Total Hip ArthroplastyNCT02032017
Percutaneous Assisted Approach for Total Hip Replacement and it's Effect on Functional Rehabilitation.
A study testing Ceramic on ceramic couple, Percutaneous assisted approach and Anterolateral approach in people with Total Hip Arthroplasty, run by Universiteit Antwerpen at 2 sites in Belgium.
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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Total Hip Arthroplasty
- What is being tested?
- Ceramic on ceramic couple, Percutaneous assisted approach and Anterolateral approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesBelgium
- Study dates
- Oct 2013to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- unilateral hip arthritis or avascular necrosis (AVN) in need for total hip replacement
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites, 2 recruiting
- Recruiting
UZA
Antwerp, Antwerp, 2000
Claudia Hendrickx, PhD student, 0032 (0)3 821 32 92, Claudia.Hendrickx@uantwerpen.be
Claudia Hendrickx, Phd Student
- Recruiting
ZNA Middelheim
Wilrijk, Antwerp, 2020
Peter Mertens, MD
About this study
Official title: Percutaneous Assisted Approach for Total Hip Replacement and it's Effect on Functional Rehabilitation Compared to the Anterolateral Approach.
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.
- Conditions
- Total Hip Arthroplasty
- Being tested
- Ceramic on ceramic couple, Percutaneous assisted approach, Anterolateral approach, Usual care
- Keywords
- Total Hip Arthroplasty, Gluteus medius, Approach, Rehabilitation, Functional outcome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ceramic on ceramic coupleProcedure or surgery
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 approachProcedure or surgery
Anterolateral approachProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Ceramic on ceramic couple; Procedure: Percutaneous assisted approach; Other: 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. Receives: Procedure: Ceramic on ceramic couple; Procedure: Anterolateral approach; Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, 4 weeks, 12 weeks
Secondary outcomes (12)
surface electromyography (sEMG) of gluteus medius
sEMG of the gluteus medius is recorded during maximally voluntary isometric contraction and during single leg stance.
Measured: baseline
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.
Measured: baseline, 4 weeks, 12 weeks
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.
Measured: baseline, 4 weeks, 12 weeks
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
Measured: baseline
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).
Measured: baseline, 4 weeks, 12 weeks
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.
Measured: baseline, 4 weeks, 6 weeks
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.
Measured: baseline, 4 weeks, 12 weeks
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.
Measured: baseline, 4 weeks, 12 weeks
surface electromyography (sEMG) of gluteus medius
sEMG of the gluteus medius is recorded during maximally voluntary isometric contraction and during single leg stance.
Measured: 4 weeks
surface electromyography (sEMG) of gluteus medius
sEMG of the gluteus medius is recorded during maximally voluntary isometric contraction and during single leg stance.
Measured: 12 weeks
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
Measured: 4 weeks
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
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2014 (estimated)
- Study startOct 2013
- Primary completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Total Hip ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiteit Antwerpen
- Sponsor type
- University, hospital or other
- Collaborators
- Stöpler Belgium nv
- Responsible party
- Principal investigator, Claudia Hendrickx, Universiteit Antwerpen
- Investigators
- Claudia Hendrickx, PhD student, Principal investigator, Universiteit Antwerpen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02032017
- Sponsor's protocol ID
- B300201318915
- Status last verified
- Jan 2014
- First submitted
- 7 Jan 2014
- Last updated
- 9 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25298243
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Assisted Approach for Total Hip Replacement and it's Effect on Functional Rehabilitation Compared to the Anterolateral Approach.
- ClinicalTrials.gov ID
- NCT02032017
- Acronym / sponsor ID
- B300201318915
- Conditions
- Total Hip Arthroplasty
- Keywords
- Total Hip Arthroplasty, Gluteus medius, Approach, Rehabilitation, Functional outcome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universiteit AntwerpenUniversity, hospital or other
- Collaborators
- Stöpler Belgium nv
- Study start
- Oct 2013
- Primary completion
- Dec 2014 (estimated)
- First posted
- 9 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Percutaneous assisted approach | Experimental | Procedure: Ceramic on ceramic couple, Procedure: Percutaneous assisted approach, Other: Usual careIn 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. |
| Anterolateral approach | Active comparator | Procedure: Ceramic on ceramic couple, Procedure: Anterolateral approach, Other: Usual careA standard transgluteal approach is used. This means a large part of the gluteus medius muscle is released to obtain good access to the acetabulum. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- unilateral hip arthritis or avascular necrosis (AVN) in need for total hip replacement
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ceramic on ceramic coupleAll 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. | Procedure or surgery | Anterolateral approach, Percutaneous assisted approach |
| Percutaneous assisted approach | Procedure or surgery | Percutaneous assisted approach |
| Anterolateral approach | Procedure or surgery | Anterolateral approach |
| Usual careBoth 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. | Other | Anterolateral approach, Percutaneous assisted approach |
Primary outcome
change in time needed for the timed get up and go test
Time frame: baseline, 4 weeks, 12 weeks
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.
12 secondary outcomes
surface electromyography (sEMG) of gluteus medius
Time frame: baseline
Change in hip abductor muscle strength measured by MicroFET 2
Time frame: baseline, 4 weeks, 12 weeks
Change in knee extensor muscle strength measured by MicroFET 2
Time frame: baseline, 4 weeks, 12 weeks
Score on the Trendelenburg test
Time frame: baseline
Change in score on the Oxford Hip Score
Time frame: baseline, 4 weeks, 12 weeks
Change in score on the SF-36 and it's subscales
Time frame: baseline, 4 weeks, 6 weeks
Change in time needed to complete the 5 times sit-to-stand test
Time frame: baseline, 4 weeks, 12 weeks
Change in distance walked during the 6 minute walking test
Time frame: baseline, 4 weeks, 12 weeks
surface electromyography (sEMG) of gluteus medius
Time frame: 4 weeks
surface electromyography (sEMG) of gluteus medius
Time frame: 12 weeks
Score on the trendelenburg test
Time frame: 4 weeks
Score on the Trendelenburg test
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2014.
- Derived from this study: PubMed 25298243Hendrickx 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.
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Developmental Dysplasia of the Hip, Acetabular Bone Loss
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Effects of Combined Pericapsular Nerve Group (PENG) and Lateral Femoral Cutaneous Nerve (LFCN) Blocks on Anaesthetic Requirements and Electroencephalographic Depth of Anaesthesia During Total Hip Arthroplasty: A Randomized Controlled Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia Hendrickx, PhD student principal investigator
Universiteit Antwerpen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ceramic on ceramic couple, Percutaneous assisted approach and Anterolateral approach in people with Total Hip Arthroplasty, run by Universiteit Antwerpen at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Claudia Hendrickx, PhD student (0032 (0)3 821 32 92, Claudia.Hendrickx@uantwerpen.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in time needed for the timed get up and go test (time frame: baseline, 4 weeks, 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02032017, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2014.