Hip InjuriesNCT06288867
A 12 Months Prospective Study Comparing Functional Outcome Scores in Hip Arthroscopic Labral Repair Versus Debridement
A study testing Arthroscopic Labral Repair and Arthroscopic Labral Debridement in people with Hip Injuries and Acetabular Labral Tear, run by Ain Shams University at 1 site in Egypt.
Trial summary
This study aims to address hip labral tears and compare arthroscopic labral repair versus debridement in non-athletic population aged 20 to 50 years old, including both sexes. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Hip Injuries, Acetabular Labral Tear, Femoro Acetabular Impingement
- What is being tested?
- Arthroscopic Labral Repair and Arthroscopic Labral Debridement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to 1 Oct 2025
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Sex: both sexes.
- Age: 20 years - 50 years, non-athletes.
- Femoroacetabular impingement (FAI) including all types (cam, pincer, and combined).
Who cannot join
- Previous hip surgery.
- Hip joint dysplasia, defined by both center edge (CE) angles <25 degrees and Acetabular Index angle >10 degrees.
- Osteoarthritis grade >2 according to Tönnis classification.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Arthroscopic Labral Repair Versus Debridement In Hip Labral Tears: A Prospective Comparative Study
This study aims to address hip labral tears and compare arthroscopic labral repair versus debridement in non-athletic population aged 20 to 50 years old, including both sexes.
Read the detailed description
Hip arthroscopy will be performed with the patient under general anesthesia. The patient will be placed in supine position, and traction and joint access will be controlled by fluoroscopy. An anterolateral portal and an inferior mid-anterior portal will be used. Any labral, chondral, and/or bony pathology (cam or pincer) will be treated. Labral tears may be debrided or repaired. Labral repairs will be secured with suture anchors.
Patient's functions will be evaluated preoperatively and postoperatively at 1, 3 and 6 months and 1 year and at the last follow-up using the Harris Hip Score (HHS), visual analog score (VAS), Hip Outcome Score Activities-Daily Living Subscale (HOS-ADL), and Sport-Specific Subscale (HOS-SSS).
- Being tested
- Arthroscopic Labral Repair, Arthroscopic Labral Debridement
- Keywords
- Hip Arthroscopy, Labral Repair, Labral Debridement, Acetabular Labral Tear
- Medical subject headings
- Hip Injuries, Femoracetabular Impingement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthroscopic Labral RepairProcedure or surgery
Patients with Hip Labral tears will be treated with labral repair
Arthroscopic Labral DebridementProcedure or surgery
Patients with Hip Labral tears will be treated with labral debridement
| Study group | Role | What they receive |
|---|---|---|
| Labral Repair | Active comparator | Labral tears will be repaired with suture anchors. Receives: Procedure: Arthroscopic Labral Repair |
| Labral Debridement | Active comparator | Labral Debridement will be done Receives: Procedure: Arthroscopic Labral Debridement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Hip Function, as measured by Hip Outcome Score (HOS)
The HOS is a patient-completed measure that consists of an "Activities of Daily Living" subscale (17 scored items) and a "Sports" subscale (9 scored items) in which the response options are presented as 5-point Likert scales (Scores 0-4). Scores for each subscale range from 0% (least function) to 100% (most function).The highest potential score is 68, a higher score represents a higher level of physical function for both the ADL and sports subscales
Measured: Baseline, 1 year
Change from baseline in Hip Function, as measured by Harris Hip Score (HHS)
<70 (poor result), 70-79 (fair result), 80-89 (good result) and >90 (excellent result)
Measured: Baseline, 1 year
Change from baseline in Pain, as measured by the Visual Analogue Scale (VAS)
Scores are measured on a 100 mm VAS. The VAS ranges from 0 to 100 with 0 indicating no pain, and higher scores indicating greater pain
Measured: Baseline, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study start1 Jan 2024
- Primary completion24 Apr 2025
- Study completion1 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip InjuriesStudies 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, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karim Atef Salem, Ain Shams University
- Investigators
- Karim A Salem, MD, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06288867
- Sponsor's protocol ID
- FMASU MD28/2024
- Status last verified
- Aug 2025
- First submitted
- 24 Feb 2024
- Last updated
- 9 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arthroscopic Labral Repair Versus Debridement In Hip Labral Tears: A Prospective Comparative Study
- ClinicalTrials.gov ID
- NCT06288867
- Acronym / sponsor ID
- FMASU MD28/2024
- Keywords
- Hip Arthroscopy, Labral Repair, Labral Debridement, Acetabular Labral Tear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 24 Apr 2025 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 1 Mar 2024 (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 aims to address hip labral tears and compare arthroscopic labral repair versus debridement in non-athletic population aged 20 to 50 years old, including both sexes.
Detailed description
Hip arthroscopy will be performed with the patient under general anesthesia. The patient will be placed in supine position, and traction and joint access will be controlled by fluoroscopy. An anterolateral portal and an inferior mid-anterior portal will be used. Any labral, chondral, and/or bony pathology (cam or pincer) will be treated. Labral tears may be debrided or repaired. Labral repairs will be secured with suture anchors.
Patient's functions will be evaluated preoperatively and postoperatively at 1, 3 and 6 months and 1 year and at the last follow-up using the Harris Hip Score (HHS), visual analog score (VAS), Hip Outcome Score Activities-Daily Living Subscale (HOS-ADL), and Sport-Specific Subscale (HOS-SSS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Labral Repair | Active comparator | Procedure: Arthroscopic Labral RepairLabral tears will be repaired with suture anchors. |
| Labral Debridement | Active comparator | Procedure: Arthroscopic Labral DebridementLabral Debridement will be done |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Sex: both sexes.
- Age: 20 years - 50 years, non-athletes.
- Femoroacetabular impingement (FAI) including all types (cam, pincer, and combined).
Key exclusion criteria (3 listed)
- Previous hip surgery.
- Hip joint dysplasia, defined by both center edge (CE) angles <25 degrees and Acetabular Index angle >10 degrees.
- Osteoarthritis grade >2 according to Tönnis classification.
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 Labral RepairPatients with Hip Labral tears will be treated with labral repair | Procedure or surgery | Labral Repair |
| Arthroscopic Labral DebridementPatients with Hip Labral tears will be treated with labral debridement | Procedure or surgery | Labral Debridement |
Primary outcome
Change from baseline in Hip Function, as measured by Hip Outcome Score (HOS)
Time frame: Baseline, 1 year
The HOS is a patient-completed measure that consists of an "Activities of Daily Living" subscale (17 scored items) and a "Sports" subscale (9 scored items) in which the response options are presented as 5-point Likert scales (Scores 0-4). Scores for each subscale range from 0% (least function) to 100% (most function).The highest potential score is 68, a higher score represents a higher level of physical function for both the ADL and sports subscales
Change from baseline in Hip Function, as measured by Harris Hip Score (HHS)
Time frame: Baseline, 1 year
<70 (poor result), 70-79 (fair result), 80-89 (good result) and >90 (excellent result)
Change from baseline in Pain, as measured by the Visual Analogue Scale (VAS)
Time frame: Baseline, 1 year
Scores are measured on a 100 mm VAS. The VAS ranges from 0 to 100 with 0 indicating no pain, and higher scores indicating greater pain
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 9 Jul 2026.
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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.
Karim A Salem, MD principal investigator
Ain Shams University
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 Labral Repair and Arthroscopic Labral Debridement in people with Hip Injuries and Acetabular Labral Tear, run by Ain Shams University at 1 site in Egypt.
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 3 inclusion and 3 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 9 Jul 2026. 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 Egypt. 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?
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?
Change from baseline in Hip Function, as measured by Hip Outcome Score (HOS) (time frame: Baseline, 1 year). The study lists 3 primary outcomes in all. 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 9 Jul 2026.