Effect of Lower Limb Rotation on Clinical Outcomes After Arthroscopic Management in Patients With Symptomatic Femoroacetabular Impingement Syndrome

May 17, 2024 updated by: mahmoud ahmed awad elmetwally, Al-Azhar University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: maysara mohammed
  • Phone Number: 01099003667

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

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

Description

Inclusion Criteria:

  • • 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

Exclusion Criteria:

  • • 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.
    • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline
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
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
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).
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Azhar University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2024

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

November 1, 2027

Study Registration Dates

First Submitted

May 11, 2024

First Submitted That Met QC Criteria

May 16, 2024

First Posted (Actual)

May 17, 2024

Study Record Updates

Last Update Posted (Actual)

May 20, 2024

Last Update Submitted That Met QC Criteria

May 17, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • lower limb rotation on FAI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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