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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00586742
Enrollment
118
Registered
2008-01-04
Start date
2008-01-31
Completion date
2016-04-30
Last updated
2016-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

SLAP Lesions

Keywords

SLAP lesions, labral repair, bicepstenodesis, conservative 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

Interventions

PROCEDURElabral repair

labral repair with suture anchors

biceps tenodesis with suture anchor

diagnostic arthroscopy

Sponsors

Lovisenberg Diakonale Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
WOSI score Constant score EQ-5D Rowe score Patient Satisfaction6 and 24 months

Secondary

MeasureTime frame
Sick leave Time back to sports at preoperative level6 and 24 months

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 30, 2026