NCT02697097

Brief 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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 24, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 3, 2016

Completed
29 days until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

March 3, 2016

Status Verified

February 1, 2016

Enrollment Period

1 year

First QC Date

February 24, 2016

Last Update Submit

February 28, 2016

Conditions

Keywords

Hip Muscle StrengthFAI

Outcome Measures

Primary Outcomes (1)

  • Muscle Strength on Dynamometer

    3 months

Secondary Outcomes (1)

  • Kinematics of the Hip - Range of Movement

    3 months

Study Arms (2)

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).

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Addenbrooke's Hospital

Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

Location

MeSH Terms

Conditions

Femoracetabular Impingement

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Vikas Khanduja, MA, FRCS (Orth)

    Consultant Trauma and Orthopaedic Surgeon - Principal Investigator

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Vikas Khanduja, MA, FRCS (Orth)

CONTACT

Arman Memarzadeh, MRCS

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 24, 2016

First Posted

March 3, 2016

Study Start

April 1, 2016

Primary Completion

April 1, 2017

Study Completion

August 1, 2017

Last Updated

March 3, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share

Locations