A Single Centre Prospective Randomised Controlled Clinical Trial Comparing Total Hip Arthroplasty Performed Either Through a Posterior Approach or a Direct Anterior Approach

Medacta International SA1 site in 1 country50 target enrollmentJanuary 2010

ConditionsOsteoarthritis Rheumatoid Arthritis

Overview

Phase: N/A
Intervention: Not specified
Conditions: Osteoarthritis
Sponsor: Medacta International SA
Enrollment: 50
Locations: 1
Primary Endpoint: Compare gait kinematics and the return to normalization of gait in patients that have undergone a THA via the direct anterior approach vs. the posterior approach
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a single-centre, randomised, prospective clinical follow-up study to evaluate clinical outcome and gait analysis after total hip arthroplasty using the standard postero-lateral approach or the minimally invasive anterior approach.

Registry

clinicaltrials.gov

Start Date

January 2010

End Date

December 2015

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Medacta International SA

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Males and females aged 18-75 years at time of surgery.
•Those presenting with primary or secondary osteoarthritis and/or rheumatoid arthritis of the hip.
•Those deemed capable of giving informed consent, understanding the aims of the study and expressing willingness to comply with the post-operative review programme.
•Patients who signed the study consent form prior to surgery.

Exclusion Criteria

•Pregnant women or women who plan to conceive in the future.
•Those whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems.
•Those already treated by with a Total Hip Replacement (THR) (i.e. requiring a revision hip replacement).
•Those with co-existent ipsilateral knee disease or back problems
•Muscle contracture around the hip joint
•Individuals who have undergone organ transplant.
•Those with a known co-existent medical condition where death is anticipated within five years due to the pre-existing medical condition.
•Individuals who have had a THR on the contra-lateral side within the 6 months.
•Individuals who have undergone a THR on the contralateral side and whose outcome is considered unsatisfactory or not good. An unsatisfactory or poor result is defined as achieving a total UCLA score (including activity) \< 16 points.
•Individuals requiring bilateral hip replacement.

Outcomes

Primary Outcomes

Compare gait kinematics and the return to normalization of gait in patients that have undergone a THA via the direct anterior approach vs. the posterior approach

Time Frame: on average up to 6 weeks

Secondary Outcomes

Clinical assessment of patient using the Harris Hip Score(pre-op and 6 weeks, 6 months, 1 year after surgery)
Assessment of the improvement in quality of life and joint movement using the EuroQol-5D Score(pre-op, 1 year post-op)
Assessment of patient's level of activity using the UCLA score(pre-op and 6 weeks, 6 months, 1 year after surgery)
Radiological evaluation to assess the fixation and stability of femoral and acetabular components(pre-op and 6 weeks, 6 months, 1 year after surgery)
Strength Testing(6 weeks, 6 months and 1y after surgery)
MRI evaluation(preop-1y after surgery)
Assessment of gait kinematics(6 weeks, 12 weeks and 6 months)