NCT04502043

Brief Summary

The aim of the clinical trial is to investigate the characteristics of patients, who respond vs. not respond to exercise therapy for the nonsurgical management of femoroacetabular impingement syndrome (FAIS).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

June 14, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2019

Completed
1 year until next milestone

First Posted

Study publicly available on registry

August 6, 2020

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

December 19, 2023

Status Verified

December 1, 2023

Enrollment Period

4.6 years

First QC Date

June 14, 2019

Last Update Submit

December 18, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in hip pain, function and quality of life

    Hip pain, function and quality of life will be assessed using the International Hip Outcome Tool - 33 Items

    Baseline to 6 months' follow-up

Secondary Outcomes (11)

  • Change in hip pain, function and quality of life

    Baseline to 12 months' follow-up

  • Change in hip pain, function and quality of life

    Baseline to 3 months' follow-up

  • Change in hip joint contact stress

    Baseline to 3 months' follow-up

  • Change in hip joint contact stress

    Baseline to 12 months' follow-up

  • Hip morphology

    Baseline

  • +6 more secondary outcomes

Study Arms (1)

Exercise therapy

EXPERIMENTAL

Exercise therapy consists of improving dynamic hip joint stability by means of hip-specific and functional lower limb strengthening, core stability and postural balance exercises.

Other: Exercise therapy

Interventions

* Education * Hip-specific strengthening exercises * Functional lower limb strengthening exercises * Core stability exercises * Postural balance exercises

Exercise therapy

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age: 18 to 50 years;
  • Diagnosis of FAIS;
  • Availability of magnetic resonance arthrography and anteroposterior pelvic radiography of the involved hip;
  • Signed informed consent form.

You may not qualify if:

  • Previous hip surgery;
  • Any surgery on the lower extremities in the last 6 months;
  • Hip dysplasia: lateral center edge angle \<25°;
  • Hip osteoarthritis: Tönnis grade \>1;
  • BMI: \>35 kg/m2;
  • Significant cardiopulmonary diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Schulthess Clinic

Zurich, 8008, Switzerland

RECRUITING

MeSH Terms

Conditions

Femoracetabular Impingement

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Study Officials

  • Nicola C Casartelli, PhD

    Schulthess Klinik

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicola C Casartelli, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2019

First Posted

August 6, 2020

Study Start

August 1, 2019

Primary Completion

March 1, 2024

Study Completion

March 1, 2024

Last Updated

December 19, 2023

Record last verified: 2023-12

Locations