Femoroacetabular ImpingementNCT03077022
Femoroacetabular Impingement (FAI): The Effectiveness of Physical Therapy
An observational study of Femoroacetabular Impingement, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The treatment of femoroacetabular impingement has evolved over the last several years. As the number of arthroscopic hip operations has risen over the last few years, so has the level controversy in regards to the appropriate initial management. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Femoroacetabular Impingement
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to Feb 2018
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects will be included if they are 18-65 years old. Patients with hip pain are routinely seen in our clinic. Patients who meet the inclusion/exclusion criteria will be offered the opportunity to participate in the study.
Who may be able to join
- symptoms consistent with femoroacetabular impingement (FAI)
- a physical exam consistent with FAI
- radiographic measurements consistent with the diagnosis including an anterior pincer lesion and/or a alpha angle greater than 55 degrees
Who cannot join
- subjects do not have FAI by physical exam and radiographic parameters
- joint space <2mm
- have had prior physical therapy for FAI
- have had prior hip surgery.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado School of Medicine
Aurora, Colorado, 80045
About this study
Official title: Effectiveness of Physical Therapy (PT) Alone vs PT Followed by Surgery to Alleviate the Symptoms of Femoroacetabular Impingement (FAI)
The treatment of femoroacetabular impingement has evolved over the last several years. As the number of arthroscopic hip operations has risen over the last few years, so has the level controversy in regards to the appropriate initial management. There have been many recent advances in clinical diagnosis, advanced imaging techniques, improved indications for surgery and improved arthroscopic techniques which have led to improved clinical outcomes, but the effectiveness of physical therapy remains unknown.
Read the detailed description
The treatment of femoroacetabular impingement has evolved over the last several years. As the number of arthroscopic hip operations has risen over the last few years, so has the level controversy in regards to the appropriate initial management. There have been many recent advances in clinical diagnosis, advanced imaging techniques, improved indications for surgery and improved arthroscopic techniques which have led to improved clinical outcomes, but the effectiveness of physical therapy remains unknown.
A paucity of evidence exists in regards to the non-operative treatment of FAI.
Several insurance companies are now requiring three to six months of physical therapy prior to approval for surgery. There is not a single study that has objectively evaluated the effectiveness of physical therapy in the avoidance of surgical intervention. The investigators plan to evaluate this using an electronic outcomes data collection system. The hypothesis is that the majority of patients will not see a significant enough improvement with physical therapy to avoid surgery, especially in a subset of patients such as those with sub spine impingement. The investigators plan to prospectively collect data for three years and monitor the outcome of each hip patient, especially those treated with physical therapy as an initial treatment and there potential avoidance of surgery.
- Conditions
- Femoroacetabular Impingement
- Medical subject headings
- Femoracetabular Impingement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Femoracetabular impingent (FAI) | Subjects will be given a prescription for physical therapy specifically for Femoracetabular impingent (FAI). They will then be followed clinically per the investigator's normal routine and the gold standard. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in sub spine impingement associated with physical therapy
The investigators plan to prospectively collect data and monitor the outcome of each hip patient. Subjects will complete a number of assessments utilizing iPads with an electronic data collection system. The data will be collected during each visit or done remotely via the internet, at which time the adjusted means from this longitudinal model will be compared.
Measured: Baseline, 6 weeks, 12 weeks, 3 months, 6 months, 1 year, and 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2017
- Study startFeb 2016
- Primary completionFeb 2018
- Study completionFeb 2018
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.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Stryker Orthopaedics
- Responsible party
- Sponsor
- Investigators
- James Genuario, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03077022
- Sponsor's protocol ID
- 17-0244
- Status last verified
- Jun 2019
- First submitted
- 6 Mar 2017
- Last updated
- 2 Jul 2019
- Results posted
- No
- 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 2 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Physical Therapy (PT) Alone vs PT Followed by Surgery to Alleviate the Symptoms of Femoroacetabular Impingement (FAI)
- ClinicalTrials.gov ID
- NCT03077022
- Acronym / sponsor ID
- 17-0244
- Conditions
- Femoroacetabular Impingement
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Stryker Orthopaedics
- Study start
- Feb 2016
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 10 Mar 2017 (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.
The treatment of femoroacetabular impingement has evolved over the last several years. As the number of arthroscopic hip operations has risen over the last few years, so has the level controversy in regards to the appropriate initial management. There have been many recent advances in clinical diagnosis, advanced imaging techniques, improved indications for surgery and improved arthroscopic techniques which have led to improved clinical outcomes, but the effectiveness of physical therapy remains unknown.
Detailed description
The treatment of femoroacetabular impingement has evolved over the last several years. As the number of arthroscopic hip operations has risen over the last few years, so has the level controversy in regards to the appropriate initial management. There have been many recent advances in clinical diagnosis, advanced imaging techniques, improved indications for surgery and improved arthroscopic techniques which have led to improved clinical outcomes, but the effectiveness of physical therapy remains unknown.
A paucity of evidence exists in regards to the non-operative treatment of FAI.
Several insurance companies are now requiring three to six months of physical therapy prior to approval for surgery. There is not a single study that has objectively evaluated the effectiveness of physical therapy in the avoidance of surgical intervention. The investigators plan to evaluate this using an electronic outcomes data collection system. The hypothesis is that the majority of patients will not see a significant enough improvement with physical therapy to avoid surgery, especially in a subset of patients such as those with sub spine impingement. The investigators plan to prospectively collect data for three years and monitor the outcome of each hip patient, especially those treated with physical therapy as an initial treatment and there potential avoidance of surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Femoracetabular impingent (FAI) | – | –Subjects will be given a prescription for physical therapy specifically for Femoracetabular impingent (FAI). They will then be followed clinically per the investigator's normal routine and the gold standard. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be included if they are 18-65 years old. Patients with hip pain are routinely seen in our clinic. Patients who meet the inclusion/exclusion criteria will be offered the opportunity to participate in the study.
Key inclusion criteria (3 listed)
- symptoms consistent with femoroacetabular impingement (FAI)
- a physical exam consistent with FAI
- radiographic measurements consistent with the diagnosis including an anterior pincer lesion and/or a alpha angle greater than 55 degrees
Key exclusion criteria (4 listed)
- subjects do not have FAI by physical exam and radiographic parameters
- joint space <2mm
- have had prior physical therapy for FAI
- have had prior hip surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in sub spine impingement associated with physical therapy
Time frame: Baseline, 6 weeks, 12 weeks, 3 months, 6 months, 1 year, and 2 years.
The investigators plan to prospectively collect data and monitor the outcome of each hip patient. Subjects will complete a number of assessments utilizing iPads with an electronic data collection system. The data will be collected during each visit or done remotely via the internet, at which time the adjusted means from this longitudinal model will be compared.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 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.
James Genuario, MD principal investigator
University of Colorado, Denver
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 University of Colorado, Denver at 1 site in United States.
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 4 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: withdrawn, as of the sponsor's last update on 2 Jul 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Change in sub spine impingement associated with physical therapy (time frame: Baseline, 6 weeks, 12 weeks, 3 months, 6 months, 1 year, and 2 years.). 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 2 Jul 2019.