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A Randomised Trial Comparing Anterior Versus Posterior Approach in Total Hip Replacement

This study has been completed.
Information provided by (Responsible Party):
Medacta International SA Identifier:
First received: April 15, 2010
Last updated: April 11, 2016
Last verified: April 2015
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.

Condition Intervention
Osteoarthritis Rheumatoid Arthritis Procedure: Minimally Invasive Anterior Approach Procedure: Standard postero-lateral approach

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Medacta International SA:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Clinical assessment of patient using the Harris Hip Score [ Time Frame: 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 [ Time Frame: pre-op, 1 year post-op ]
  • Assessment of patient's level of activity using the UCLA score [ Time Frame: pre-op and 6 weeks, 6 months, 1 year after surgery ]
  • Radiological evaluation to assess the fixation and stability of femoral and acetabular components [ Time Frame: pre-op and 6 weeks, 6 months, 1 year after surgery ]
  • Strength Testing [ Time Frame: 6 weeks, 6 months and 1y after surgery ]
    Muscle strength will be assessed using the MIE digital myometer (from patient #50 to patient #100)

  • MRI evaluation [ Time Frame: preop-1y after surgery ]
    A MRI examination will be used to detect any damage in the hip musculature and tendons (from patient #50 to patient #100)

  • Assessment of gait kinematics [ Time Frame: 6 weeks, 12 weeks and 6 months ]
    Comparison gait analysis Anterior vs Posterior groups at fixed time point (from patient #50 to patient # 100)

Enrollment: 50
Study Start Date: January 2010
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Anterior Approach Group
Procedure: Minimally Invasive Anterior Approach
Anterior minimally invasive surgery (AMIS)
Active Comparator: Posterior Approach Group
Procedure: Standard postero-lateral approach


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01106560

United Kingdom
The Elective Orthopaedic Centre (EOC)
Epsom, United Kingdom, KT18 7EG
Sponsors and Collaborators
Medacta International SA
Principal Investigator: Richard E Field, PhD FRCS(Orth) British Orthopaedic Association
  More Information

Responsible Party: Medacta International SA Identifier: NCT01106560     History of Changes
Other Study ID Numbers: P01.004.12 rev.01
Study First Received: April 15, 2010
Last Updated: April 11, 2016

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases processed this record on June 23, 2017