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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

Tracking Information
First Submitted Date October 31, 2018
First Posted Date November 2, 2018
Last Update Posted Date November 2, 2018
Estimated Study Start Date January 10, 2019
Estimated Primary Completion Date August 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 31, 2018)
Hip Outcome Score [ Time Frame: 6 months post-operatively ]
Patient reported outcome measure to assess the success of hip arthroscopy
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Screening Muscle Strength in Arthroscopic Surgery of the Hip
Official Title Screening Muscle Strength in Arthroscopic Surgery of the Hip
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Young adult patients suffering with femoroacetabular impingement, prior to the development of arthritis
Condition Femoroacetabular Impingement
Intervention 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.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: October 31, 2018)
30
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 1, 2019
Estimated Primary Completion Date August 1, 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03728920
Other Study ID Numbers SMASH V9
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Arman Memarzadeh, Cambridge University Hospitals NHS Foundation Trust
Study Sponsor Cambridge University Hospitals NHS Foundation Trust
Collaborators Not Provided
Investigators Not Provided
PRS Account Cambridge University Hospitals NHS Foundation Trust
Verification Date October 2018