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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2012 by Medacta International SA
Sponsor:
Information provided by:
Medacta International SA
ClinicalTrials.gov Identifier:
NCT01106560
First received: April 15, 2010
Last updated: August 26, 2014
Last verified: January 2012
  Purpose

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
Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Assessment of the improvement in quality of life and joint movement using the EuroQol-5D Score [ Time Frame: pre-op, 1 year post-op ] [ Designated as safety issue: No ]
  • Assessment of patient's level of activity using the UCLA score [ Time Frame: pre-op and 6 weeks, 6 months, 1 year after surgery ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Strength Testing [ Time Frame: 6 weeks, 6 months and 1y after surgery ] [ Designated as safety issue: No ]
    Muscle strength will be assessed using the MIE digital myometer (from patient #50 to patient #100)

  • MRI evaluation [ Time Frame: preop-1y after surgery ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Comparison gait analysis Anterior vs Posterior groups at fixed time point (from patient #50 to patient # 100)


Estimated Enrollment: 100
Study Start Date: January 2010
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Anterior Approach Group
(AMIS)
Procedure: Minimally Invasive Anterior Approach
Anterior minimally invasive surgery (AMIS)
Active Comparator: Posterior Approach Group Procedure: Standard postero-lateral approach

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01106560

Contacts
Contact: Mara Colombo 0041 91 6966060 ext 011 colombo@medacta.ch

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

No publications provided

ClinicalTrials.gov Identifier: NCT01106560     History of Changes
Other Study ID Numbers: P01.004.12 rev.01
Study First Received: April 15, 2010
Last Updated: August 26, 2014
Health Authority: United Kingdom: Research Ethics Committee

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

ClinicalTrials.gov processed this record on September 22, 2014