Posterolateral Surgical Approach Compared With Modified Lateral Approach
1 other identifier
interventional
196
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2003
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 7, 2009
CompletedFirst Posted
Study publicly available on registry
July 10, 2009
CompletedMarch 8, 2013
July 1, 2009
5.4 years
July 7, 2009
March 7, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
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.
Routine follow-up visits were scheduled for six weeks, three, six, nine, twelve months, and yearly thereafter
Study Arms (2)
posterolateral approach
ACTIVE COMPARATORThe 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 COMPARATORThe operative technique described modified lateral approach as described by Mulliken et al.
Interventions
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.
The operative technique described modified lateral approach as described by Mulliken et al.
Eligibility Criteria
You may qualify if:
- osteonecrosis
- primary or secondary osteoarthritis of the hips
- femoral neck fracture.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul national University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707, South Korea
Study Officials
- PRINCIPAL INVESTIGATOR
Kyung-Hoi Koo, professor
Seoul National University Bundang Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 7, 2009
First Posted
July 10, 2009
Study Start
July 1, 2003
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
March 8, 2013
Record last verified: 2009-07