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

NCT ID: NCT00586742

Last Updated: 2016-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2016-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

SLAP Lesions

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Labral repair with suture anchors

Group Type ACTIVE_COMPARATOR

labral repair

Intervention Type PROCEDURE

labral repair with suture anchors

2

Biceps tenodesis with suture anchor

Group Type ACTIVE_COMPARATOR

biceps tenodesis

Intervention Type PROCEDURE

biceps tenodesis with suture anchor

3

only a diagnostic arthroscopy performed

Group Type SHAM_COMPARATOR

diagnostic arthroscopy

Intervention Type PROCEDURE

diagnostic arthroscopy

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

labral repair

labral repair with suture anchors

Intervention Type PROCEDURE

biceps tenodesis

biceps tenodesis with suture anchor

Intervention Type PROCEDURE

diagnostic arthroscopy

diagnostic arthroscopy

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

lupine anchor suture anchor

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Lovisenberg Diakonale Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

cecilie p schrøder, MD

Role: PRINCIPAL_INVESTIGATOR

Lovisenberg Diakonale Hospital

Jens i Brox, MD, PhD

Role: STUDY_CHAIR

University of Oslo, Rikshospitalet

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Lovisenberg Diakonale Hospital

Oslo, Oslo County, Norway

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Norway

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 32241790 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28495804 (View on PubMed)

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.

Reference Type DERIVED
PMID: 20929552 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IRB00001870

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Biceps Tenodesis Versus Tenotomy
NCT01747902 COMPLETED NA
Results of Rotator Cuff Repair
NCT01549912 COMPLETED