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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01106560
• Other study ID #: P01.004.12 rev.01
• Status: Completed
• Phase: N/A
• First received: April 15, 2010
• Last updated: April 11, 2016
• Start date: January 2010
• Est. completion date: December 2015

Study information

• Verified date: April 2015
• Source: Medacta International SA
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Osteoarthritis
• Rheumatoid Arthritis

Intervention

Procedure:
• Minimally Invasive Anterior Approach
Anterior minimally invasive surgery (AMIS)
• Standard postero-lateral approach

Locations

Country	Name	City	State
United Kingdom	The Elective Orthopaedic Centre (EOC)	Epsom

Sponsors (1)

Lead Sponsor	Collaborator
Medacta International SA

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Clinical assessment of patient using the Harris Hip Score		pre-op and 6 weeks, 6 months, 1 year after surgery	No
Secondary	Assessment of the improvement in quality of life and joint movement using the EuroQol-5D Score		pre-op, 1 year post-op	No
Secondary	Assessment of patient's level of activity using the UCLA score		pre-op and 6 weeks, 6 months, 1 year after surgery	No
Secondary	Radiological evaluation to assess the fixation and stability of femoral and acetabular components		pre-op and 6 weeks, 6 months, 1 year after surgery	No
Secondary	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	No
Secondary	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	No
Secondary	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	No