NCT02032017

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 7, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 9, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Last Updated

January 9, 2014

Status Verified

January 1, 2014

Enrollment Period

1.2 years

First QC Date

January 7, 2014

Last Update Submit

January 8, 2014

Conditions

Total Hip Arthroplasty

Keywords

Total Hip ArthroplastyGluteus mediusApproachRehabilitationFunctional outcome

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (12)

  • surface electromyography (sEMG) of gluteus medius

    baseline

  • Change in hip abductor muscle strength measured by MicroFET 2

    baseline, 4 weeks, 12 weeks

  • Change in knee extensor muscle strength measured by MicroFET 2

    baseline, 4 weeks, 12 weeks

  • Score on the Trendelenburg test

    baseline

  • Change in score on the Oxford Hip Score

    baseline, 4 weeks, 12 weeks

  • +7 more secondary outcomes

Study Arms (2)

Percutaneous assisted approach

EXPERIMENTAL

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 coupleProcedure: Percutaneous assisted approachOther: Usual care

Anterolateral approach

ACTIVE COMPARATOR

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 coupleProcedure: Anterolateral approachOther: Usual care

Interventions

Ceramic on ceramic couplePROCEDURE

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 approachPercutaneous assisted approach
Percutaneous assisted approachPROCEDURE
Percutaneous assisted approach
Anterolateral approachPROCEDURE
Anterolateral approach
Usual careOTHER

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 approachPercutaneous assisted approach

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UZA

Antwerp, Antwerp, 2000, Belgium

RECRUITING

ZNA Middelheim

Wilrijk, Antwerp, 2020, Belgium

RECRUITING

Related Publications (1)

  • 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.

    PMID: 25298243DERIVED

Study Officials

  • Claudia Hendrickx, PhD student

    Universiteit Antwerpen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Claudia Hendrickx, PhD student

CONTACT

0032 (0)3 821 32 92Claudia.Hendrickx@uantwerpen.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

January 7, 2014

First Posted

January 9, 2014

Study Start

October 1, 2013

Primary Completion

December 1, 2014

Last Updated

January 9, 2014

Record last verified: 2014-01

Locations

BE(2)