Clinical trial NCT00586742: SLAP Lesions; a Comparison of Conservative and Operative Treatment. A Prospective, Randomized Study
Official title: SLAP Lesions; a Comparison of Conservative and Operative Treatment. A Prospective, Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: SLAP Lesions
Keywords: SLAP lesions
labral repair
bicepstenodesis
conservative treatment
Lead sponsor: Lovisenberg Diakonale Hospital
Sponsor class: OTHER
First posted: 2008-01-04
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate whether there is a difference between conservative and operative treatment of Superior Labral Lesions(SLAP)of the shoulder.

Detailed description: Treatment of superior labral lesions is controversial. Some authors advocate labral repair, some advocate biceps tenodesis,and others again questions whether these lesions should be repaired at all. There are no randomized studies comparing operative treatment and conservative treatment(i.e. physical rehabilitation), and likewise no randomized studies comparing labral repair and biceps tenodesis.

In this study;all patients who have a patient history, clinical signs of a SLAP lesion,a MRI study revealing an isolated superior labral lesion and have agreed to participate in the study, will have a diagnostic arthroscopy performed.

If a SLAP lesion is diagnosed, the patients are randomized to three different groups:1) SLAP repair with suture anchors 2) Biceps tenodesis 3) Physical therapy

Eligibility criteria: Inclusion Criteria:

* Clinical history and signs of superior labral lesion
* MRI study revealing an isolated superior labral lesion

Exclusion Criteria:earlier shoulder procedures,

* Other accompanying shoulderpathologies(such as cufflesions, instability, ac-joint pain, arthritis)

Primary outcomes:
measure: WOSI score Constant score EQ-5D Rowe score Patient Satisfaction
timeFrame: 6 and 24 months
Secondary outcomes:
measure: Sick leave Time back to sports at preoperative level
timeFrame: 6 and 24 months
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Lovisenberg Diakonale Hospital
Study officials:
affiliation: Lovisenberg Diakonale Hospital
name: cecilie p schrøder, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Oslo, Rikshospitalet
name: Jens i Brox, MD, PhD
role: STUDY_CHAIR
References:
citation: Brox JI, Skare O, Mowinckel P, Brox JS, Reikeras O, Schroder CP. Sick leave and return to work after surgery for type II SLAP lesions of the shoulder: a secondary analysis of a randomised sham-controlled study. BMJ Open. 2020 Apr 1;10(4):e035259. doi: 10.1136/bmjopen-2019-035259.
citation: Schroder CP, Skare O, Reikeras O, Mowinckel P, Brox JI. Sham surgery versus labral repair or biceps tenodesis for type II SLAP lesions of the shoulder: a three-armed randomised clinical trial. Br J Sports Med. 2017 Dec;51(24):1759-1766. doi: 10.1136/bjsports-2016-097098. Epub 2017 May 11.
citation: Skare O, Schroder CP, Reikeras O, Mowinckel P, Brox JI. Efficacy of labral repair, biceps tenodesis, and diagnostic arthroscopy for SLAP lesions of the shoulder: a randomised controlled trial. BMC Musculoskelet Disord. 2010 Oct 7;11:228. doi: 10.1186/1471-2474-11-228.