Femoro-acetabular ImpingementNCT02697097
Hip Muscle Strength in FAI Versus Normal Controls
An observational study of Femoro-acetabular Impingement, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Hip Muscle Strength in femoro-acetabular impingement participants versus normal controls. To investigate the hip muscle strength in a normal control group and compare this to patients who have a diagnosis of femoro-acetabular impingement (diagnosed clinically and with confirmed radiological features). Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Femoro-acetabular Impingement
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2016to Aug 2017
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Control Arm Group - Medical Students who fit the inclusion criteria and are between ages of 18-30. FAI Comparison Group - Participants will be recruited from Young Adult Hip Clinic, meeting the defined inclusion criteria and also being between the ages of 18-30.
Who may be able to join
- Males and Females.
- Aged 18-30.
- Control group - Normal range of movement and no evidence of femoro-acetabular impingement on clinical examination (negative impingement test, no symptoms).
- Participants with femoro-acetabular impingement as diagnosed clinically and on radiological imaging for the comparison group (MRI).
Who cannot join
- Patients under the age of 18.
- Patients over the age of 30.
- Control group - evidence of underlying pathology affecting the hip, abnormal range of motion, evidence of femoro-acetabular impingement on clinical examination.
- Previous surgery of the hip joints.
- Medical history of arthritis (including rheumatoid and reactive).
- Family history of femoro-acetabular impingement (control arm participants).
- Patients who are currently experiencing or have experienced hip pain in the previous 1 year (control arm).
- Other conditions (e.g. neurological, muscular dystrophy etc) which may affect hip muscle strength.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Addenbrooke's Hospital
Cambridge, Cambridgeshire, CB2 0QQ
Arman Memarzadeh, MRCS, +447985430103, a.memarzadeh@doctors.org.uk
Muhammed O Qadir, MBChB, +447882868727, moqadir1991@hotmail.co.uk
About this study
Official title: Muscle Strength in Femoroacetabular Impingement: A Comparative Study of Patients With FAI Versus Normal Controls
Hip Muscle Strength in femoro-acetabular impingement participants versus normal controls.
To investigate the hip muscle strength in a normal control group and compare this to patients who have a diagnosis of femoro-acetabular impingement (diagnosed clinically and with confirmed radiological features).
- Conditions
- Femoro-acetabular Impingement
- Keywords
- Hip Muscle Strength, FAI
- 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 |
|---|---|---|
| Control Arm Group | Participants aged 18-30, Male and Female (10 participants each). Control group must have normal range of movement and no evidence of femoro-acetabular impingement (FAI) on clinical examination (negative impingement test, no symptoms). Other exclusions for Control Group include previous surgery to hip joint/s, history of arthritis, family history of FAI, patients who have had symptoms of hip pain in the preceding 1 year or may have other conditions which may affect the hip joint or hip muscle strength including neurological conditions or muscular dystrophy. | |
| FAI Arm Comparison Group | Participants aged 18-30, Male and Female (10 participants each). Participants with femoro-acetabular impingement as diagnosed clinically and on radiological imaging for the comparison group (MRI). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Strength on Dynamometer
Measured: 3 months
Secondary outcomes (1)
Kinematics of the Hip - Range of Movement
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2016 (estimated)
- Study startApr 2016
- Primary completionApr 2017 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoro-acetabular 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vikas Khanduja MA FRCS (Orth), Cambridge University Hospitals NHS Foundation Trust
- Investigators
- Vikas Khanduja, MA, FRCS (Orth), Principal investigator, Consultant Trauma and Orthopaedic Surgeon - Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02697097
- Sponsor's protocol ID
- AddenbrookesH
- Status last verified
- Feb 2016
- First submitted
- 24 Feb 2016
- Last updated
- 3 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscle Strength in Femoroacetabular Impingement: A Comparative Study of Patients With FAI Versus Normal Controls
- ClinicalTrials.gov ID
- NCT02697097
- Acronym / sponsor ID
- AddenbrookesH
- Conditions
- Femoro-acetabular Impingement
- Keywords
- Hip Muscle Strength, FAI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 3 Mar 2016 (estimated)
- 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.
Hip Muscle Strength in femoro-acetabular impingement participants versus normal controls.
To investigate the hip muscle strength in a normal control group and compare this to patients who have a diagnosis of femoro-acetabular impingement (diagnosed clinically and with confirmed radiological features).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm Group | – | –Participants aged 18-30, Male and Female (10 participants each). Control group must have normal range of movement and no evidence of femoro-acetabular impingement (FAI) on clinical examination (negative impingement test, no symptoms). Other exclusions for Control Group include previous surgery to hip joint/s, history of arthritis, family history of FAI, patients who have had symptoms of hip pain in the preceding 1 year or may have other conditions which may affect the hip joint or hip muscle strength including neurological conditions or muscular dystrophy. |
| FAI Arm Comparison Group | – | –Participants aged 18-30, Male and Female (10 participants each). Participants with femoro-acetabular impingement as diagnosed clinically and on radiological imaging for the comparison group (MRI). |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Control Arm Group - Medical Students who fit the inclusion criteria and are between ages of 18-30. FAI Comparison Group - Participants will be recruited from Young Adult Hip Clinic, meeting the defined inclusion criteria and also being between the ages of 18-30.
Key inclusion criteria (4 listed)
- Males and Females.
- Aged 18-30.
- Control group - Normal range of movement and no evidence of femoro-acetabular impingement on clinical examination (negative impingement test, no symptoms).
- Participants with femoro-acetabular impingement as diagnosed clinically and on radiological imaging for the comparison group (MRI).
Key exclusion criteria (8 listed)
- Patients under the age of 18.
- Patients over the age of 30.
- Control group - evidence of underlying pathology affecting the hip, abnormal range of motion, evidence of femoro-acetabular impingement on clinical examination.
- Previous surgery of the hip joints.
- Medical history of arthritis (including rheumatoid and reactive).
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
Muscle Strength on Dynamometer
Time frame: 3 months
1 secondary outcome
Kinematics of the Hip - Range of Movement
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2016.
- Individual participant dataSharing planned: No
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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.
Vikas Khanduja, MA, FRCS (Orth) principal investigator
Consultant Trauma and Orthopaedic Surgeon - Principal Investigator
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 Femoro-acetabular Impingement, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 3 Mar 2016. 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 Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vikas Khanduja, MA, FRCS (Orth) (01223 257093, vk279@cam.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle Strength on Dynamometer (time frame: 3 months). 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 3 Mar 2016.