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

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

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis; Rheumatoid Arthritis
• Intervention / Treatment: Procedure: Minimally Invasive Anterior Approach; Procedure: Standard postero-lateral approach

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Epsom, United Kingdom, KT18 7EG
    • The Elective Orthopaedic Centre (EOC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Anterior Approach Group; (AMIS)	Procedure: Minimally Invasive Anterior Approach; Anterior minimally invasive surgery (AMIS)
Active Comparator: Posterior Approach Group; (Posterior)	Procedure: Standard postero-lateral approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	on average up to 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical assessment of patient using the Harris Hip Score		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		pre-op, 1 year post-op
Assessment of patient's level of activity using the UCLA score		pre-op and 6 weeks, 6 months, 1 year after surgery
Radiological evaluation to assess the fixation and stability of femoral and acetabular components		pre-op and 6 weeks, 6 months, 1 year after surgery
Strength Testing	Muscle strength will be assessed using the MIE digital myometer (from patient #50 to patient #100)	6 weeks, 6 months and 1y after surgery
MRI evaluation	A MRI examination will be used to detect any damage in the hip musculature and tendons (from patient #50 to patient #100)	preop-1y after surgery
Assessment of gait kinematics	Comparison gait analysis Anterior vs Posterior groups at fixed time point (from patient #50 to patient # 100)	6 weeks, 12 weeks and 6 months

Collaborators and Investigators

• Sponsor: Medacta International SA
• Investigators: Principal Investigator: Richard E Field, PhD FRCS(Orth), British Orthopaedic Association

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: April 15, 2010
• First Submitted That Met QC Criteria: April 19, 2010
• First Posted (Estimate): April 20, 2010

Study Record Updates

• Last Update Posted (Estimate): April 12, 2016
• Last Update Submitted That Met QC Criteria: April 11, 2016
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: P01.004.12 rev.01