Femoroacetabular ImpingementNCT03669471
Muscular and Functional Performance in FAIS Patients
An observational study of Femoroacetabular Impingement, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
Following hip arthroscopy for femoroacetabular impingement syndrome (FAIS) decreased hip muscle strength for adduction, extension, flexion, and external rotation including impaired functional performance have been observed. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Femoroacetabular Impingement
- What is being tested?
- Testing of performance
- How many people
- 45 participants
- Where
- 1 siteDenmark
- Study dates
- 13 Sep 2018to 15 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Study population: Subjects who have undergone hip arthroscopy for femoroacetabular impingement syndrome during the preceding 6-30 months in the Greater Copehangen Area
Who may be able to join
- Male/female at the age of 18-40 years at the time of surgery
- Undergone hip arthroscopy for FAIS during the previous 6-30 months (surgical procedure: cam resection and labral surgery)
- Pre-operative cam morphology specified as an alpha angle ≥55°
Who cannot join
- Pre-surgery joint space width <3 mm
- Any of the following surgical procedures at any time: extra articular surgery of the hip joint (except capsular closure), microfracture, periacetabular osteotomy, and surgery of the ligamentum teres; previous hip arthroscopy in the same hip joint; previous hip pathology such as Perthes' disease, slipped upper femoral epiphysis, hip dysplasia (Lateral Center Edge Angle <25°), and/or avascular necrosis; Any rheumatoid disease in the hip joint such as synovial chondromatosis.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Testing and exercise-based intervention will be conducted at Hvidovre Hospital
Copenhagen
About this study
Official title: Muscular and Functional Hop Test Performance in Femoroacetabular Impingement Syndrome Patients 6-30 Months Post Hip Arthroscopy - a Cross-sectional Study
Following hip arthroscopy for femoroacetabular impingement syndrome (FAIS) decreased hip muscle strength for adduction, extension, flexion, and external rotation including impaired functional performance have been observed. However, no studies are lacking on more demanding muscular and functional parameters such as hip muscle rate of force development and reactive strength index. Information on such muscular properties following hip arthroscopy for FAIS may help guide future planning of post-operative rehabilitation strategies.
This is a cross-sectional study with an embedded prospective non-randomized study. The aim of the cross-sectional study is to investigate hip muscle function and functional performance in patients who have undergone hip arthroscopy for FAIS during the preceding 6-30 months.
Read more
The aim of the prospective non-randomized study is to investigate the effect of a 12-week structured and supervised physiotherapy-led intervention aiming at improving hip muscular function on self-reported hip and groin function including hip muscle function and functional performance.
Forty-five subjects from the Capital Region with an age of 18-40, who have undergone a hip arthroscopy for FAIS during the last 6-30 months, will be included in the cross-sectional study. Additionally, all included subjects will be offered to take part in the prospective non-randomized study consisting of 12 weeks of supervised and structured physiotherapy-led treatment.
The below measures will be obtained at baseline, and at 12-weeks follow-up if subjects are included in the prospective study. All testing, and supervised physiotherapy-led treatment, will be performed at Hvidovre Hospital:
- Hip muscle function
- Single leg jump performance
- Self-reported hip and groin function
- Evaluation of return to sport
- Evaluation of satisfaction regarding usual-care post-operative rehabilitation
- Conditions
- Femoroacetabular Impingement
- Being tested
- Testing of performance
- Medical subject headings
- Femoracetabular Impingement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testing of performanceOther
Also called Exercise-based treatment
The cross-sectional evaluation will involve assessment of:
- Hip muscle function
- Single leg jump performance
- Self-reported hip and groin function
- Evaluation of return to sport
- Evaluation of satisfaction regarding usual-care post-operative rehabilitation
The exercise-based treatment will involve criteria-based physiotherapy aiming at improving muscle function around the hip and trunk.
| Study group | Role | What they receive |
|---|---|---|
| FAIS group | Subjects who have had a hip arthroscopy for femoroacetabular impingement during the preceding 6-30 months Receives: Other: Testing of performance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak force
Peak isometric hip torque (Nm/kg) of abduction, adduction, extension, and flexion
Measured: Baseline (week 0)
Rate of force development
0-100 ms and 0-200 ms rate of torque development (Nm/s/kg) of abduction, adduction, extension, and flexion
Measured: Baseline (week 0)
Self-reported hip and groin function (subjects included in prospective study)
Obtained using the Copenhagen Hip and Groin Outcome Score (HAGOS); Scale from 0 (extreme hip and groin problems) to 100 (no hip and groin problems)
Measured: Baseline (week 0) and follow-up (week 12)
Secondary outcomes (7)
Single leg jump performance
Reactive strength index obtained during a single leg drop jump test
Measured: Baseline (week 0)
Self-reported hip and groin function
Obtained using the Copenhagen Hip and Groin Outcome Score (HAGOS); Scale from 0 (extreme hip and groin problems) to 100 (no hip and groin problems)
Measured: Baseline (week 0)
Return to sport
Obtained using a return to sport questionnaire; Scale: Preinjury sport at preinjury level vs. not preinjury sport at preinjury level.
Measured: Baseline (week 0)
Satisfaction regarding usual-care post-operative rehabilitation
Obtained using a questionnaire; Scale: Satisfied with regular post-operative rehabilitation vs. not satisfied with post-operative rehabilitation.
Measured: Baseline (week 0)
Change in Peak force (subjects included in prospective study)
Peak isometric hip torque (Nm/kg) of abduction, adduction, extension, and flexion
Measured: Baseline (week 0) and follow-up (week 12)
Change in rate of force development (subjects included in prospective study)
0-100 ms and 0-200 ms rate of torque development (Nm/s/kg) of abduction, adduction, extension, and flexion
Measured: Baseline (week 0) and follow-up (week 12)
Change in Single leg jump performance (subjects included in prospective study)
Reactive strength index obtained during a single leg drop jump test
Measured: Baseline (week 0) and follow-up (week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2018
- Study start13 Sep 2018
- Primary completion10 Sep 2019
- Study completion15 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoroacetabular ImpingementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lasse Ishøi, Hvidovre University Hospital
- Investigators
- Lasse Ishøi, Principal investigator, Sports Orthopedic Research Center - Copenhagen (SORC-C), Ortopædkirurgisk Afdeling, Hvidovre Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03669471
- Sponsor's protocol ID
- FAIS2018
- Status last verified
- Dec 2019
- First submitted
- 7 Sep 2018
- Last updated
- 17 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscular and Functional Hop Test Performance in Femoroacetabular Impingement Syndrome Patients 6-30 Months Post Hip Arthroscopy - a Cross-sectional Study
- ClinicalTrials.gov ID
- NCT03669471
- Acronym / sponsor ID
- FAIS2018
- Conditions
- Femoroacetabular Impingement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- 13 Sep 2018 (actual)
- Primary completion
- 10 Sep 2019 (actual)
- Study completion
- 15 Dec 2019 (actual)
- First posted
- 13 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Following hip arthroscopy for femoroacetabular impingement syndrome (FAIS) decreased hip muscle strength for adduction, extension, flexion, and external rotation including impaired functional performance have been observed. However, no studies are lacking on more demanding muscular and functional parameters such as hip muscle rate of force development and reactive strength index. Information on such muscular properties following hip arthroscopy for FAIS may help guide future planning of post-operative rehabilitation strategies.
This is a cross-sectional study with an embedded prospective non-randomized study. The aim of the cross-sectional study is to investigate hip muscle function and functional performance in patients who have undergone hip arthroscopy for FAIS during the preceding 6-30 months.
The aim of the prospective non-randomized study is to investigate the effect of a 12-week structured and supervised physiotherapy-led intervention aiming at improving hip muscular function on self-reported hip and groin function including hip muscle function and functional performance.
Forty-five subjects from the Capital Region with an age of 18-40, who have undergone a hip arthroscopy for FAIS during the last 6-30 months, will be included in the cross-sectional study. Additionally, all included subjects will be offered to take part in the prospective non-randomized study consisting of 12 weeks of supervised and structured physiotherapy-led treatment.
The below measures will be obtained at baseline, and at 12-weeks follow-up if subjects are included in the prospective study. All testing, and supervised physiotherapy-led treatment, will be performed at Hvidovre Hospital:
- Hip muscle function
- Single leg jump performance
- Self-reported hip and groin function
- Evaluation of return to sport
- Evaluation of satisfaction regarding usual-care post-operative rehabilitation
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FAIS group | – | Other: Testing of performanceSubjects who have had a hip arthroscopy for femoroacetabular impingement during the preceding 6-30 months |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Subjects who have undergone hip arthroscopy for femoroacetabular impingement syndrome during the preceding 6-30 months in the Greater Copehangen Area
Key inclusion criteria (3 listed)
- Male/female at the age of 18-40 years at the time of surgery
- Undergone hip arthroscopy for FAIS during the previous 6-30 months (surgical procedure: cam resection and labral surgery)
- Pre-operative cam morphology specified as an alpha angle ≥55°
Key exclusion criteria (2 listed)
- Pre-surgery joint space width <3 mm
- Any of the following surgical procedures at any time: extra articular surgery of the hip joint (except capsular closure), microfracture, periacetabular osteotomy, and surgery of the ligamentum teres; previous hip arthroscopy in the same hip joint; previous hip pathology such as Perthes' disease, slipped upper femoral epiphysis, hip dysplasia (Lateral Center Edge Angle <25°), and/or avascular necrosis; Any rheumatoid disease in the hip joint such as synovial chondromatosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Testing of performanceAlso: Exercise-based treatmentThe cross-sectional evaluation will involve assessment of: 1. Hip muscle function 2. Single leg jump performance 3. Self-reported hip and groin function 4. Evaluation of return to sport 5. Evaluation of satisfaction regarding usual-care post-operative rehabilitation The exercise-based treatment will involve criteria-based physiotherapy aiming at improving muscle function around the hip and trunk. | Other | FAIS group |
Primary outcome
Peak force
Time frame: Baseline (week 0)
Peak isometric hip torque (Nm/kg) of abduction, adduction, extension, and flexion
Rate of force development
Time frame: Baseline (week 0)
0-100 ms and 0-200 ms rate of torque development (Nm/s/kg) of abduction, adduction, extension, and flexion
Self-reported hip and groin function (subjects included in prospective study)
Time frame: Baseline (week 0) and follow-up (week 12)
Obtained using the Copenhagen Hip and Groin Outcome Score (HAGOS); Scale from 0 (extreme hip and groin problems) to 100 (no hip and groin problems)
7 secondary outcomes
Single leg jump performance
Time frame: Baseline (week 0)
Self-reported hip and groin function
Time frame: Baseline (week 0)
Return to sport
Time frame: Baseline (week 0)
Satisfaction regarding usual-care post-operative rehabilitation
Time frame: Baseline (week 0)
Change in Peak force (subjects included in prospective study)
Time frame: Baseline (week 0) and follow-up (week 12)
Change in rate of force development (subjects included in prospective study)
Time frame: Baseline (week 0) and follow-up (week 12)
Change in Single leg jump performance (subjects included in prospective study)
Time frame: Baseline (week 0) and follow-up (week 12)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lasse Ishøi principal investigator
Sports Orthopedic Research Center - Copenhagen (SORC-C), Ortopædkirurgisk Afdeling, Hvidovre Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Femoroacetabular Impingement, run by Hvidovre University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak force (time frame: Baseline (week 0)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2019.