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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02032017
Other study ID # B300201318915
Secondary ID
Status Recruiting
Phase N/A
First received January 7, 2014
Last updated January 8, 2014
Start date October 2013

Study information

Verified date January 2014
Source Universiteit Antwerpen
Contact Claudia Hendrickx, PhD student
Phone 0032 (0)3 821 32 92
Email Claudia.Hendrickx@uantwerpen.be
Is FDA regulated No
Health authority Belgium: Ethics Committee
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group 50 Years to 80 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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.
Percutaneous assisted approach

Anterolateral 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.

Locations

Country Name City State
Belgium UZA Antwerp
Belgium ZNA Middelheim Wilrijk Antwerp

Sponsors (2)

Lead Sponsor Collaborator
Universiteit Antwerpen Stöpler Belgium nv

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary surface electromyography (sEMG) of gluteus medius sEMG of the gluteus medius is recorded during maximally voluntary isometric contraction and during single leg stance. baseline No
Secondary 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 No
Secondary 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 No
Secondary 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 No
Secondary 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 No
Secondary 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 No
Secondary 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 No
Secondary 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 No
Secondary 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 No
Secondary 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 No
Secondary 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 No
Secondary 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 No
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