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

NCT01106560 | Completed

• 1 other identifier: P01.004.12 rev.01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis; Rheumatoid Arthritis

Outcome Measures

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

  on average up to 6 weeks

Secondary Outcomes (7)

• 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

  6 weeks, 6 months and 1y after surgery

Study Arms (2)

Anterior Approach Group

ACTIVE COMPARATOR

(AMIS)

Procedure: Minimally Invasive Anterior Approach

Posterior Approach Group

ACTIVE COMPARATOR

(Posterior)

Procedure: Standard postero-lateral approach

Interventions

Minimally Invasive Anterior Approach PROCEDURE

Anterior minimally invasive surgery (AMIS)

Anterior Approach Group

Standard postero-lateral approach PROCEDURE

Posterior Approach Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medacta International SA: lead

Study Sites (1)

The Elective Orthopaedic Centre (EOC)

Epsom, KT18 7EG, United Kingdom

Location

MeSH Terms

Conditions

Osteoarthritis; Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Richard E Field, PhD FRCS(Orth)

  British Orthopaedic Association

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2010
• First Posted: April 20, 2010
• Study Start: January 1, 2010
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 12, 2016

Record last verified: 2015-04

Locations

GB (1)