Clinical trial NCT01106560: A Randomised Trial Comparing Anterior Versus Posterior Approach in Total Hip Replacement
Official title: A Single Centre Prospective Randomised Controlled Clinical Trial Comparing Total Hip Arthroplasty Performed Either Through a Posterior Approach or a Direct Anterior Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Rheumatoid Arthritis
Lead sponsor: Medacta International SA
Sponsor class: INDUSTRY
First posted: 2010-04-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.
* Individuals whose body mass index (BMI; kg/m2) \>35.
* Individuals with active or suspected infection or sepsis.
* Individuals with renal failure and/or renal insufficiency.
* Patients with severe forms of developmental dysplasia of the hip (DDH): Crowe types II, III, IV.

Primary outcomes:
measure: 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
timeFrame: on average up to 6 weeks
Secondary outcomes:
measure: Clinical assessment of patient using the Harris Hip Score
timeFrame: pre-op and 6 weeks, 6 months, 1 year after surgery
measure: Assessment of the improvement in quality of life and joint movement using the EuroQol-5D Score
timeFrame: pre-op, 1 year post-op
measure: Assessment of patient's level of activity using the UCLA score
timeFrame: pre-op and 6 weeks, 6 months, 1 year after surgery
measure: Radiological evaluation to assess the fixation and stability of femoral and acetabular components
timeFrame: pre-op and 6 weeks, 6 months, 1 year after surgery
measure: Strength Testing
timeFrame: 6 weeks, 6 months and 1y after surgery
measure: MRI evaluation
timeFrame: preop-1y after surgery
measure: Assessment of gait kinematics
timeFrame: 6 weeks, 12 weeks and 6 months
Other outcomes:
Locations:
city: Epsom
country: United Kingdom
facility: The Elective Orthopaedic Centre (EOC)
Study officials:
affiliation: British Orthopaedic Association
name: Richard E Field, PhD FRCS(Orth)
role: PRINCIPAL_INVESTIGATOR
References: