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

NCT ID: NCT02032017

Last Updated: 2014-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Brief Summary

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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

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Conditions

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Total Hip Arthroplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Ceramic on ceramic couple

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

Usual care

Intervention Type OTHER

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.

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.

Group Type ACTIVE_COMPARATOR

Ceramic on ceramic couple

Intervention Type PROCEDURE

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.

Anterolateral approach

Intervention Type PROCEDURE

Usual care

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type PROCEDURE

Percutaneous assisted approach

Intervention Type PROCEDURE

Anterolateral approach

Intervention Type PROCEDURE

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.

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stöpler Belgium nv

UNKNOWN

Sponsor Role collaborator

Universiteit Antwerpen

OTHER

Sponsor Role lead

Responsible Party

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Claudia Hendrickx

PhD student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Claudia Hendrickx, PhD student

Role: PRINCIPAL_INVESTIGATOR

Universiteit Antwerpen

Locations

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UZA

Antwerp, Antwerp, Belgium

Site Status RECRUITING

ZNA Middelheim

Wilrijk, Antwerp, Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Claudia Hendrickx, PhD student

Role: CONTACT

0032 (0)3 821 32 92

Facility Contacts

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Claudia Hendrickx, PhD student

Role: primary

0032 (0)3 821 32 92

References

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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.

Reference Type DERIVED
PMID: 25298243 (View on PubMed)

Other Identifiers

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B300201318915

Identifier Type: -

Identifier Source: org_study_id

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