SLAP Lesions; a Comparison of Conservative and Operative Treatment. A Prospective, Randomized Study

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Lovisenberg Diakonale Hospital

ClinicalTrials.gov Identifier:

NCT00586742

First received: December 21, 2007

Last updated: January 19, 2015

Last verified: January 2015

History of Changes

Purpose

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.

Condition	Intervention
SLAP Lesions	Procedure: labral repair Procedure: biceps tenodesis Procedure: diagnostic arthroscopy


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Treatment
Official Title:	SLAP Lesions; a Comparison of Conservative and Operative Treatment. A Prospective, Randomized Study

Further study details as provided by Lovisenberg Diakonale Hospital:

Primary Outcome Measures:

WOSI score Constant score EQ-5D Rowe score Patient Satisfaction [ Time Frame: 6 and 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Sick leave Time back to sports at preoperative level [ Time Frame: 6 and 24 months ] [ Designated as safety issue: No ]


Estimated Enrollment:	120
Study Start Date:	January 2008
Estimated Study Completion Date:	January 2016
Estimated Primary Completion Date:	January 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Labral repair with suture anchors	Procedure: labral repair labral repair with suture anchors Other Name: lupine anchor
Active Comparator: 2 Biceps tenodesis with suture anchor	Procedure: biceps tenodesis biceps tenodesis with suture anchor Other Name: suture anchor
Sham Comparator: 3 only a diagnostic arthroscopy performed	Procedure: diagnostic arthroscopy diagnostic arthroscopy Other Name: diagnostic arthroscopy

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


Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00586742

Locations


Norway
Lovisenberg Diakonale Hospital
Oslo, Norway, 0789

Sponsors and Collaborators

Lovisenberg Diakonale Hospital

Investigators


Principal Investigator:	cecilie p schrøder, MD	Lovisenberg Diakonale Hospital
Study Chair:	Jens i Brox, MD, PhD	University of Oslo, Rikshospitalet

More Information

No publications provided


Responsible Party:	Lovisenberg Diakonale Hospital
ClinicalTrials.gov Identifier:	NCT00586742 History of Changes
Other Study ID Numbers:	IRB00001870
Study First Received:	December 21, 2007
Last Updated:	January 19, 2015
Health Authority:	Norway:National Committee for Medical and Health Research Ethics Norway: Norwegian Social Science Data Services

Keywords provided by Lovisenberg Diakonale Hospital:


SLAP lesions labral repair bicepstenodesis conservative treatment

ClinicalTrials.gov processed this record on February 25, 2015

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