NCT06420180

Brief 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).
  • 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
18mo left

Started Jul 2024

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress55%
Jul 2024Nov 2027

First Submitted

Initial submission to the registry

May 11, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 17, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

May 20, 2024

Status Verified

May 1, 2024

Enrollment Period

3 years

First QC Date

May 11, 2024

Last Update Submit

May 17, 2024

Conditions

Outcome Measures

Primary Outcomes (4)

  • prevalence of lower limb rotation in FAI

    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).

    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).

    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)

    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

Interventions

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.

Also known as: MRI, CT

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • 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.

    PMID: 34228156BACKGROUND
  • Lerch 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.

    PMID: 28937786BACKGROUND
  • Lerch 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.

    PMID: 33249913BACKGROUND
  • Imhoff 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.

    PMID: 31127313BACKGROUND
  • Grunwald 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.

    PMID: 37589766BACKGROUND
  • Suarez-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.

    PMID: 28590784BACKGROUND

MeSH Terms

Conditions

Femoracetabular Impingement

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

mahmoud A awad, M.Sc. of Orthopedic Surgery

CONTACT

maysara mohammed

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer of Orthopedic Surgery

Study Record Dates

First Submitted

May 11, 2024

First Posted

May 17, 2024

Study Start

July 1, 2024

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

November 1, 2027

Last Updated

May 20, 2024

Record last verified: 2024-05