Femoroacetabular ImpingementSMASHNCT03728920
Screening Muscle Strength in Arthroscopic Surgery of the Hip
An observational study of Femoroacetabular Impingement, run by Cambridge University Hospitals NHS Foundation Trust.
Trial summary
Hypothesis We hypothesise that hip muscle strength can predict the outcome of hip arthroscopy. A relationship between strength and outcome can improve the success of the procedure and avoid unnecessary and potentially harmful surgery. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Femoroacetabular Impingement
- What is being tested?
- Muscle strength measurement
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 10 Jan 2019to 1 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 45 years
- All sexes
- No healthy volunteers
- Adult
Study population: Young adult patients suffering with femoroacetabular impingement, prior to the development of arthritis
Who may be able to join
- Patients aged 18-45 years with evidence of FAI on MRI scan (the standard method of imaging of the condition in the NHS)
- Competent to consent to study participation
Who cannot join
- Established osteoarthritis with evidence of osteophytes (Tonnis grade >2)
- Patient with hip dysplasia (centre-edge-angle <20 degrees)
- Patients with full thickness cartilage (chondral) lesions
- Previous diagnosis of mental health disorder
- Failure to comply with Addenbrooke's hospital post-operative rehabilitation exercises tailored to hip arthroscopy
About this study
Hypothesis We hypothesise that hip muscle strength can predict the outcome of hip arthroscopy. A relationship between strength and outcome can improve the success of the procedure and avoid unnecessary and potentially harmful surgery.
Objectives The primary objective is to evaluate the relationship between hip muscle strength and outcomes of hip arthroscopy. The secondary objective is to determine a 'threshold strength' above which the operation becomes successful. If this relationship is established, it would launching a randomised control trial with targeted physiotherapy as the intervention.
Read more
Background Hip arthroscopy is key-hole surgery to the hip joint which is performed for femoroacetabular impingement; a condition which describes a shape mismatch between the ball-and-socket hip joint. The number of procedures is increasing, however, studies have shown success in only half of patients undergoing the procedure.
Several factors have been linked with outcomes; however, the influence of muscle strength has never been investigated. We performed a systematic review of this topic, revealing that muscles around affected hips are significantly weaker. We also developed a standardised protocol for the measurement of muscle strength.
Plan Patients awaiting hip arthroscopy will undergo muscle strength testing pre- and post-operatively. There will be no deviation of treatment from their NHS care. Validated outcome measure questionnaires will be completed at five months post-operatively. Magnetic resonance imaging and electromyography tests will be performed on a subset of patients post-operatively.
- Conditions
- Femoroacetabular Impingement
- Being tested
- Muscle strength measurement
- Medical subject headings
- Femoracetabular Impingement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle strength measurementOther
Patients awaiting hip arthroscopy will undergo muscle strength testing pre- and post-operatively. There will be no deviation of treatment from their NHS care. Validated outcome measure questionnaires will be completed at five months post-operatively. Magnetic resonance imaging and electromyography tests will be performed on a subset of patients post-operatively.
What is being measured
The primary outcome is the main question the study is designed to answer.
Hip Outcome Score
Patient reported outcome measure to assess the success of hip arthroscopy
Measured: 6 months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2018
- Study start10 Jan 2019 (estimated)
- Primary completion1 Aug 2019 (estimated)
- Study completion1 Dec 2019 (estimated)
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
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arman Memarzadeh, Cambridge University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03728920
- Sponsor's protocol ID
- SMASH V9
- Acronym
- SMASH
- Status last verified
- Oct 2018
- First submitted
- 31 Oct 2018
- Last updated
- 2 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening Muscle Strength in Arthroscopic Surgery of the Hip
- ClinicalTrials.gov ID
- NCT03728920
- Acronym / sponsor ID
- SMASH / SMASH V9
- Conditions
- Femoroacetabular Impingement
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 10 Jan 2019 (estimated)
- Primary completion
- 1 Aug 2019 (estimated)
- Study completion
- 1 Dec 2019 (estimated)
- First posted
- 2 Nov 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.
Hypothesis We hypothesise that hip muscle strength can predict the outcome of hip arthroscopy. A relationship between strength and outcome can improve the success of the procedure and avoid unnecessary and potentially harmful surgery.
Objectives The primary objective is to evaluate the relationship between hip muscle strength and outcomes of hip arthroscopy. The secondary objective is to determine a 'threshold strength' above which the operation becomes successful. If this relationship is established, it would launching a randomised control trial with targeted physiotherapy as the intervention.
Background Hip arthroscopy is key-hole surgery to the hip joint which is performed for femoroacetabular impingement; a condition which describes a shape mismatch between the ball-and-socket hip joint. The number of procedures is increasing, however, studies have shown success in only half of patients undergoing the procedure.
Several factors have been linked with outcomes; however, the influence of muscle strength has never been investigated. We performed a systematic review of this topic, revealing that muscles around affected hips are significantly weaker. We also developed a standardised protocol for the measurement of muscle strength.
Plan Patients awaiting hip arthroscopy will undergo muscle strength testing pre- and post-operatively. There will be no deviation of treatment from their NHS care. Validated outcome measure questionnaires will be completed at five months post-operatively. Magnetic resonance imaging and electromyography tests will be performed on a subset of patients post-operatively.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Young adult patients suffering with femoroacetabular impingement, prior to the development of arthritis
Key inclusion criteria (2 listed)
- Patients aged 18-45 years with evidence of FAI on MRI scan (the standard method of imaging of the condition in the NHS)
- Competent to consent to study participation
Key exclusion criteria (5 listed)
- Established osteoarthritis with evidence of osteophytes (Tonnis grade >2)
- Patient with hip dysplasia (centre-edge-angle <20 degrees)
- Patients with full thickness cartilage (chondral) lesions
- Previous diagnosis of mental health disorder
- Failure to comply with Addenbrooke's hospital post-operative rehabilitation exercises tailored to hip arthroscopy
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 |
|---|---|---|
| Muscle strength measurementPatients awaiting hip arthroscopy will undergo muscle strength testing pre- and post-operatively. There will be no deviation of treatment from their NHS care. Validated outcome measure questionnaires will be completed at five months post-operatively. Magnetic resonance imaging and electromyography tests will be performed on a subset of patients post-operatively. | Other | – |
Primary outcome
Hip Outcome Score
Time frame: 6 months post-operatively
Patient reported outcome measure to assess the success of hip arthroscopy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2018.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Femoroacetabular Impingement, run by Cambridge University Hospitals NHS Foundation Trust.
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 2 inclusion and 5 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 2 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Hip Outcome Score (time frame: 6 months post-operatively). 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 Nov 2018.