NCT04243447

Brief Summary

The overarching goal of the study is to improve the surgical treatment outcomes of FAI, which is affecting an increasing number of military personnel and young active individuals in the general population. The proposed study will investigate critical patient, disease, and surgical treatment predictors of FAI surgery outcomes.

Trial Health

58
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
747

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2020

Longer than P75 for all trials

Geographic Reach
2 countries

13 active sites

Status
active not 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

First Submitted

Initial submission to the registry

January 17, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 28, 2020

Completed
5 days until next milestone

Study Start

First participant enrolled

February 2, 2020

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 29, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 29, 2025

Completed
Last Updated

October 3, 2025

Status Verified

September 1, 2025

Enrollment Period

5.8 years

First QC Date

January 17, 2020

Last Update Submit

September 29, 2025

Conditions

Femoracetabular Impingement

Keywords

Femoracetabular Impingement (FAI)Low-dose computed tomography (CT)Patient Reported Outcomes (PROs)Academic Network for Conservational Hip Outcomes Research (ANCHOR)Hip ArthroscopyOsteoarthritis (OA)

Outcome Measures

Primary Outcomes (7)

  • Hip disability and Osteoarthritis Outcome Score (HOOS)

    HOOS is a questionnaire constructed to assess patient-relevant outcomes in five separate sub-scales (pain, symptoms, activity of daily living, sport and recreation function and hip-related quality of life). HOOS is scored 0-100 with higher scores being the best outcome.

    Pre operative (Baseline), change from baseline HOOS at 3 months, change from baseline HOOS at 6 months, change from baseline HOOS at 1 year, and change from baseline HOOS at 2 year.

  • Short Form Health Survey (SF-12)

    The SF-12 is a shortened, validated, patient-reported survey of patient health with questions pulled directly from the longer form SF-36. SF-12 is scored 0-100 with higher scores being the best outcome.

    Pre operative (Baseline), change from baseline SF-12 at 3 months, change from baseline SF-12 at 6 months, change from baseline SF-12 at 1 year, and change from baseline SF-12 at 2 year

  • Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Interference (PI)

    PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. It can be used with the general population and with individuals living with chronic conditions. This specific PROMIS survey assesses a patient's pain interference. PROMIS - PI is scored from 38.7-83.8 with the lower scores being the best outcome.

    Pre operative (Baseline), change from baseline PROMIS - PI at 3 months, change from baseline PROMIS - PI at 6 months, change from baseline PROMIS -PI at 1 year, and change from baseline PROMIS - PI at 2 year

  • Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function (PF)

    PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. It can be used with the general population and with individuals living with chronic conditions. This specific PROMIS survey assesses a patient's physical function. PROMIS - PF is scored from 14.7-75.6 with the higher scores being the best outcome.

    Pre operative (Baseline), change from baseline PROMIS - PF at 3 months, change from baseline PROMIS - PF at 6 months, change from baseline PROMIS -PF at 1 year, and change from baseline PROMIS - PF at 2 year

  • Patient-Reported Outcomes Measurement Information System (PROMIS) - Mobility (M)

    PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. It can be used with the general population and with individuals living with chronic conditions. This specific PROMIS survey assesses a patient's mobility. PROMIS - M is scored from 18.2-60.2 with the higher scores being the best outcome.

    Pre operative (Baseline), change from baseline PROMIS - M at 3 months, change from baseline PROMIS - M at 6 months, change from baseline PROMIS -M at 1 year, and change from baseline PROMIS - M at 2 year

  • Patient-Reported Outcomes Measurement Information System (PROMIS) - Depression (D)

    PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. It can be used with the general population and with individuals living with chronic conditions. This specific PROMIS survey assesses a patient's depression. PROMIS - D is scored from 34.2-84.4 with the lower scores being the best outcome.

    Pre operative (Baseline), change from baseline PROMIS - D at 3 months, change from baseline PROMIS - D at 6 months, change from baseline PROMIS - D at 1 year, and change from baseline PROMIS - D at 2 year

  • Patient-Reported Outcomes Measurement Information System (PROMIS) - Anxiety (A)

    PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. It can be used with the general population and with individuals living with chronic conditions. This specific PROMIS survey assesses a patient's anxiety. PROMIS - A is scored from 32.9-84.9 with the lower scores being the best outcome.

    Pre operative (Baseline), change from baseline PROMIS - A at 3 months, change from baseline PROMIS - A at 6 months, change from baseline PROMIS - A at 1 year, and change from baseline PROMIS - A at 2 year

Secondary Outcomes (5)

  • University of California Los Angeles Activity Score (UCLA Score)

    Pre operative (Baseline), change from baseline UCLA Score at 3 months, change from baseline UCLA Score at 6 months, change from baseline UCLA Score at 1 year, and change from baseline UCLA Score at 2 year

  • International Hip Outcome Tool (iHot-12)

    Pre operative (Baseline), change from baseline iHOT-12 at 3 months, change from baseline iHOT-12 at 6 months, change from baseline iHOT-12 at 1 year, and change from baseline iHOT-12 at 2 year

  • Modified Harris Hip Score (mHHS)

    Pre operative (Baseline), change from baseline mHHS at 3 months, change from baseline mHHS at 6 months, change from baseline mHHS at 1 year, and change from baseline mHHS at 2 year

  • Brief Resilience Scale (BRS)

    Pre operative (Baseline)

  • Mobility, Stability, and Pain (MSP Question)

    Pre operative (Baseline), 3 months, 6 month

Eligibility Criteria

Age14 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Skeletally mature patients being treated surgically for FAI after failing conservative treatment.

You may qualify if:

  • Age 14 - 40 years
  • Skeletally Mature
  • Failure of 6 weeks of conservative treatment
  • Primary surgery (Hip Arthroscopic Treatment)
  • a. Surgical treatment of FAI with hip arthroscopy
  • Tonnis 0 -1 OA, with greater than 2 mm of joint space
  • Clinical diagnosis of FAI (cam or combined; alpha \>50 degrees)

You may not qualify if:

  • Not a surgical candidate
  • Skeletally Immature
  • Acetabular Dysplasia (LCEA \< 20)
  • Tonnis 2+ OA
  • Previous ipsilateral hip surgery
  • Previous major hip trauma (hip fractures, hip dislocations)
  • Additional disease processes (e.g., Avascular Necrosis (AVN), synovial disease, Ehlers-Danlos Syndrome (EDS), neuromuscular disorders)
  • Unable to consent due to mental faculty
  • Pregnant women
  • Non-English speaking patients
  • Prisoners or other vulnerable populations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

University of Colorado

Aurora, Colorado, 80045, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

University of Michigan

Ann Arbor, Michigan, 48106, United States

Location

Twin Cities Orthopedics

Edina, Minnesota, 55435, United States

Location

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Scottish Rite Hospital for Children

Dallas, Texas, 75219, United States

Location

San Antonio Military Medical Center

San Antonio, Texas, 78219, United States

Location

University of Wisconsin, Madison

Madison, Wisconsin, 53706, United States

Location

Children's Hospital of Eastern Ontario

Ottawa, Ontario, (+4) K1H 8L1, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, Canada

Location

CHU de Quebec - Universite Laval

Québec, Quebec, Canada

Location

MeSH Terms

Conditions

Femoracetabular ImpingementOsteoarthritis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsArthritisRheumatic Diseases

Study Officials

  • John C Clohisy, MD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2020

First Posted

January 28, 2020

Study Start

February 2, 2020

Primary Completion

November 29, 2025

Study Completion

November 29, 2025

Last Updated

October 3, 2025

Record last verified: 2025-09

Locations

CA(3)US(10)