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Screening Muscle Strength in Arthroscopic Surgery of the Hip (SMASH)

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ClinicalTrials.gov Identifier: NCT03728920
Recruitment Status : Unknown
Verified October 2018 by Arman Memarzadeh, Cambridge University Hospitals NHS Foundation Trust.
Recruitment status was:  Not yet recruiting
First Posted : November 2, 2018
Last Update Posted : November 2, 2018
Sponsor:
Information provided by (Responsible Party):
Arman Memarzadeh, Cambridge University Hospitals NHS Foundation Trust

Brief 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.

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.


Condition or disease Intervention/treatment
Femoroacetabular Impingement Other: Muscle strength measurement

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Screening Muscle Strength in Arthroscopic Surgery of the Hip
Estimated Study Start Date : January 10, 2019
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : December 1, 2019

Intervention Details:
  • Other: Muscle strength measurement
    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.


Primary Outcome Measures :
  1. Hip Outcome Score [ Time Frame: 6 months post-operatively ]
    Patient reported outcome measure to assess the success of hip arthroscopy



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Young adult patients suffering with femoroacetabular impingement, prior to the development of arthritis
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
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Responsible Party: Arman Memarzadeh, Clinical and Research Fellow, Cambridge University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03728920    
Other Study ID Numbers: SMASH V9
First Posted: November 2, 2018    Key Record Dates
Last Update Posted: November 2, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Femoracetabular Impingement
Joint Diseases
Musculoskeletal Diseases
Pathologic Processes