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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01106560
Recruitment Status : Completed
First Posted : April 20, 2010
Last Update Posted : April 12, 2016
Information provided by (Responsible Party):
Medacta International SA

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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : January 2010
Primary Completion Date : December 2015
Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. Clinical assessment of patient using the Harris Hip Score [ Time Frame: pre-op and 6 weeks, 6 months, 1 year after surgery ]
  2. Assessment of the improvement in quality of life and joint movement using the EuroQol-5D Score [ Time Frame: pre-op, 1 year post-op ]
  3. Assessment of patient's level of activity using the UCLA score [ Time Frame: pre-op and 6 weeks, 6 months, 1 year after surgery ]
  4. 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 ]
  5. 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)

  6. 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)

  7. 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)

Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: Medacta International SA Identifier: NCT01106560     History of Changes
Other Study ID Numbers: P01.004.12 rev.01
First Posted: April 20, 2010    Key Record Dates
Last Update Posted: April 12, 2016
Last Verified: April 2015

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases