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

Total Hip Arthroplasty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02032017
• Other study ID #: B300201318915
• 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. 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

• Total Hip Arthroplasty

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