Acetabular Labrum TearALERTNCT03257709
The Arthroscopic Labral Excision or Repair Trial (ALERT)
A study testing Arthroscopic acetabular labral repair and Arthroscopic acetabular labral resection in people with Acetabular Labrum Tear, run by University of Oxford at 1 site in United Kingdom.
Trial summary
This study compares two established surgical treatments for acetabular labral tears. Patients will be prospectively recruited and randomised to either labral repair or debridement. All patients will be followed for 2 years after intervention with a primary outcome assessment at 6 months. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acetabular Labrum Tear
- What is being tested?
- Arthroscopic acetabular labral repair and Arthroscopic acetabular labral resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2016to Dec 2019
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to give informed consent for participation in the study.
- Male or Female, aged between 18 and 75 years.
- Symptomatic labral tear with evidence of labral tear on MRI.
- No radiographic evidence of OA (Kellgren-Lawrence Grade < 2)
Who cannot join
- Previous ipsilateral hip surgery
- Irreparable labral tear
- Previous fracture of femoral neck or acetabulum
- Female patient who is pregnant
- Established osteoarthritis (Kellgren-Lawrence ≥ 2)
- Hip dysplasia
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Nuffield Orthopaedic Centre, Oxford University Hospitals Trust
Oxford, Oxfordshire, OX3 7LD
Joanna Burchall, 01865737694, joanna.burchall@ndorms.px.ac.uk
John Broomfield, 01865737694, john.broomfield@ndorms.ox.ac.uk
About this study
Official title: The Arthroscopic Labral Excision or Repair Trial (ALERT) - A Randomised Controlled Trial to Determine the Effectiveness of Arthroscopic Hip Labral Surgery
This study compares two established surgical treatments for acetabular labral tears. Patients will be prospectively recruited and randomised to either labral repair or debridement. All patients will be followed for 2 years after intervention with a primary outcome assessment at 6 months.
Read the detailed description
STUDY DESIGN
Study design This will be a two-arm randomised controlled parallel group superiority study and will take place in a hospital setting. Stratification will be performed for sex and age by means of a minimisation technique during randomisation for each subject entering the trial.
Study population:
Adults between 18 and 75 years of age diagnosed with symptomatic acetabular labral tears demonstrated on MRI arthrogram but without radiographic evidence of OA ie: Kellgren \& Lawrence grade less than 2 randomly selected from the Nuffield Orthopaedic Centre outpatient clinics.
Arm 1 Arthroscopic acetabular labral repair.
Arm 2 Arthroscopic acetabular labral resection
48 patients per arm (total 96 patients) will be selected from outpatient clinics and the operative waiting list (pre-operative assessment clinics) at the Nuffield Orthopaedic Centre, Oxford. The surgeries will be conducted using routine instrumentation in use at the centre.
STUDY PROCEDURES
Recruitment
All patients will undergo surgery in accordance with established practice regardless of their treatment allocation. Arthroscopy will be performed using standard anterior and lateral portals for insertion of instruments. All patients will undergo arthroscopic evaluation of the entire joint. Subsequent procedures will vary according to treatment allocation:
- Arm 1 - Labral Repair - acetabular labral tear will be identified and reattached using suture anchors until a stable repair is achieved. If evidence of FAI is present ie: a cam or pincer lesion is identified then this will be treated with osteochondroplasty (cam) or acetabular rim recession (pincer).
- Arm 2 - Labral Resection - the acetabular labral tear will be identified and its' limits defined. The torn portion of labrum will be resected to a stable edge. As with arm 1 there will be treatment of FAI if identified.
- Conditions
- Acetabular Labrum Tear
- Being tested
- Arthroscopic acetabular labral repair, Arthroscopic acetabular labral resection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthroscopic acetabular labral repairProcedure or surgery
Also called Labral Repair, Labral Reconstruction
Acetabular labral tear will be identified and reattached using suture anchors until a stable repair is achieved. If evidence of FAI is present ie: a cam or pincer lesion is identified then this will be treated with osteochondroplasty (cam) or acetabular rim recession (pincer).
Arthroscopic acetabular labral resectionProcedure or surgery
Also called Labral Resection, Labral Debridement
The acetabular labral tear will be identified and its' limits defined. The torn portion of labrum will be resected to a stable edge. As with arm 1 there will be treatment of FAI if identified.
| Study group | Role | What they receive |
|---|---|---|
| Arthroscopic acetabular labral repair | Active comparator | Acetabular labral tear will be identified and reattached using suture anchors until a stable repair is achieved. If evidence of FAI is present ie: a cam or pincer lesion is identified then this will be treated with osteochondroplasty (cam) or acetabular rim recession (pincer). Receives: Procedure: Arthroscopic acetabular labral repair |
| Arthroscopic acetabular labral resection | Active comparator | The acetabular labral tear will be identified and its' limits defined. The torn portion of labrum will be resected to a stable edge. As with arm 1 there will be treatment of FAI if identified. Receives: Procedure: Arthroscopic acetabular labral resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hip Outcome Score
Change in Hip Outcome Score (Activities of Daily Living Subscale) at 6 months post intervention from baseline.
Measured: 6 Months Post Intervention
Secondary outcomes (8)
Hip Outcome Scores (HOS)
Hip Outcome Score at 12, 18 and 24 months post-operatively.
Measured: 12, 18 & 24 months post intervention
Physiologic MRI
T2 relaxation time
Measured: 6 Months Post Intervention
X Ray
Joint space width
Measured: 6 Months Post Intervention
X Ray
Kellgren-Lawrence score
Measured: 6 Months Post Intervention
Biomarkers of Osteo Arthritis (OA)
Biomarkers of OA from synovial fluid and serum.
Measured: At surgery and 6, 12 & 24 months post intervention.
Clinical Assessment of Function
Clinical assessment of range of motion and impingement tests.
Measured: 6, 12 & 24 months post intervention.
Health Economics
Assessment of economic burden associated with disease using EQ5D score
Measured: 6, 12, 18 & 24 months post intervention
Physiologic MRI
T1 Rho
Measured: 6 Months Post Intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2017
- Study startDec 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acetabular Labrum TearStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Arthritis Research UK, The Royal College of Surgeons of England
- Responsible party
- Sponsor
- Investigators
- Sion Glyn-Jones, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03257709
- Sponsor's protocol ID
- IRAS 184490
- Acronym
- ALERT
- Status last verified
- Aug 2017
- First submitted
- 4 Jan 2017
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Arthroscopic Labral Excision or Repair Trial (ALERT) - A Randomised Controlled Trial to Determine the Effectiveness of Arthroscopic Hip Labral Surgery
- ClinicalTrials.gov ID
- NCT03257709
- Acronym / sponsor ID
- ALERT / IRAS 184490
- Conditions
- Acetabular Labrum Tear
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Arthritis Research UK, The Royal College of Surgeons of England
- Study start
- Dec 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 22 Aug 2017 (actual)
- 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.
This study compares two established surgical treatments for acetabular labral tears. Patients will be prospectively recruited and randomised to either labral repair or debridement. All patients will be followed for 2 years after intervention with a primary outcome assessment at 6 months.
Detailed description
STUDY DESIGN
Study design This will be a two-arm randomised controlled parallel group superiority study and will take place in a hospital setting. Stratification will be performed for sex and age by means of a minimisation technique during randomisation for each subject entering the trial.
Study population:
Adults between 18 and 75 years of age diagnosed with symptomatic acetabular labral tears demonstrated on MRI arthrogram but without radiographic evidence of OA ie: Kellgren \& Lawrence grade less than 2 randomly selected from the Nuffield Orthopaedic Centre outpatient clinics.
Arm 1 Arthroscopic acetabular labral repair.
Arm 2 Arthroscopic acetabular labral resection
48 patients per arm (total 96 patients) will be selected from outpatient clinics and the operative waiting list (pre-operative assessment clinics) at the Nuffield Orthopaedic Centre, Oxford. The surgeries will be conducted using routine instrumentation in use at the centre.
STUDY PROCEDURES
Recruitment
All patients will undergo surgery in accordance with established practice regardless of their treatment allocation. Arthroscopy will be performed using standard anterior and lateral portals for insertion of instruments. All patients will undergo arthroscopic evaluation of the entire joint. Subsequent procedures will vary according to treatment allocation:
- Arm 1 - Labral Repair - acetabular labral tear will be identified and reattached using suture anchors until a stable repair is achieved. If evidence of FAI is present ie: a cam or pincer lesion is identified then this will be treated with osteochondroplasty (cam) or acetabular rim recession (pincer).
- Arm 2 - Labral Resection - the acetabular labral tear will be identified and its' limits defined. The torn portion of labrum will be resected to a stable edge. As with arm 1 there will be treatment of FAI if identified.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arthroscopic acetabular labral repair | Active comparator | Procedure: Arthroscopic acetabular labral repairAcetabular labral tear will be identified and reattached using suture anchors until a stable repair is achieved. If evidence of FAI is present ie: a cam or pincer lesion is identified then this will be treated with osteochondroplasty (cam) or acetabular rim recession (pincer). |
| Arthroscopic acetabular labral resection | Active comparator | Procedure: Arthroscopic acetabular labral resectionThe acetabular labral tear will be identified and its' limits defined. The torn portion of labrum will be resected to a stable edge. As with arm 1 there will be treatment of FAI if identified. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Willing and able to give informed consent for participation in the study.
- Male or Female, aged between 18 and 75 years.
- Symptomatic labral tear with evidence of labral tear on MRI.
- No radiographic evidence of OA (Kellgren-Lawrence Grade < 2)
Key exclusion criteria (6 listed)
- Previous ipsilateral hip surgery
- Irreparable labral tear
- Previous fracture of femoral neck or acetabulum
- Female patient who is pregnant
- Established osteoarthritis (Kellgren-Lawrence ≥ 2)
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 |
|---|---|---|
| Arthroscopic acetabular labral repairAlso: Labral Repair, Labral ReconstructionAcetabular labral tear will be identified and reattached using suture anchors until a stable repair is achieved. If evidence of FAI is present ie: a cam or pincer lesion is identified then this will be treated with osteochondroplasty (cam) or acetabular rim recession (pincer). | Procedure or surgery | Arthroscopic acetabular labral repair |
| Arthroscopic acetabular labral resectionAlso: Labral Resection, Labral DebridementThe acetabular labral tear will be identified and its' limits defined. The torn portion of labrum will be resected to a stable edge. As with arm 1 there will be treatment of FAI if identified. | Procedure or surgery | Arthroscopic acetabular labral resection |
Primary outcome
Hip Outcome Score
Time frame: 6 Months Post Intervention
Change in Hip Outcome Score (Activities of Daily Living Subscale) at 6 months post intervention from baseline.
8 secondary outcomes
Hip Outcome Scores (HOS)
Time frame: 12, 18 & 24 months post intervention
Physiologic MRI
Time frame: 6 Months Post Intervention
X Ray
Time frame: 6 Months Post Intervention
X Ray
Time frame: 6 Months Post Intervention
Biomarkers of Osteo Arthritis (OA)
Time frame: At surgery and 6, 12 & 24 months post intervention.
Clinical Assessment of Function
Time frame: 6, 12 & 24 months post intervention.
Health Economics
Time frame: 6, 12, 18 & 24 months post intervention
Physiologic MRI
Time frame: 6 Months Post Intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2017.
- Individual participant dataSharing planned: No
Related trials for Acetabular Labrum Tear
Active, not recruiting
Arthroscopic Labral Repair Versus Physical Therapy for Tears of the Acetabular Labrum
Acetabular Labrum Tear, Femoro Acetabular Impingement
RecruitingObservational study
Use of BMAC With Hip Arthroscopy Treatment of FAI and Labral Tear
Acetabular Labrum Tear, Femoro Acetabular Impingement
RecruitingPhase 3
Effect of PRP, PPP, & BMAC on Functional Outcomes Following Hip Arthroscopy for Acetabular Labral Pathologies
Acetabular Labrum Tear, Femoro Acetabular Impingement
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.
Sion Glyn-Jones principal investigator
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arthroscopic acetabular labral repair and Arthroscopic acetabular labral resection in people with Acetabular Labrum Tear, run by University of Oxford at 1 site in United Kingdom.
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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 22 Aug 2017. 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 United Kingdom. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joanna S Burchall (01865737694, joanna.burchall@ndorms.ox.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hip Outcome Score (time frame: 6 Months Post Intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Aug 2017.