Osteoarthritis of the HipNCT02458144
Comparison of MIS Anterior Versus MIS Anterolateral Approach
A study testing Total hip arthroplasty in people with Osteoarthritis of the Hip, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Aim of the present investigation is to analyse the amount of muscle trauma in relation to the surgical approach and to the individual postoperative functional recovery. The investigation will compare the MIS (minimally invasive surgery) anterior approach with the MIS anterolateral approach to the hip. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Osteoarthritis of the Hip
- What is being tested?
- Total hip arthroplasty
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteAustria
- Study dates
- Jan 2013to Dec 2016
- 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, noninflammatory end-stage osteoarthritis of the hip
- willingness and ability to cooperate in the required post-operative therapy
- willingness and ability to provide written informed consent
- age 50-80 years
Who cannot join
- inflammatory arthropathies
- prior hip surgery
- prior infection of the hip
- severe morbidity
- severe osteoporosis
- inability to tolerate general anesthesia
Show all 10Show fewer
- no contraindications to MRI e.g. pacemakers, claustrophobia
- neuromuscular disorder, vascular disorder or other conditions that could contribute to prosthesis instability, prosthesis fixation failure, or complications in postoperative care
- known alcohol or drug abuse
- unwillingness to participate
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Department of Orthopaedics
Vienna, State of Vienna, 1090
Christoph Stihsen, Registrar, 0140400 ext. 40820, christoph.stihsen@meduniwien.ac.at
Bernd Kubista, Consultant, 0140400 ext. 40820, bernd.kubista@meduniwien.ac.at
About this study
Official title: Comparison of Two Minimally Invasive Approaches to the Hip-anterior Versus Anterolateral - Which Technique is Less Invasive? A Prospective, Randomized, Controlled Pilot Study
Aim of the present investigation is to analyse the amount of muscle trauma in relation to the surgical approach and to the individual postoperative functional recovery. The investigation will compare the MIS (minimally invasive surgery) anterior approach with the MIS anterolateral approach to the hip.
Read the detailed description
The surgical approach to the hip is reportedly an important factor influencing implant stability and postsurgical muscle functioning. Reviewing the literature, controversial studies towards minimally invasive hip surgery can be found. Currently, none of the approaches can be considered superior, but the trend is towards minimally invasive techniques, as it is generally accepted that muscle trauma and damage of the periarticular structures should be minimized. However, a surgical approach that causes no damage to surrounding muscle is unrealistic. Whether the muscle is stretched, transacted or partially torn, injury will occur.
Aim of the present investigation is to analyse the amount of muscle trauma in relation to the surgical approach and to the individual postoperative functional recovery. The investigation will compare the MIS anterior approach with the MIS anterolateral approach to the hip. The investigators questioned, which technique would be the less invasive? Pain and functional performance will be measured using the Harris Hip Score, the Western Ontario McMaster, and the UCLA (University of California) Activity Score. Subject quality-of-life will be determined by evaluation the Short-Form 36 Health Survey. Standard radiographs of the hip are required to be captured before surgery and at 3, 6 and 12 months postoperatively. MRI scans will be performed to evaluate tendon defects, fatty atrophy and changes in the muscle cross-sectional area. Next, the patients will be referred for hip sonography, performed by a radiologist who is experienced in imaging of the musculoskeletal system who will be unaware of the clinical examination results of the patients. Moreover gait analyses will be performed preoperatively, 3 and 12 months after surgery. Pre- and postoperative standard blood tests and specific serum trauma markers will be obtained.
- Conditions
- Osteoarthritis of the Hip
- Being tested
- Total hip arthroplasty
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total hip arthroplastyProcedure or surgery
The minimally invasive anterior approach The patient is in supine position. The femoral neck is exposed in the interval between tensor fasciae latae, glutei medius and minimus muscles laterally, and sartorius and rectus femoris muscles medially. After osteotomy of the neck and extraction of the head the acetabulum is reamed to prepare for cup prosthesis. Following peritrochanteric capsulotomy the externally rotated, adducted and elevated femur is broached.
The MIS anterolateral approach The MIS anterolateral technique is a modified Watson-Jones Approach. The patient is in supine position. This approach uses the intermuscular plane between the gluteus medius and the tensor fascia latae. After the anterior capsule is excised, a disc of the femoral neck is removed.
| Study group | Role | What they receive |
|---|---|---|
| MIS "anterior" group | Other | Total Hip Arthroplasty "anterior" surgical approach Receives: Procedure: Total hip arthroplasty |
| MIS "anterolateral" group | Other | Total Hip Arthroplasty "anterolateral" surgical approach Receives: Procedure: Total hip arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI evaluation
Cross-sectional area of gluteus medius and tensor fascia latae muscle (cm2)
Measured: 12 months after surgery
Secondary outcomes (11)
Harris Hip Score
Points (0-100)
Measured: 12 months after surgery
Tendon defects of the hip abductors (cm) assessed by Ultrasound
Tendon defects of the hip abductors (cm)
Measured: 12 months after surgery
Gait analysis
posture of the pelvis, hip strength, range of motion
Measured: 12 months after surgery
Serum trauma marker 1
creatinkinase (u/l)
Measured: 1 hour preop. to 48 hours postop.
Serum trauma marker 2
interleukin-6 (pg/ml)
Measured: 1 hour preop. to 48 hours postop.
Serum trauma marker 3
interleukin-1β (pg/ml)
Measured: 1 hour preop. to 48 hours postop.
Serum trauma marker 4
lactate Dehydrogenase (u/l)
Measured: 1 hour preop. to 48 hours postop.
Serum trauma marker 5
aldolase (u/l)
Measured: 1 hour preop. to 48 hours postop.
Serum trauma marker 6
Myoglobin (ng/ml)
Measured: 1 hour preop. to 48 hours postop.
Serum trauma marker 7
malondialdehyde (mg/dl)
Measured: 1 hour preop. to 48 hours postop.
Serum trauma marker 8
glutathione (mg/dl)
Measured: 1 hour preop. to 48 hours postop.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2015 (estimated)
- Study startJan 2013
- Primary completionAug 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of the HipStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Christoph Stihsen, Medical University of Vienna
- Investigators
- Reinhard Windhager, Chairman, Study chair, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02458144
- Sponsor's protocol ID
- 1392/2012
- Status last verified
- May 2015
- First submitted
- 26 May 2015
- Last updated
- 29 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Minimally Invasive Approaches to the Hip-anterior Versus Anterolateral - Which Technique is Less Invasive? A Prospective, Randomized, Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT02458144
- Acronym / sponsor ID
- 1392/2012
- Conditions
- Osteoarthritis of the Hip
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 29 May 2015 (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.
Aim of the present investigation is to analyse the amount of muscle trauma in relation to the surgical approach and to the individual postoperative functional recovery. The investigation will compare the MIS (minimally invasive surgery) anterior approach with the MIS anterolateral approach to the hip.
Detailed description
The surgical approach to the hip is reportedly an important factor influencing implant stability and postsurgical muscle functioning. Reviewing the literature, controversial studies towards minimally invasive hip surgery can be found. Currently, none of the approaches can be considered superior, but the trend is towards minimally invasive techniques, as it is generally accepted that muscle trauma and damage of the periarticular structures should be minimized. However, a surgical approach that causes no damage to surrounding muscle is unrealistic. Whether the muscle is stretched, transacted or partially torn, injury will occur.
Aim of the present investigation is to analyse the amount of muscle trauma in relation to the surgical approach and to the individual postoperative functional recovery. The investigation will compare the MIS anterior approach with the MIS anterolateral approach to the hip. The investigators questioned, which technique would be the less invasive? Pain and functional performance will be measured using the Harris Hip Score, the Western Ontario McMaster, and the UCLA (University of California) Activity Score. Subject quality-of-life will be determined by evaluation the Short-Form 36 Health Survey. Standard radiographs of the hip are required to be captured before surgery and at 3, 6 and 12 months postoperatively. MRI scans will be performed to evaluate tendon defects, fatty atrophy and changes in the muscle cross-sectional area. Next, the patients will be referred for hip sonography, performed by a radiologist who is experienced in imaging of the musculoskeletal system who will be unaware of the clinical examination results of the patients. Moreover gait analyses will be performed preoperatively, 3 and 12 months after surgery. Pre- and postoperative standard blood tests and specific serum trauma markers will be obtained.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MIS "anterior" group | Other | Procedure: Total hip arthroplastyTotal Hip Arthroplasty "anterior" surgical approach |
| MIS "anterolateral" group | Other | Procedure: Total hip arthroplastyTotal Hip Arthroplasty "anterolateral" surgical approach |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- unilateral, noninflammatory end-stage osteoarthritis of the hip
- willingness and ability to cooperate in the required post-operative therapy
- willingness and ability to provide written informed consent
- age 50-80 years
Key exclusion criteria (10 listed)
- inflammatory arthropathies
- prior hip surgery
- prior infection of the hip
- severe morbidity
- severe osteoporosis
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 |
|---|---|---|
| Total hip arthroplastyThe minimally invasive anterior approach The patient is in supine position. The femoral neck is exposed in the interval between tensor fasciae latae, glutei medius and minimus muscles laterally, and sartorius and rectus femoris muscles medially. After osteotomy of the neck and extraction of the head the acetabulum is reamed to prepare for cup prosthesis. Following peritrochanteric capsulotomy the externally rotated, adducted and elevated femur is broached. The MIS anterolateral approach The MIS anterolateral technique is a modified Watson-Jones Approach. The patient is in supine position. This approach uses the intermuscular plane between the gluteus medius and the tensor fascia latae. After the anterior capsule is excised, a disc of the femoral neck is removed. | Procedure or surgery | MIS "anterior" group, MIS "anterolateral" group |
Primary outcome
MRI evaluation
Time frame: 12 months after surgery
Cross-sectional area of gluteus medius and tensor fascia latae muscle (cm2)
11 secondary outcomes
Harris Hip Score
Time frame: 12 months after surgery
Tendon defects of the hip abductors (cm) assessed by Ultrasound
Time frame: 12 months after surgery
Gait analysis
Time frame: 12 months after surgery
Serum trauma marker 1
Time frame: 1 hour preop. to 48 hours postop.
Serum trauma marker 2
Time frame: 1 hour preop. to 48 hours postop.
Serum trauma marker 3
Time frame: 1 hour preop. to 48 hours postop.
Serum trauma marker 4
Time frame: 1 hour preop. to 48 hours postop.
Serum trauma marker 5
Time frame: 1 hour preop. to 48 hours postop.
Serum trauma marker 6
Time frame: 1 hour preop. to 48 hours postop.
Serum trauma marker 7
Time frame: 1 hour preop. to 48 hours postop.
Serum trauma marker 8
Time frame: 1 hour preop. to 48 hours postop.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2015.
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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.
Reinhard Windhager, Chairman study chair
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total hip arthroplasty in people with Osteoarthritis of the Hip, run by Medical University of Vienna at 1 site in Austria.
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 4 inclusion and 10 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 29 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. 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 Christoph Stihsen, Registrar (00431 40400 ext. 40820, christoph.stihsen@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRI evaluation (time frame: 12 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 May 2015.