NCT00586742

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
118

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

December 21, 2007

Completed
11 days until next milestone

Study Start

First participant enrolled

January 1, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 4, 2008

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

May 25, 2016

Status Verified

May 1, 2016

Enrollment Period

8.3 years

First QC Date

December 21, 2007

Last Update Submit

May 24, 2016

Conditions

SLAP Lesions

Keywords

SLAP lesionslabral repairbicepstenodesisconservative treatment

Outcome Measures

Primary Outcomes (1)

  • WOSI score Constant score EQ-5D Rowe score Patient Satisfaction

    6 and 24 months

Secondary Outcomes (1)

  • Sick leave Time back to sports at preoperative level

    6 and 24 months

Study Arms (3)

1

ACTIVE COMPARATOR

Labral repair with suture anchors

Procedure: labral repair

2

ACTIVE COMPARATOR

Biceps tenodesis with suture anchor

Procedure: biceps tenodesis

3

SHAM COMPARATOR

only a diagnostic arthroscopy performed

Procedure: diagnostic arthroscopy

Interventions

labral repairPROCEDURE

labral repair with suture anchors

Also known as: lupine anchor
1
biceps tenodesisPROCEDURE

biceps tenodesis with suture anchor

Also known as: suture anchor
2
diagnostic arthroscopyPROCEDURE

diagnostic arthroscopy

3

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lovisenberg Diakonale Hospital

Oslo, Oslo County, 0789, Norway

Location

Related Publications (3)

  • 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.

    PMID: 32241790DERIVED

  • 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.

    PMID: 28495804DERIVED

  • 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.

    PMID: 20929552DERIVED

MeSH Terms

Interventions

Suture Anchors

Intervention Hierarchy (Ancestors)

Internal FixatorsProstheses and ImplantsEquipment and SuppliesOrthopedic Fixation DevicesOrthopedic EquipmentSurgical EquipmentSurgical Fixation Devices

Study Officials

  • cecilie p schrøder, MD

    Lovisenberg Diakonale Hospital

    PRINCIPAL INVESTIGATOR

  • Jens i Brox, MD, PhD

    University of Oslo, Rikshospitalet

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2007

First Posted

January 4, 2008

Study Start

January 1, 2008

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

May 25, 2016

Record last verified: 2016-05

Locations

NO(1)