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

Not Applicable

• Conditions: Total Hip Arthroplasty
• Interventions: Procedure: Ceramic on ceramic couple; Procedure: Percutaneous assisted approach; Procedure: Anterolateral approach; Other: Usual care

• Registration Number: NCT02032017
• Lead Sponsor: Universiteit Antwerpen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Status Verified: 2014-01
• Study First Submitted: 2014-01-07
• Study First Submitted QC: 2014-01-08
• Last Update Submitted: 2014-01-08
• Study First Posted: 2014-01-09
• Last Update Posted: 2014-01-09
• Primary Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Percutaneous assisted approach	Ceramic on ceramic couple	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.
Percutaneous assisted approach	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.
Percutaneous assisted approach	Usual care	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.
Anterolateral approach	Ceramic on ceramic couple	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.
Anterolateral approach	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.
Anterolateral approach	Usual care	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.

Primary Outcome Measures

Name	Time	Method
change in time needed for the timed get up and go test	baseline, 4 weeks, 12 weeks	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.

Secondary Outcome Measures

Name	Time	Method
surface electromyography (sEMG) of gluteus medius	12 weeks	sEMG of the gluteus medius is recorded during maximally voluntary isometric contraction and during single leg stance.
Change in hip abductor muscle strength measured by MicroFET 2	baseline, 4 weeks, 12 weeks	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.
Change in time needed to complete the 5 times sit-to-stand test	baseline, 4 weeks, 12 weeks	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.
Change in distance walked during the 6 minute walking test	baseline, 4 weeks, 12 weeks	The test measures the distance a patient can quickly walk on a flat, hard surface in a time-period of 6 minutes.
Score on the trendelenburg test	4 weeks	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: 1. Normal: the pelvis on the non-stance side can be lifted maximally during 30 seconds; 2. The pelvis on the non-stance side can be lifted, but not maximally; 3. The pelvis on the non-stance side is elevated, but not maintained for 30 seconds.; 4. No elevating of the pelvis on the non-stance side; 5. Drooping of the pelvis; 6. Non-valid response: due to hip pain or uncooperative patient
Change in knee extensor muscle strength measured by MicroFET 2	baseline, 4 weeks, 12 weeks	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.
Score on the Trendelenburg test	12 weeks	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: 1. Normal: the pelvis on the non-stance side can be lifted maximally during 30 seconds; 2. The pelvis on the non-stance side can be lifted, but not maximally; 3. The pelvis on the non-stance side is elevated, but not maintained for 30 seconds.; 4. No elevating of the pelvis on the non-stance side; 5. Drooping of the pelvis; 6. Non-valid response: due to hip pain or uncooperative patient
Change in score on the Oxford Hip Score	baseline, 4 weeks, 12 weeks	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).
Change in score on the SF-36 and it's subscales	baseline, 4 weeks, 6 weeks	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.

Trial Locations

Locations (2)

ZNA Middelheim; 🇧🇪 Wilrijk, Antwerp, Belgium

UZA; 🇧🇪 Antwerp, Belgium