Femoro Acetabular ImpingementNCT06420180
Effect of Lower Limb Rotation on Clinical Outcomes After Arthroscopic Management in Patients With Symptomatic Femoroacetabular Impingement Syndrome
An observational study of Femoro Acetabular Impingement, run by Al-Azhar University.
Trial summary
To determine The prevalence of abnormalities of femoral and acetabular versions and tibial torsion in symptomatic (FAI) Syndrome. Analyse the subgroups of specific hip pathomorphologies associated with rotational abnormalities of lower limb (LL). Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Femoro Acetabular Impingement
- What is being tested?
- hip arthroscopy
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jul 2024to Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 45 years
- All sexes
- Adult
Study population: study will be conducted on patient aged between 18 to 45 years with radiographic imaging, history, and physical examination demonstrated evidence of FAI or labral tears; if they experienced moderate to severe pain that was unresponsive to at least 3 months of nonsurgical treatment, including physical therapy, nonsteroidal anti-inflammatory drugs, and activity modification
Who may be able to join
- • Accepted to participate in the study (signing informed consent).
- Skeletal maturity (Risser V score).
- If their radiographic imaging, history, and physical examination demonstrated evidence of FAI or labral tears; if they experienced moderate to severe pain that was unresponsive to at least 3 months of nonsurgical treatment, including physical therapy, nonsteroidal anti-inflammatory drugs, and activity modification
Who cannot join
- • Incomplete radiographic documentation.
- Previous surgery of the acetabulum, femur and/or tibia altering their version.
- Skeletally immature hips (stage IV according to Risser).
- Posttraumatic conditions.
- If they were previously diagnosed with an ipsilateral hip condition, such as avascular necrosis, legg-calvé-perthes disease, or slipped capital femoral epiphysis.
- If their tönnis grade of osteoarthritis is >1.
Show all 9Show fewer
- Hip dysplasia will be defined as a lateral centre-edge angle (LCEA) less than 22°.
- Patients with rheumatologic diseases.
- Patients at risk of radiation exposure, such as pregnant women and patients after neoplastic diseases.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
maysara mohammed contact
About this study
Official title: The Effect of Lower Limb Rotation on Clinical Outcomes After Arthroscopic Management in Patients With Symptomatic Femoroacetabular Impingement Syndrome
To determine
- The prevalence of abnormalities of femoral and acetabular versions and tibial torsion in symptomatic (FAI) Syndrome.
- Analyse the subgroups of specific hip pathomorphologies associated with rotational abnormalities of lower limb (LL).
- Which specific hip subtypes of (FAI) are associated with rotational abnormalities,
- Outcomes of arthroscopic treatment of (FAI) syndrome in patients with rotational abnormalities compared with a control group of patients with normal rotation.
Read the detailed description
Femoroacetabular impingement (FAI) is characterised by an abnormal contact between the acetabulum and the femur, limiting range of motion and leading to hip pain and disability.
(FAI) can be classified into three categories according to the specific pathomorphology involved. Cam type (FAI) represents asphericity of the femoral head due to abnormal morphology at the head neck junction. Pincer-type (FAI) on the other hand, occurs due to over-coverage of the femoral head by the acetabulum and premature contact between the acetabulum and femoral neck. Some patients may present with both of these abnormalities, known as mixed-typed (FAI).
There is an interest in the role of acetabular and femoral versions and tibial torsion in (FAI). Lerch et al. found that 68% of 538 hips presenting with (FAI) or dysplasia showed abnormal femoral and/or acetabular versions. A more recent study by Lerch et al. also found abnormal tibial torsion in 42% of patients with (FAI) and dysplasia. It has been further speculated that excessive femoral anteversion or femoral retroversion may also play a role in the pathogenesis and treatment of (FAI). Excessive femoral retroversion has been considered by some to be a relative contraindication to corrective (FAI) surgery, as it has been found to be a risk factor for poor outcomes after hip arthroscopy for (FAI). Similarly, increased femoral version is a risk factor for inferior clinical outcomes after hip arthroscopy. Abnormalities of femoral version and tibial torsion were associated with anterior knee pain, knee osteoarthritis, and patellar instability. But the influence of combined abnormalities of femoral version and tibial torsion (combined torsional malalignment) for patients with hip pain is unknown.
So, investigator hypothesized that patients with symptomatic (FAI) display significant rotation abnormalities of the acetabulum or femur and tibial and that the rotational abnormalities would portend an inferior prognosis when compared with a pair-matched control group of patients with normal range of lower limb rotation and patients with significant rotational abnormalities would have differing intraoperative hip pathology.
- Conditions
- Femoro Acetabular Impingement
- Being tested
- hip arthroscopy
- Medical subject headings
- Femoracetabular Impingement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hip arthroscopyProcedure or surgery
Also called MRI, CT
CT rotational profile Will be used for measurement of LL rotational abnormality.
MRI will be evaluated for the presence of labral tears, chondral lesions, ligamentum teres pathology, and other soft-tissue disorders.
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of lower limb rotation in FAI
determine the prevalence of abnormalities of femoral and acetabular versions and tibial torsion in symptomatic FAI Syndrome.
Measured: baseline
2 years outcome of arthroscopic treatment of 50 patients with FAI syndrome using modified Harris Hip Score (mHHS).
determine Outcomes of arthroscopic treatment of FAI syndrome in patients with rotational abnormalities compared with patients with normal rotation.
normal rotation according to preoperative CT rotational profile: Acetabular version angle between 10⁰ to 25⁰. Femoral version angle between 10⁰ to 25⁰. Tibial torsion angle between 25⁰ to 40⁰. clinical outcome of arthroscopic treatment of patients with FAI syndrome using modified Harris Hip Score (mHHS) will be done preoperatively and postoperatively at 1.5 months, 3 months, 6 months, 1 year, and 2 years.
The modified Harris hip score (mHHS) will be scored from 0 (worst functional outcome and maximum pain) to 100 points (best functional outcome and least pain)
Measured: 2 years
2 years outcome of arthroscopic treatment of 50 patients with FAI syndrome using Nonarthritic Hip Score (NAHS).
determine Outcomes of arthroscopic treatment of FAI syndrome in patients with rotational abnormalities compared with patients with normal rotation.
normal rotation according to preoperative CT rotational profile: Acetabular version angle between 10⁰ to 25⁰. Femoral version angle between 10⁰ to 25⁰. Tibial torsion angle between 25⁰ to 40⁰. clinical outcome of arthroscopic treatment of patients with FAI syndrome using Nonarthritic Hip Score (NAHS) will be done preoperatively and postoperatively at 1.5 months, 3 months, 6 months, 1 year, and 2 years.
This score is divided into four domains: pain, mechanical symptoms, physical function, and level of activity.
The maximum score is 100 indicating normal hip function.
Measured: 2 years
2 years outcome of arthroscopic treatment of 50 patients with FAI syndrome using Hip Outcome Score-Sports Specific Subscale (HOS-SSS)
determine Outcomes of arthroscopic treatment of FAI syndrome in patients with rotational abnormalities compared with patients with normal rotation.
normal rotation according to preoperative CT rotational profile: Acetabular version angle between 10⁰ to 25⁰. Femoral version angle between 10⁰ to 25⁰. Tibial torsion angle between 25⁰ to 40⁰. clinical outcome of arthroscopic treatment of patients with FAI syndrome using Hip Outcome Score-Sports Specific Subscale (HOS-SSS) will be done preoperatively and postoperatively at 1.5 months, 3 months, 6 months, 1 year, and 2 years.
The (HOS-SSS) is a patient-completed measure that consists of "(9 scored items) in which the response options are presented as 5-point Likert scales. Scores for each subscale range from 0% (least function) to 100% (most function).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study startJul 2024 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Femoro Acetabular ImpingementStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mahmoud ahmed awad elmetwally, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06420180
- Sponsor's protocol ID
- lower limb rotation on FAI
- Status last verified
- May 2024
- First submitted
- 11 May 2024
- Last updated
- 20 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Arshad Z, Maughan HD, Sunil Kumar KH, Pettit M, Arora A, Khanduja V. Over one third of patients with symptomatic femoroacetabular impingement display femoral or acetabular version abnormalities. Knee Surg Sports Traumatol Arthrosc. 2021 Sep;29(9):2825-2836. doi: 10.1007/s00167-021-06643-3. Epub 2021 Jul 6.
PubMed 34228156Lerch TD, Todorski IAS, Steppacher SD, Schmaranzer F, Werlen SF, Siebenrock KA, Tannast M. Prevalence of Femoral and Acetabular Version Abnormalities in Patients With Symptomatic Hip Disease: A Controlled Study of 538 Hips. Am J Sports Med. 2018 Jan;46(1):122-134. doi: 10.1177/0363546517726983. Epub 2017 Sep 22.
PubMed 28937786Lerch TD, Liechti EF, Todorski IAS, Schmaranzer F, Steppacher SD, Siebenrock KA, Tannast M, Klenke FM. Prevalence of combined abnormalities of tibial and femoral torsion in patients with symptomatic hip dysplasia and femoroacetabular impingement. Bone Joint J. 2020 Dec;102-B(12):1636-1645. doi: 10.1302/0301-620X.102B12.BJJ-2020-0460.R1.
PubMed 33249913Imhoff FB, Funke V, Muench LN, Sauter A, Englmaier M, Woertler K, Imhoff AB, Feucht MJ. The complexity of bony malalignment in patellofemoral disorders: femoral and tibial torsion, trochlear dysplasia, TT-TG distance, and frontal mechanical axis correlate with each other. Knee Surg Sports Traumatol Arthrosc. 2020 Mar;28(3):897-904. doi: 10.1007/s00167-019-05542-y. Epub 2019 May 24.
PubMed 31127313Grunwald L, Histing T, Springer F, Keller G. MRI-based torsion measurement of the lower limb is a reliable and valid alternative for CT measurement: a prospective study. Knee Surg Sports Traumatol Arthrosc. 2023 Nov;31(11):4903-4909. doi: 10.1007/s00167-023-07533-6. Epub 2023 Aug 17.
PubMed 37589766Suarez-Ahedo C, Gui C, Rabe SM, Chandrasekaran S, Lodhia P, Domb BG. Acetabular Chondral Lesions in Hip Arthroscopy: Relationships Between Grade, Topography, and Demographics. Am J Sports Med. 2017 Sep;45(11):2501-2506. doi: 10.1177/0363546517708192. Epub 2017 Jun 7.
PubMed 28590784
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Lower Limb Rotation on Clinical Outcomes After Arthroscopic Management in Patients With Symptomatic Femoroacetabular Impingement Syndrome
- ClinicalTrials.gov ID
- NCT06420180
- Acronym / sponsor ID
- lower limb rotation on FAI
- Conditions
- Femoro Acetabular Impingement
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- Jul 2024 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 17 May 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.
To determine
- The prevalence of abnormalities of femoral and acetabular versions and tibial torsion in symptomatic (FAI) Syndrome.
- Analyse the subgroups of specific hip pathomorphologies associated with rotational abnormalities of lower limb (LL).
- Which specific hip subtypes of (FAI) are associated with rotational abnormalities,
- Outcomes of arthroscopic treatment of (FAI) syndrome in patients with rotational abnormalities compared with a control group of patients with normal rotation.
Detailed description
Femoroacetabular impingement (FAI) is characterised by an abnormal contact between the acetabulum and the femur, limiting range of motion and leading to hip pain and disability.
(FAI) can be classified into three categories according to the specific pathomorphology involved. Cam type (FAI) represents asphericity of the femoral head due to abnormal morphology at the head neck junction. Pincer-type (FAI) on the other hand, occurs due to over-coverage of the femoral head by the acetabulum and premature contact between the acetabulum and femoral neck. Some patients may present with both of these abnormalities, known as mixed-typed (FAI).
There is an interest in the role of acetabular and femoral versions and tibial torsion in (FAI). Lerch et al. found that 68% of 538 hips presenting with (FAI) or dysplasia showed abnormal femoral and/or acetabular versions. A more recent study by Lerch et al. also found abnormal tibial torsion in 42% of patients with (FAI) and dysplasia. It has been further speculated that excessive femoral anteversion or femoral retroversion may also play a role in the pathogenesis and treatment of (FAI). Excessive femoral retroversion has been considered by some to be a relative contraindication to corrective (FAI) surgery, as it has been found to be a risk factor for poor outcomes after hip arthroscopy for (FAI). Similarly, increased femoral version is a risk factor for inferior clinical outcomes after hip arthroscopy. Abnormalities of femoral version and tibial torsion were associated with anterior knee pain, knee osteoarthritis, and patellar instability. But the influence of combined abnormalities of femoral version and tibial torsion (combined torsional malalignment) for patients with hip pain is unknown.
So, investigator hypothesized that patients with symptomatic (FAI) display significant rotation abnormalities of the acetabulum or femur and tibial and that the rotational abnormalities would portend an inferior prognosis when compared with a pair-matched control group of patients with normal range of lower limb rotation and patients with significant rotational abnormalities would have differing intraoperative hip pathology.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Age groups
- Adult
- Study population
- study will be conducted on patient aged between 18 to 45 years with radiographic imaging, history, and physical examination demonstrated evidence of FAI or labral tears; if they experienced moderate to severe pain that was unresponsive to at least 3 months of nonsurgical treatment, including physical therapy, nonsteroidal anti-inflammatory drugs, and activity modification
Key inclusion criteria (3 listed)
- • Accepted to participate in the study (signing informed consent).
Key exclusion criteria (9 listed)
- • Incomplete radiographic documentation.
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 |
|---|---|---|
| hip arthroscopyAlso: MRI, CTCT rotational profile Will be used for measurement of LL rotational abnormality. MRI will be evaluated for the presence of labral tears, chondral lesions, ligamentum teres pathology, and other soft-tissue disorders. | Procedure or surgery | – |
Primary outcome
prevalence of lower limb rotation in FAI
Time frame: baseline
determine the prevalence of abnormalities of femoral and acetabular versions and tibial torsion in symptomatic FAI Syndrome.
2 years outcome of arthroscopic treatment of 50 patients with FAI syndrome using modified Harris Hip Score (mHHS).
Time frame: 2 years
determine Outcomes of arthroscopic treatment of FAI syndrome in patients with rotational abnormalities compared with patients with normal rotation. normal rotation according to preoperative CT rotational profile: Acetabular version angle between 10⁰ to 25⁰. Femoral version angle between 10⁰ to 25⁰. Tibial torsion angle between 25⁰ to 40⁰. clinical outcome of arthroscopic treatment of patients with FAI syndrome using modified Harris Hip Score (mHHS) will be done preoperatively and postoperatively at 1.5 months, 3 months, 6 months, 1 year, and 2 years. The modified Harris hip score (mHHS) will be scored from 0 (worst functional outcome and maximum pain) to 100 points (best functional outcome and least pain)
2 years outcome of arthroscopic treatment of 50 patients with FAI syndrome using Nonarthritic Hip Score (NAHS).
Time frame: 2 years
determine Outcomes of arthroscopic treatment of FAI syndrome in patients with rotational abnormalities compared with patients with normal rotation. normal rotation according to preoperative CT rotational profile: Acetabular version angle between 10⁰ to 25⁰. Femoral version angle between 10⁰ to 25⁰. Tibial torsion angle between 25⁰ to 40⁰. clinical outcome of arthroscopic treatment of patients with FAI syndrome using Nonarthritic Hip Score (NAHS) will be done preoperatively and postoperatively at 1.5 months, 3 months, 6 months, 1 year, and 2 years. This score is divided into four domains: pain, mechanical symptoms, physical function, and level of activity. The maximum score is 100 indicating normal hip function.
2 years outcome of arthroscopic treatment of 50 patients with FAI syndrome using Hip Outcome Score-Sports Specific Subscale (HOS-SSS)
Time frame: 2 years
determine Outcomes of arthroscopic treatment of FAI syndrome in patients with rotational abnormalities compared with patients with normal rotation. normal rotation according to preoperative CT rotational profile: Acetabular version angle between 10⁰ to 25⁰. Femoral version angle between 10⁰ to 25⁰. Tibial torsion angle between 25⁰ to 40⁰. clinical outcome of arthroscopic treatment of patients with FAI syndrome using Hip Outcome Score-Sports Specific Subscale (HOS-SSS) will be done preoperatively and postoperatively at 1.5 months, 3 months, 6 months, 1 year, and 2 years. The (HOS-SSS) is a patient-completed measure that consists of "(9 scored items) in which the response options are presented as 5-point Likert scales. Scores for each subscale range from 0% (least function) to 100% (most function).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2024.
- Background: PubMed 34228156Arshad Z, Maughan HD, Sunil Kumar KH, Pettit M, Arora A, Khanduja V. Over one third of patients with symptomatic femoroacetabular impingement display femoral or acetabular version abnormalities. Knee Surg Sports Traumatol Arthrosc. 2021 Sep;29(9):2825-2836. doi: 10.1007/s00167-021-06643-3. Epub 2021 Jul 6.
- Background: PubMed 28937786Lerch TD, Todorski IAS, Steppacher SD, Schmaranzer F, Werlen SF, Siebenrock KA, Tannast M. Prevalence of Femoral and Acetabular Version Abnormalities in Patients With Symptomatic Hip Disease: A Controlled Study of 538 Hips. Am J Sports Med. 2018 Jan;46(1):122-134. doi: 10.1177/0363546517726983. Epub 2017 Sep 22.
- Background: PubMed 33249913Lerch TD, Liechti EF, Todorski IAS, Schmaranzer F, Steppacher SD, Siebenrock KA, Tannast M, Klenke FM. Prevalence of combined abnormalities of tibial and femoral torsion in patients with symptomatic hip dysplasia and femoroacetabular impingement. Bone Joint J. 2020 Dec;102-B(12):1636-1645. doi: 10.1302/0301-620X.102B12.BJJ-2020-0460.R1.
- Background: PubMed 31127313Imhoff FB, Funke V, Muench LN, Sauter A, Englmaier M, Woertler K, Imhoff AB, Feucht MJ. The complexity of bony malalignment in patellofemoral disorders: femoral and tibial torsion, trochlear dysplasia, TT-TG distance, and frontal mechanical axis correlate with each other. Knee Surg Sports Traumatol Arthrosc. 2020 Mar;28(3):897-904. doi: 10.1007/s00167-019-05542-y. Epub 2019 May 24.
- Background: PubMed 37589766Grunwald L, Histing T, Springer F, Keller G. MRI-based torsion measurement of the lower limb is a reliable and valid alternative for CT measurement: a prospective study. Knee Surg Sports Traumatol Arthrosc. 2023 Nov;31(11):4903-4909. doi: 10.1007/s00167-023-07533-6. Epub 2023 Aug 17.
- Background: PubMed 28590784Suarez-Ahedo C, Gui C, Rabe SM, Chandrasekaran S, Lodhia P, Domb BG. Acetabular Chondral Lesions in Hip Arthroscopy: Relationships Between Grade, Topography, and Demographics. Am J Sports Med. 2017 Sep;45(11):2501-2506. doi: 10.1177/0363546517708192. Epub 2017 Jun 7.
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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.
maysara mohammed contact
Questions about this trial
What is this clinical trial studying?
An observational study of Femoro Acetabular Impingement, run by Al-Azhar University.
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 9 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: opening soon, as of the sponsor's last update on 20 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact mahmoud A awad, M.Sc. of Orthopedic Surgery (01025118809, Mahmoudalmetwally.229@azhar.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of lower limb rotation in FAI (time frame: baseline). The study lists 4 primary outcomes in all. 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 NCT06420180, which also lists 6 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 20 May 2024.