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

M

Medacta

Status

Completed

Conditions

Osteoarthritis
Rheumatoid Arthritis

Treatments

Procedure: Standard postero-lateral approach
Procedure: Minimally Invasive Anterior Approach

Study type

Interventional

Funder types

Industry

Identifiers

NCT01106560
P01.004.12 rev.01

Details and patient eligibility

About

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.

Enrollment

50 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

50 participants in 2 patient groups

Anterior Approach Group
Active Comparator group
Description:
(AMIS)
Treatment:
Procedure: Minimally Invasive Anterior Approach
Posterior Approach Group
Active Comparator group
Description:
(Posterior)
Treatment:
Procedure: Standard postero-lateral approach

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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