rotation: dorsal part of the hand reaching lateral thigh(0)/buttock(2)/lumbo-sacral junction(4)/L3(6)/Th12(8)/between scapulae(10). Abduction force at 90 degrees in pounds (max. 25) |
1 year | |
Secondary | Popeye phenomenon | Presence of a Popeye deformity in the upper arm (yes/no), as reported by the patient, the treating surgeon, and a blinded assessor. | 1 year | |
Secondary | Cosmetic appearance | Patients will assess cosmetic appearance on a VAS scale. | 1 year | |
Secondary | MRI-based location of the biceps tendon | MRI imaging at 1 year after surgery will be used to assess the location of the proximal biceps tendon. Absence of the biceps tendon in the bicipital groove confirms a successfully performed LHB tenotomy. Absence of the biceps tendon in the bicipital groove confirms failed LHB tendodesis. In addition, the rotator cuff is classified as fully healed, partially healed or recurrent rupture. | 1 year | |
Secondary | Self-reported shoulder function | Patients will complete two validated questionnaires: the Disabilities of Arm, Shoulder and Hand Questionnaire (DASH) and the Dutch Oxford Shoulder Test (DOST) | 1 year | |
Secondary | Pain | Patients will be asked to report if they have pain (yes/no), and to indicate the level of pain on a VAS scale. The VAS scores will be recorded separately for general pain and for pain in the bicipital groove. | 1 year | |
Secondary | Elbow flexion strength | A dynamometer will be used to assess elbow flexion strength with the lower arm in full supination. The Elbow Strength Index is calculated by dividing the strength in the affected side by the strength in the contralateral side. | 1 year | |
Secondary | Quality of life | Patients will complete the validated questionnaire 'EQ-5D', which covers 5 domains (mobility, personal care, daily activities, pain and mood), as well as a 100 point thermometer on general health. | 1 year | |
Secondary | Post-operative status of rotator cuff | Based on MRI imaging at 1 year after surgery, the rotator cuff is classified as fully healed, partially healed or recurrent rupture. | 1 year | |
Secondary | Duration of surgery | The duration of surgery will be calculated based on the start and end times of each surgery. | 1 year | |
Secondary | Complications | All complications and serious adverse events in the study population are recorded. | 1 year |
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