Tenotomy or Tenodesis of Long Head Biceps in Arthroscopic Rotator Cuff Repair

Rotator Cuff Syndrome Clinical Trial

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Official title:

Long Head Biceps Tenodesis or Tenotomy in Arthroscopic Rotator Cuff Repair: An International Multicenter Prospective Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02655848
• Other study ID #: WO 10.087
• Status: Completed
• Phase: N/A
• Start date: July 2012
• Est. completion date: September 2019

Study information

• Verified date: September 2019
• Source: Onze Lieve Vrouwe Gasthuis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Patients older than 50 years with a supraspinatus and/or infraspinatus tendon rupture sized smaller than 3cm, who are encountered with LHB pathology, will be randomized to either LHB tenotomy or LHB tenodesis. Clinical and self-reported data will be collected pre-operatively, and 6 weeks, 3 months, and 1 year after surgery.

Primary outcome is overall shoulder function evaluated with the Constant score. As additional measures of shoulder function, the Dutch Oxford Shoulder Test and the Disabilities of the Arm Shoulder and Hand questionnaire will be assessed. Other evaluations include cosmetic appearance evaluated by the ''Popeye'' deformity, arm cramping pain, elbow flexion strength, MRI evaluation, quality of life, and cost of surgery. To detect non-inferiority with a one-sided, two-sample t-test with a 80% power and a significance level (alpha) of 0.025, the required sample size is 98 patients.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Rotator Cuff Syndrome

Intervention

Procedure:
• Arthroscopic rotator cuff repair
Arthroscopic rotator cuff repair using suture anchors
• LHB Tenodesis
Arthroscopic tenotomy and subsequent fixation of long head biceps proximal in the biceps groove
• LHB Tenotomy
Arthroscopic tenotomy of long head biceps

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
Onze Lieve Vrouwe Gasthuis	Nederlandse Vereniging voor Arthroscopie, Smith & Nephew, Inc.

Country where clinical trial is conducted

Netherlands, 

References & Publications (3)

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

Outcome

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