Percutaneous Assisted Approach for Total Hip Replacement and it's Effect on Functional Rehabilitation.

Percutaneous Assisted Approach for Total Hip Replacement and it's Effect on Functional Rehabilitation Compared to the Anterolateral Approach.

The purpose of this study is to investigate whether revalidation following total hip replacement through the percutaneous approach is faster or better than following the anterolateral approach. We assume this would be the case since it is possible to spare a large part of the gluteus medius muscle with the percutaneous approach.

Study Overview

• Status: Unknown
• Conditions: Total Hip Arthroplasty
• Intervention / Treatment: Procedure: Ceramic on ceramic couple; Procedure: Percutaneous assisted approach; Other: Usual care; Procedure: Anterolateral approach

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Claudia Hendrickx, PhD student; Phone Number: 0032 (0)3 821 32 92; Email: Claudia.Hendrickx@uantwerpen.be

Study Locations

• Belgium
  • Antwerp, Belgium, 2000
    • Recruiting
    • UZA
    • Contact: Claudia Hendrickx, PhD student; Phone Number: 0032 (0)3 821 32 92; Email: Claudia.Hendrickx@uantwerpen.be
    • Principal Investigator: Claudia Hendrickx, Phd Student
  • Antwerp
    • Wilrijk, Antwerp, Belgium, 2020
      • Recruiting
      • ZNA Middelheim
      • Principal Investigator: Peter Mertens, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• unilateral hip arthritis or avascular necrosis (AVN) in need for total hip replacement

Exclusion Criteria:

• Comorbidities affecting functional outcome
• Symptomatic lumbar pathology
• Need of surgery or intervention on the ipsilateral knee and/or ankle/foot
• Neurological disorders such as Parkinsonism and previous cardiovascular accidents (CVA)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Percutaneous assisted approach; In this technique, a second small incision (1 cm) at the anterior border of the femur is made. A canulla is placed underneath the muscle and used to pass the reamers in the direction of the acetabulum. There's no need to enlarge the skin incision or to release more muscle insertion to achieve good working access to the acetabulum. Two advantages can be defined: sparing of the gluteus medius muscle and safe access to the acetabulum to obtain perfect positioning of the implants.	Procedure: Ceramic on ceramic couple; All patients will get a standard total hip replacement (cementless hydroxyapatite coated cup and a titanium plasmasprayed stem) with a ceramic on ceramic (third generation biolox delta) couple. Preoperative leg length and offset are marked to reconstruct the preoperative leg length and to obtain the optimal offset.; Procedure: Percutaneous assisted approach; Other: Usual care; Both groups will receive usual care (UC) after surgery. This includes standard physiotherapy care consisting of mobilizing and strengthening techniques. All patients will receive a booklet containing information about the surgery, weight bearing after the surgery, and rehabilitation in general.
Active Comparator: Anterolateral approach; A standard transgluteal approach is used. This means a large part of the gluteus medius muscle is released to obtain good access to the acetabulum.	Procedure: Ceramic on ceramic couple; All patients will get a standard total hip replacement (cementless hydroxyapatite coated cup and a titanium plasmasprayed stem) with a ceramic on ceramic (third generation biolox delta) couple. Preoperative leg length and offset are marked to reconstruct the preoperative leg length and to obtain the optimal offset.; Other: Usual care; Both groups will receive usual care (UC) after surgery. This includes standard physiotherapy care consisting of mobilizing and strengthening techniques. All patients will receive a booklet containing information about the surgery, weight bearing after the surgery, and rehabilitation in general.; Procedure: Anterolateral approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in time needed for the timed get up and go test	The subject is asked to stand up from a chair, walk 3m to a cone, return to the chair and sit down again. The time needed to perform this test is recorded in seconds.	baseline, 4 weeks, 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
surface electromyography (sEMG) of gluteus medius	sEMG of the gluteus medius is recorded during maximally voluntary isometric contraction and during single leg stance.	baseline
Change in hip abductor muscle strength measured by MicroFET 2	The patient lies supine. Resistance is administered on the lateral side of the leg, just proximal of the knee joint. Patients will be asked for a maximally voluntary isometric contraction. The test will be repeated 3 times. The mean value will be recorded.	baseline, 4 weeks, 12 weeks
Change in knee extensor muscle strength measured by MicroFET 2	The patient is seated with the hips and knees bent 90°. Resistance is administered on the ventral side of the leg, just proximal of the ankle joint. Patients will be asked for a maximally voluntary isometric contraction. The test will be repeated 3 times. The mean value will be recorded.	baseline, 4 weeks, 12 weeks
Score on the Trendelenburg test	The patient is asked to raise one leg (sound side) and lift the non-stance side of the pelvis as high as possible for 30 seconds. The response is classified as followed: Normal: the pelvis on the non-stance side can be lifted maximally during 30 seconds; The pelvis on the non-stance side can be lifted, but not maximally; The pelvis on the non-stance side is elevated, but not maintained for 30 seconds.; No elevating of the pelvis on the non-stance side; Drooping of the pelvis; Non-valid response: due to hip pain or uncooperative patient	baseline
Change in score on the Oxford Hip Score	The Oxford Hip Score (OHS) is a disease-specific questionnaire that consists of 12 questions for the evaluation of pain and hip function in relation to various activities. Each question contains 5 quantifiable answers, leading to a total score that can range from 12 (least problems) to 60 (most problems).	baseline, 4 weeks, 12 weeks
Change in score on the SF-36 and it's subscales	The SF-36 is a generic questionnaire that contains 36 items measuring health on 8 different dimensions. These dimensions cover functional status, wellbeing and overall evaluation of health.	baseline, 4 weeks, 6 weeks
Change in time needed to complete the 5 times sit-to-stand test	This easily feasible test where the patient has to stand up and sit back down 5 times as fast as possible is a good predictor of falling. A worse score (i.e. a longer time needed to complete the test) on the 5 times sit to stand (5tSTS) implies a greater chance of falling.	baseline, 4 weeks, 12 weeks
Change in distance walked during the 6 minute walking test	The test measures the distance a patient can quickly walk on a flat, hard surface in a time-period of 6 minutes.	baseline, 4 weeks, 12 weeks
surface electromyography (sEMG) of gluteus medius	sEMG of the gluteus medius is recorded during maximally voluntary isometric contraction and during single leg stance.	4 weeks
surface electromyography (sEMG) of gluteus medius	sEMG of the gluteus medius is recorded during maximally voluntary isometric contraction and during single leg stance.	12 weeks
Score on the trendelenburg test	The patient is asked to raise one leg (sound side) and lift the non-stance side of the pelvis as high as possible for 30 seconds. The response is classified as followed: Normal: the pelvis on the non-stance side can be lifted maximally during 30 seconds; The pelvis on the non-stance side can be lifted, but not maximally; The pelvis on the non-stance side is elevated, but not maintained for 30 seconds.; No elevating of the pelvis on the non-stance side; Drooping of the pelvis; Non-valid response: due to hip pain or uncooperative patient	4 weeks
Score on the Trendelenburg test	The patient is asked to raise one leg (sound side) and lift the non-stance side of the pelvis as high as possible for 30 seconds. The response is classified as followed: Normal: the pelvis on the non-stance side can be lifted maximally during 30 seconds; The pelvis on the non-stance side can be lifted, but not maximally; The pelvis on the non-stance side is elevated, but not maintained for 30 seconds.; No elevating of the pelvis on the non-stance side; Drooping of the pelvis; Non-valid response: due to hip pain or uncooperative patient	12 weeks

Collaborators and Investigators

• Sponsor: Universiteit Antwerpen
• Collaborators: Stöpler Belgium nv
• Investigators: Principal Investigator: Claudia Hendrickx, PhD student, Universiteit Antwerpen

Publications and helpful links

General Publications

• Hendrickx C, De Hertogh W, Van Daele U, Mertens P, Stassijns G. Effect of percutaneous assisted approach on functional rehabilitation for total hip replacement compared to anterolateral approach: study protocol for a randomized controlled trial. Trials. 2014 Oct 8;15:392. doi: 10.1186/1745-6215-15-392.

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Anticipated): December 1, 2014

Study Registration Dates

• First Submitted: January 7, 2014
• First Submitted That Met QC Criteria: January 8, 2014
• First Posted (Estimate): January 9, 2014

Study Record Updates

• Last Update Posted (Estimate): January 9, 2014
• Last Update Submitted That Met QC Criteria: January 8, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: Rehabilitation; Total Hip Arthroplasty; Gluteus medius; Functional outcome; Approach
• Other Study ID Numbers: B300201318915