SLAP LesionsNCT00586742
SLAP Lesions; a Comparison of Conservative and Operative Treatment. A Prospective, Randomized Study
A study testing labral repair, biceps tenodesis and diagnostic arthroscopy in people with SLAP Lesions, run by Lovisenberg Diakonale Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- SLAP Lesions
- What is being tested?
- labral repair, biceps tenodesis and diagnostic arthroscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 118 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2008to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical history and signs of superior labral lesion
- MRI study revealing an isolated superior labral lesion
Who cannot join
- Other accompanying shoulderpathologies(such as cufflesions, instability, ac-joint pain, arthritis)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- SLAP Lesions
- Being tested
- labral repair, biceps tenodesis, diagnostic arthroscopy
- Keywords
- SLAP lesions, labral repair, bicepstenodesis, conservative treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
labral repairProcedure or surgery
Also called lupine anchor
labral repair with suture anchors
biceps tenodesisProcedure or surgery
Also called suture anchor
biceps tenodesis with suture anchor
diagnostic arthroscopyProcedure or surgery
diagnostic arthroscopy
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Labral repair with suture anchors Receives: Procedure: labral repair |
| 2 | Active comparator | Biceps tenodesis with suture anchor Receives: Procedure: biceps tenodesis |
| 3 | Sham comparator | only a diagnostic arthroscopy performed Receives: Procedure: diagnostic arthroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
WOSI score Constant score EQ-5D Rowe score Patient Satisfaction
Measured: 6 and 24 months
Secondary outcomes (1)
Sick leave Time back to sports at preoperative level
Measured: 6 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2008 (estimated)
- Study startJan 2008
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SLAP LesionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lovisenberg Diakonale Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- cecilie p schrøder, MD, Principal investigator, Lovisenberg Diakonale HospitalJens i Brox, MD, PhD, Study chair, University of Oslo, Rikshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00586742
- Sponsor's protocol ID
- IRB00001870
- Status last verified
- May 2016
- First submitted
- 21 Dec 2007
- Last updated
- 25 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 32241790Schroder 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.
PubMed 28495804Skare 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.
PubMed 20929552
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SLAP Lesions; a Comparison of Conservative and Operative Treatment. A Prospective, Randomized Study
- ClinicalTrials.gov ID
- NCT00586742
- Acronym / sponsor ID
- IRB00001870
- Conditions
- SLAP Lesions
- Keywords
- SLAP lesions, labral repair, bicepstenodesis, conservative treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Lovisenberg Diakonale HospitalUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 4 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: labral repairLabral repair with suture anchors |
| 2 | Active comparator | Procedure: biceps tenodesisBiceps tenodesis with suture anchor |
| 3 | Sham comparator | Procedure: diagnostic arthroscopyonly a diagnostic arthroscopy performed |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical history and signs of superior labral lesion
- MRI study revealing an isolated superior labral lesion
Key exclusion criteria (1 listed)
- Other accompanying shoulderpathologies(such as cufflesions, instability, ac-joint pain, arthritis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| labral repairAlso: lupine anchorlabral repair with suture anchors | Procedure or surgery | 1 |
| biceps tenodesisAlso: suture anchorbiceps tenodesis with suture anchor | Procedure or surgery | 2 |
| diagnostic arthroscopydiagnostic arthroscopy | Procedure or surgery | 3 |
Primary outcome
WOSI score Constant score EQ-5D Rowe score Patient Satisfaction
Time frame: 6 and 24 months
1 secondary outcome
Sick leave Time back to sports at preoperative level
Time frame: 6 and 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2016.
- Derived from this study: PubMed 32241790Brox 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.
- Derived from this study: PubMed 28495804Schroder 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.
- Derived from this study: PubMed 20929552Skare 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.
Related trials for SLAP Lesions
Recruiting
Biceps Tenodesis With 360 Suture Anchor Versus Self Locking Tenodesis In the Absence of Rotator Cuff Tears
SLAP Lesion
Not yet recruitingObservational study
Reliability and Accuracy of a New Clinical Test for Biceps Lesions
Lesion of Long Head of Biceps, SLAP Lesion
Not yet recruiting
Biceps Tenodesis Alone Versus Biceps Tenodesis and Labrum Repair in Superior Labrum Anteroposterior ( SLAP) From Type II to Type IV
SLAP Lesion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
cecilie p schrøder, MD principal investigator
Lovisenberg Diakonale Hospital
Jens i Brox, MD, PhD study chair
University of Oslo, Rikshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing labral repair, biceps tenodesis and diagnostic arthroscopy in people with SLAP Lesions, run by Lovisenberg Diakonale Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WOSI score Constant score EQ-5D Rowe score Patient Satisfaction (time frame: 6 and 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00586742, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2016.