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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04502043
Other study ID # SchulthessKlinik
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 1, 2019
Est. completion date March 2024

Study information

Verified date December 2023
Source Schulthess Klinik
Contact Nicola C Casartelli, PhD
Phone 0443857971
Email nicola.casartelli@kws.ch
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Description:

Patients with a diagnosis of FAIS will be recruited from 2 clinical centers and will receive exercise therapy (study intervention). Exercise therapy is a semi-standardized intervention and will last 12 weeks (3 months). Hip pain, function and quality of life will be assessed using a patient-reported questionnaire at baseline, 3, 6 and 12 months' follow-up. Hip joint contact pressure will be evaluated using motion analysis and modelling at baseline, 3 and 12 months' follow-up. Hip morphology will be evaluated using imaging at baseline and hip surgery rate will be evaluated at 6 and 12 months' follow-up.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date March 2024
Est. primary completion date March 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Exercise therapy
Education Hip-specific strengthening exercises Functional lower limb strengthening exercises Core stability exercises Postural balance exercises

Locations

Country Name City State
Switzerland Schulthess Clinic Zurich

Sponsors (2)

Lead Sponsor Collaborator
Schulthess Klinik Kantonsspital Winterthur KSW

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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 12 months' follow-up
Secondary 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 3 months' follow-up
Secondary Change in hip joint contact stress Hip joint contact pressure will be assessed using modelling Baseline to 3 months' follow-up
Secondary Change in hip joint contact stress Hip joint contact pressure will be assessed using modelling Baseline to 12 months' follow-up
Secondary Hip morphology Hip morphology will be assessed using imaging Baseline
Secondary Change in sport activity level Sport activity level will be assessed using the Hip Sports Activity Scale Baseline to 3 months' follow-up
Secondary Change in sport activity level Sport activity level will be assessed using the Hip Sports Activity Scale Baseline to 6 months' follow-up
Secondary Change in sport activity level Sport activity level will be assessed using the Hip Sports Activity Scale Baseline to 12 months' follow-up
Secondary Hip surgery rate Number of patients who will decide to undergo hip surgery 6 months' follow-up
Secondary Hip surgery rate Number of patients who will decide to undergo hip surgery 12 months' follow-up
Secondary Dropout Number of patients who will not complete the non-surgical intervention protocol 3 months' follow-up
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05256628 - Early Versus Delayed Weightbearing in Femoroacetabular Impingement Syndrome Patients N/A
Completed NCT04599296 - Postoperative Hip Bracing After Hip Arthroscopy N/A
Completed NCT04946513 - Hip Arthroscopy Improves Muscle Volumes in Patients With Femoroacetabular Impingement Syndrome
Recruiting NCT05927935 - First-line Treatment for Femoroacetabular Impingement Syndrome N/A