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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02032017
Enrollment
30
Registered
2014-01-09
Start date
2013-10-31
Completion date
Unknown
Last updated
2014-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Total Hip Arthroplasty

Keywords

Total Hip Arthroplasty, Gluteus medius, Approach, Rehabilitation, Functional outcome

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.

Interventions

PROCEDURECeramic 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.

PROCEDUREPercutaneous assisted approach
OTHERUsual 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.

Sponsors

Stöpler Belgium nv
CollaboratorUNKNOWN
Universiteit Antwerpen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
change in time needed for the timed get up and go testbaseline, 4 weeks, 12 weeksThe 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.

Secondary

MeasureTime frameDescription
Change in hip abductor muscle strength measured by MicroFET 2baseline, 4 weeks, 12 weeksThe 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.
Change in knee extensor muscle strength measured by MicroFET 2baseline, 4 weeks, 12 weeksThe 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.
Score on the Trendelenburg testbaselineThe 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: 1. Normal: the pelvis on the non-stance side can be lifted maximally during 30 seconds 2. The pelvis on the non-stance side can be lifted, but not maximally 3. The pelvis on the non-stance side is elevated, but not maintained for 30 seconds. 4. No elevating of the pelvis on the non-stance side 5. Drooping of the pelvis 6. Non-valid response: due to hip pain or uncooperative patient
Change in score on the Oxford Hip Scorebaseline, 4 weeks, 12 weeksThe 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).
surface electromyography (sEMG) of gluteus mediusbaselinesEMG of the gluteus medius is recorded during maximally voluntary isometric contraction and during single leg stance.
Change in time needed to complete the 5 times sit-to-stand testbaseline, 4 weeks, 12 weeksThis 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.
Change in distance walked during the 6 minute walking testbaseline, 4 weeks, 12 weeksThe test measures the distance a patient can quickly walk on a flat, hard surface in a time-period of 6 minutes.
Score on the trendelenburg test4 weeksThe 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: 1. Normal: the pelvis on the non-stance side can be lifted maximally during 30 seconds 2. The pelvis on the non-stance side can be lifted, but not maximally 3. The pelvis on the non-stance side is elevated, but not maintained for 30 seconds. 4. No elevating of the pelvis on the non-stance side 5. Drooping of the pelvis 6. Non-valid response: due to hip pain or uncooperative patient
Change in score on the SF-36 and it's subscalesbaseline, 4 weeks, 6 weeksThe 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.

Countries

Belgium

Contacts

Primary ContactClaudia Hendrickx, PhD student
Claudia.Hendrickx@uantwerpen.be0032 (0)3 821 32 92

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026