Clinical trial NCT02032017: Percutaneous Assisted Approach for Total Hip Replacement and it's Effect on Functional Rehabilitation.
Official title: Percutaneous Assisted Approach for Total Hip Replacement and it's Effect on Functional Rehabilitation Compared to the Anterolateral Approach.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Total Hip Arthroplasty
Keywords: Total Hip Arthroplasty
Gluteus medius
Approach
Rehabilitation
Functional outcome
Lead sponsor: Universiteit Antwerpen
Sponsor class: OTHER
Collaborators: name: Stöpler Belgium nv
First posted: 2014-01-09
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: change in time needed for the timed get up and go test
timeFrame: baseline, 4 weeks, 12 weeks
Secondary outcomes:
measure: surface electromyography (sEMG) of gluteus medius
timeFrame: baseline
measure: Change in hip abductor muscle strength measured by MicroFET 2
timeFrame: baseline, 4 weeks, 12 weeks
measure: Change in knee extensor muscle strength measured by MicroFET 2
timeFrame: baseline, 4 weeks, 12 weeks
measure: Score on the Trendelenburg test
timeFrame: baseline
measure: Change in score on the Oxford Hip Score
timeFrame: baseline, 4 weeks, 12 weeks
measure: Change in score on the SF-36 and it's subscales
timeFrame: baseline, 4 weeks, 6 weeks
measure: Change in time needed to complete the 5 times sit-to-stand test
timeFrame: baseline, 4 weeks, 12 weeks
measure: Change in distance walked during the 6 minute walking test
timeFrame: baseline, 4 weeks, 12 weeks
measure: surface electromyography (sEMG) of gluteus medius
timeFrame: 4 weeks
measure: surface electromyography (sEMG) of gluteus medius
timeFrame: 12 weeks
measure: Score on the trendelenburg test
timeFrame: 4 weeks
measure: Score on the Trendelenburg test
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Wilrijk
country: Belgium
facility: ZNA Middelheim
state: Antwerp
city: Antwerp
country: Belgium
facility: UZA
Study officials:
affiliation: Universiteit Antwerpen
name: Claudia Hendrickx, PhD student
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.