- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00936949
Posterolateral Surgical Approach Compared With Modified Lateral Approach
Posterolateral Surgical Approach Compared With Modified Lateral Approach: A Prospective, Randomised Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Gyeonggi-do
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Seongnam-Si, Gyeonggi-do, Korea, Republic of, 463-707
- Seoul National University Bundang Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- osteonecrosis
- primary or secondary osteoarthritis of the hips
- femoral neck fracture.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: posterolateral approach
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.
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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.
Other Names:
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Active Comparator: modified lateral approach
The operative technique described modified lateral approach as described by Mulliken et al.
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The operative technique described modified lateral approach as described by Mulliken et al.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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up to 2 years
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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Routine follow-up visits were scheduled for six weeks, three, six, nine, twelve months, and yearly thereafter
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Collaborators and Investigators
Investigators
- Principal Investigator: Kyung-Hoi Koo, Professor, Seoul National University Bundang Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- SNU 03-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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