CoxarthrosisPhase 4NCT01578746
Comparison Between Anterior and Direct Lateral Approach in Total Hip Arthroplasty
A Phase 4 study testing Direct lateral approach in total hip arthroplasty and Anterior approach in people with Coxarthrosis, run by Sorlandet Hospital HF at 1 site in Norway.
Trial summary
In total hip arthroplasty several approaches can be used. The newly introduced minimally invasive anterior approach is supposed to cause less damage to tendons and muscles. At the same time there are reports that there are more complications when this approach is used. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Coxarthrosis
- What is being tested?
- Direct lateral approach in total hip arthroplasty and Anterior approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2012to Dec 2016
- Phase
- Phase 4
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical and radiological diagnosis of coxarthrosis
Who cannot join
- Previous surgery on affected hip
- No mental disability preventing follow-up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Minimally Invasive Anterior Approach and Direct Lateral Approach in Total Hip Arthroplasty - A Prospective Randomized Trial
In total hip arthroplasty several approaches can be used. The newly introduced minimally invasive anterior approach is supposed to cause less damage to tendons and muscles. At the same time there are reports that there are more complications when this approach is used. The direct lateral approach is the most used in Norway and is well documented. There are however those who postulate that there is to high risk of damage to the gluteus medius causing Trendelenburg gait. In the investigators hospital both the anterior and direct lateral approach is used with good result. The investigators main study hypothesis is that there is no difference between the use of anterior or direct lateral approach i total hip arthroplasty in regards to postoperative function and pain, complications, radiological finds (X-ray and MRI), markers for muscle damage (i.e CK-total) or other clinical outcomes.
- Conditions
- Coxarthrosis
- Being tested
- Direct lateral approach in total hip arthroplasty, Anterior approach
- Keywords
- Coxarthrosis, Hip arthroplasty, Anterior approach, Direct lateral approach, Hardinge approach, Smith-Petersen approach, Osteoarthrosis
- Medical subject headings
- Osteoarthritis, Hip, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct lateral approach in total hip arthroplastyProcedure or surgery
Also called Hardinge approach
The use of direct lateral approach in total hip arthroplasty
Anterior approachProcedure or surgery
Also called Smith-Petersen approach
The use of anterior approach in total hip arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| Direct lateral approach | Active comparator | Patient operated using direct lateral approach. Receives: Procedure: Direct lateral approach in total hip arthroplasty |
| Anterior approach | Active comparator | Patient operated using anterior approach. Receives: Procedure: Anterior approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in function
Function of the operated hip will be evaluated after 3, 6, 12 and 24 months using Oxford Hip Score, Harris Hip Score and 6-minute-walk-test. Improvement in general health will be evaluated by using Eq-5D.
Measured: 2 years
Secondary outcomes (4)
Muscle damage
CK-total is measured direct postoperativly and for the next four consequtive days. CRP is measured the first four postoperative days.
Measured: Day of operation and next four consecutive days
Pain
Pain using Visual Analog Scale and the use of analgetics (converted to opioid equivalent doses) are recorded.
Measured: First four postoperative days
X-ray assessment
Placement of the acetabular component (inclination and version) and femoral stem (varus/valgus) and migration.
Measured: 3 and 12 months
MRI
A subselection of about 40 patients will undergo MRI-scans preoperatively and after 3 and 12 months to assess tendon- and muscledamage.
Measured: 3 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2012 (estimated)
- Study startJan 2012
- Primary completionDec 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 CoxarthrosisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sorlandet Hospital HF
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Svein Andreas Svenningsen, M.D, Ph.D, Principal investigator, Sorlandet Hospital HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01578746
- Sponsor's protocol ID
- 811398
- Other IDs
- 2011/2581 D
- Status last verified
- Jun 2013
- First submitted
- 13 Mar 2012
- Last updated
- 14 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Minimally Invasive Anterior Approach and Direct Lateral Approach in Total Hip Arthroplasty - A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT01578746
- Acronym / sponsor ID
- 811398
- Conditions
- Coxarthrosis
- Keywords
- Coxarthrosis, Hip arthroplasty, Anterior approach, Direct lateral approach, Hardinge approach, Smith-Petersen approach, Osteoarthrosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Sorlandet Hospital HFOther government
- Study start
- Jan 2012
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 17 Apr 2012 (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.
In total hip arthroplasty several approaches can be used. The newly introduced minimally invasive anterior approach is supposed to cause less damage to tendons and muscles. At the same time there are reports that there are more complications when this approach is used. The direct lateral approach is the most used in Norway and is well documented. There are however those who postulate that there is to high risk of damage to the gluteus medius causing Trendelenburg gait. In the investigators hospital both the anterior and direct lateral approach is used with good result. The investigators main study hypothesis is that there is no difference between the use of anterior or direct lateral approach i total hip arthroplasty in regards to postoperative function and pain, complications, radiological finds (X-ray and MRI), markers for muscle damage (i.e CK-total) or other clinical outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Direct lateral approach | Active comparator | Procedure: Direct lateral approach in total hip arthroplastyPatient operated using direct lateral approach. |
| Anterior approach | Active comparator | Procedure: Anterior approachPatient operated using anterior approach. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical and radiological diagnosis of coxarthrosis
Key exclusion criteria (2 listed)
- Previous surgery on affected hip
- No mental disability preventing follow-up
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 |
|---|---|---|
| Direct lateral approach in total hip arthroplastyAlso: Hardinge approachThe use of direct lateral approach in total hip arthroplasty | Procedure or surgery | Direct lateral approach |
| Anterior approachAlso: Smith-Petersen approachThe use of anterior approach in total hip arthroplasty | Procedure or surgery | Anterior approach |
Primary outcome
Change in function
Time frame: 2 years
Function of the operated hip will be evaluated after 3, 6, 12 and 24 months using Oxford Hip Score, Harris Hip Score and 6-minute-walk-test. Improvement in general health will be evaluated by using Eq-5D.
4 secondary outcomes
Muscle damage
Time frame: Day of operation and next four consecutive days
Pain
Time frame: First four postoperative days
X-ray assessment
Time frame: 3 and 12 months
MRI
Time frame: 3 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2013.
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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.
Svein Andreas Svenningsen, M.D, Ph.D principal investigator
Sorlandet Hospital HF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Direct lateral approach in total hip arthroplasty and Anterior approach in people with Coxarthrosis, run by Sorlandet Hospital HF at 1 site in Norway.
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 2 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 14 Jun 2013. 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 Norway. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in function (time frame: 2 years). 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 14 Jun 2013.