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Completed

NCT Number: NCT01106560

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Elective Orthopaedic Centre (EOC)

Epsom, KT18 7EG, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Minimally Invasive Anterior Approach

Procedure

Anterior minimally invasive surgery (AMIS)

Standard postero-lateral approach

Procedure

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Medacta International SA

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Apr 20, 2010
Registry last updated
Apr 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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