NCT02655848

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

December 29, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 14, 2016

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

October 1, 2019

Status Verified

September 1, 2019

Enrollment Period

7.2 years

First QC Date

December 29, 2015

Last Update Submit

September 27, 2019

Conditions

Rotator Cuff Syndrome

Keywords

PopeyeLong Head Biceps TendonArthroscopyFunctional result

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Popeye phenomenon

    1 year

  • Cosmetic appearance

    1 year

  • MRI-based location of the biceps tendon

    1 year

  • Self-reported shoulder function

    1 year

  • Pain

    1 year

  • +5 more secondary outcomes

Study Arms (2)

@ Cuff repair with LHB tenodesis

ACTIVE COMPARATOR

In case of pathologic changes of the long Head Biceps tendon, a tenodesis is performed in adjunct to performing an arthroscopic rotator cuff repair.

Procedure: Arthroscopic rotator cuff repairProcedure: LHB Tenodesis

@ cuff repair with LHB tenotomy

ACTIVE COMPARATOR

In case of pathologic changes of the long Head Biceps tendon, a tenotomy is performed in adjunct to performing an arthroscopic rotator cuff repair.

Procedure: Arthroscopic rotator cuff repairProcedure: LHB Tenotomy

Interventions

Arthroscopic rotator cuff repairPROCEDURE

Arthroscopic rotator cuff repair using suture anchors

@ Cuff repair with LHB tenodesis@ cuff repair with LHB tenotomy
LHB TenodesisPROCEDURE

Arthroscopic tenotomy and subsequent fixation of long head biceps proximal in the biceps groove

@ Cuff repair with LHB tenodesis
LHB TenotomyPROCEDURE

Arthroscopic tenotomy of long head biceps

@ cuff repair with LHB tenotomy

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Slootervaart ziekenhuis

Amsterdam, 1066EC, Netherlands

Location

Kliniek De Lairesse

Amsterdam, 1075BG, Netherlands

Location

OLVG

Amsterdam, 1090HM, Netherlands

Location

Gelre ziekenhuis

Apeldoorn, 7334DZ, Netherlands

Location

Amphia ziekenhuis

Breda, 4819JV, Netherlands

Location

Groene Hart Ziekenhuis

Gouda, 2803HH, Netherlands

Location

Tergooi Ziekenhuizen

Hilversum, Netherlands

Location

Spaarne Ziekenhuis

Hoofddorp, Netherlands

Location

St Antonius

Nieuwegein, 3430EM, Netherlands

Location

Canisius Wilehelmina Zkh

Nijmegen, Netherlands

Location

Related Publications (4)

  • 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. doi: 10.1007/s00167-015-3640-6. Epub 2015 May 15.

    PMID: 25975753BACKGROUND

  • 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.

    PMID: 23828089BACKGROUND

  • 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.

    PMID: 23088416BACKGROUND

  • van Deurzen DF, Scholtes VA, Willigenburg NW, Gurnani N, Verweij LP, van den Bekerom MP; BITE collaboration group. Long head BIceps TEnodesis or tenotomy in arthroscopic rotator cuff repair: BITE study protocol. BMC Musculoskelet Disord. 2016 Aug 30;17(1):375. doi: 10.1186/s12891-016-1230-5.

    PMID: 27577549DERIVED

Study Officials

  • Derek van Deurzen, MD

    OLVG

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Orthopedic Surgeon

Study Record Dates

First Submitted

December 29, 2015

First Posted

January 14, 2016

Study Start

July 1, 2012

Primary Completion

September 1, 2019

Study Completion

September 1, 2019

Last Updated

October 1, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

NL(10)