Arthroplasty, Replacement, HipNCT00936949
Posterolateral Surgical Approach Compared With Modified Lateral Approach
A study testing surgical approach and modified lateral approach in people with Arthroplasty, Replacement, Hip, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
It has been reported that the operative approaches have an effect on clinical outcome in total hip arthroplasty. The purpose of this prospective study was to compare clinical and radiological outcomes between anterolateral approach and posterolateral approach in total hip arthroplasty. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Arthroplasty, Replacement, Hip
- What is being tested?
- surgical approach and modified lateral approach
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2003to Dec 2008
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- osteonecrosis
- primary or secondary osteoarthritis of the hips
- femoral neck fracture.
Who cannot join
- Patients with previous hemi- or total hip arthroplasty
- highly dislocated or severe ankylosed hip
- patients who are considered potentially unreliable or who may not reliably attend study visits
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul national University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
About this study
Official title: Posterolateral Surgical Approach Compared With Modified Lateral Approach: A Prospective, Randomised Trial
It has been reported that the operative approaches have an effect on clinical outcome in total hip arthroplasty. The purpose of this prospective study was to compare clinical and radiological outcomes between anterolateral approach and posterolateral approach in total hip arthroplasty.
Read the detailed description
Total hip arthroplasty is one of the most successful orthopaedic procedures for relieving pain and improving quality of life. But dislocation remains the leading early complication after total hip arthroplasty with a reported frequency between 0.4% and 11%. There are several risk factors of dislocation after total hip arthroplasty including patients, implants and surgical approaches. Among lots of risk factors, surgical approach has been debated as one of the important key factor influencing dislocation and abductor function. Direct lateral or posterolateral surgical approach is most commonly used in the total hip arthroplasty. The modified lateral approaches generally are thought to have lower dislocation rates and allow excellent acetabular exposure although limping is increased. The posterolateral approach may allow maintenance of abductor strength but it generally results in a higher dislocation rate. However, there are several reports that the posterolateral approach with capsular repair might be reduced dislocation rate.
We hypothesize the dislocation rate for the posterolateral approach with capsular repair is similar to modified lateral approaches for total hip arthroplasty. A prospective, randomized-controlled study was to examine the null hypothesis that the dislocation rate for the posterior approach with capsular repair was similar to modified lateral approaches for total hip arthroplasty at up to 2 year followup. We attempted to determine whether there was a difference in surgical parameters, component positioning, and clinical results of the modified lateral approach compared with the posterolateral approach.
- Conditions
- Arthroplasty, Replacement, Hip
- Being tested
- surgical approach, modified lateral approach
- Keywords
- total hip arthroplasty, posterolateral, modified lateral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgical approachProcedure or surgery
Also called posterolateral approach
Using a gluteus maximus split, the posterolateral approach remains posterior to the gluteus medius and minimus. Exposure of the hip and proximal femur requires division of the posterior hip capsule and the external rotators. The exposure and dislocation are completed with flexion and internal rotation of the femur. After arthroplasty, the external rotators and posterior capsule was routinely repaired using a heavy absorbable suture.
modified lateral approachProcedure or surgery
The operative technique described modified lateral approach as described by Mulliken et al.
| Study group | Role | What they receive |
|---|---|---|
| posterolateral approach | Active comparator | The posterolateral approach was described by many authors, but all share a common muscular interval in reference to the gluteus medius tendon. Using a gluteus maximus split, the posterolateral approach remains posterior to the gluteus medius and minimus. Exposure of the hip and proximal femur requires division of the posterior hip capsule and the external rotators. The exposure and dislocation are completed with flexion and internal rotation of the femur. After arthroplasty, the external rotators and posterior capsule was routinely repaired using a heavy absorbable suture. Receives: Procedure: surgical approach |
| modified lateral approach | Active comparator | The operative technique described modified lateral approach as described by Mulliken et al. Receives: Procedure: modified lateral approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
to examine the null hypothesis that the dislocation rate for the posterior approach with capsular repair was similar to modified lateral approaches for total hip arthroplasty at up to 2 year followup
Measured: up to 2 years
Secondary outcomes (1)
to determine whether there was a difference in surgical parameters, component positioning, and clinical results of the modified lateral approach compared with the posterolateral approach.
Measured: Routine follow-up visits were scheduled for six weeks, three, six, nine, twelve months, and yearly thereafter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2009 (estimated)
- Study startJul 2003
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty, Replacement, HipStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Kyung-Hoi Koo, professor, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00936949
- Sponsor's protocol ID
- SNU 03-01
- Status last verified
- Jul 2009
- First submitted
- 7 Jul 2009
- Last updated
- 8 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Posterolateral Surgical Approach Compared With Modified Lateral Approach: A Prospective, Randomised Trial
- ClinicalTrials.gov ID
- NCT00936949
- Acronym / sponsor ID
- SNU 03-01
- Conditions
- Arthroplasty, Replacement, Hip
- Keywords
- total hip arthroplasty, posterolateral, modified lateral
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- Jul 2003
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 10 Jul 2009 (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.
It has been reported that the operative approaches have an effect on clinical outcome in total hip arthroplasty. The purpose of this prospective study was to compare clinical and radiological outcomes between anterolateral approach and posterolateral approach in total hip arthroplasty.
Detailed description
Total hip arthroplasty is one of the most successful orthopaedic procedures for relieving pain and improving quality of life. But dislocation remains the leading early complication after total hip arthroplasty with a reported frequency between 0.4% and 11%. There are several risk factors of dislocation after total hip arthroplasty including patients, implants and surgical approaches. Among lots of risk factors, surgical approach has been debated as one of the important key factor influencing dislocation and abductor function. Direct lateral or posterolateral surgical approach is most commonly used in the total hip arthroplasty. The modified lateral approaches generally are thought to have lower dislocation rates and allow excellent acetabular exposure although limping is increased. The posterolateral approach may allow maintenance of abductor strength but it generally results in a higher dislocation rate. However, there are several reports that the posterolateral approach with capsular repair might be reduced dislocation rate.
We hypothesize the dislocation rate for the posterolateral approach with capsular repair is similar to modified lateral approaches for total hip arthroplasty. A prospective, randomized-controlled study was to examine the null hypothesis that the dislocation rate for the posterior approach with capsular repair was similar to modified lateral approaches for total hip arthroplasty at up to 2 year followup. We attempted to determine whether there was a difference in surgical parameters, component positioning, and clinical results of the modified lateral approach compared with the posterolateral approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| posterolateral approach | Active comparator | Procedure: surgical approachThe posterolateral approach was described by many authors, but all share a common muscular interval in reference to the gluteus medius tendon. Using a gluteus maximus split, the posterolateral approach remains posterior to the gluteus medius and minimus. Exposure of the hip and proximal femur requires division of the posterior hip capsule and the external rotators. The exposure and dislocation are completed with flexion and internal rotation of the femur. After arthroplasty, the external rotators and posterior capsule was routinely repaired using a heavy absorbable suture. |
| modified lateral approach | Active comparator | Procedure: modified lateral approachThe operative technique described modified lateral approach as described by Mulliken et al. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- osteonecrosis
- primary or secondary osteoarthritis of the hips
- femoral neck fracture.
Key exclusion criteria (3 listed)
- Patients with previous hemi- or total hip arthroplasty
- highly dislocated or severe ankylosed hip
- patients who are considered potentially unreliable or who may not reliably attend study visits
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 |
|---|---|---|
| surgical approachAlso: posterolateral approachUsing a gluteus maximus split, the posterolateral approach remains posterior to the gluteus medius and minimus. Exposure of the hip and proximal femur requires division of the posterior hip capsule and the external rotators. The exposure and dislocation are completed with flexion and internal rotation of the femur. After arthroplasty, the external rotators and posterior capsule was routinely repaired using a heavy absorbable suture. | Procedure or surgery | posterolateral approach |
| modified lateral approachThe operative technique described modified lateral approach as described by Mulliken et al. | Procedure or surgery | modified lateral approach |
Primary outcome
to examine the null hypothesis that the dislocation rate for the posterior approach with capsular repair was similar to modified lateral approaches for total hip arthroplasty at up to 2 year followup
Time frame: up to 2 years
1 secondary outcome
to determine whether there was a difference in surgical parameters, component positioning, and clinical results of the modified lateral approach compared with the posterolateral approach.
Time frame: Routine follow-up visits were scheduled for six weeks, three, six, nine, twelve months, and yearly thereafter
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 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.
Kyung-Hoi Koo, professor principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing surgical approach and modified lateral approach in people with Arthroplasty, Replacement, Hip, run by Seoul National University Bundang Hospital at 1 site in South Korea.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 8 Mar 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
to examine the null hypothesis that the dislocation rate for the posterior approach with capsular repair was similar to modified lateral approaches for total hip arthroplasty at up to 2 year followup (time frame: up to 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 8 Mar 2013.