Posterolateral Surgical Approach Compared With Modified Lateral Approach

This study has been completed.
Sponsor:
Information provided by:
Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT00936949
First received: July 7, 2009
Last updated: March 7, 2013
Last verified: July 2009
  Purpose

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.


Condition Intervention
Arthroplasty, Replacement, Hip
Procedure: surgical approach
Procedure: modified lateral approach

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Posterolateral Surgical Approach Compared With Modified Lateral Approach: A Prospective, Randomised Trial

Resource links provided by NLM:


Further study details as provided by Seoul National University Bundang Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 196
Study Start Date: July 2003
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Procedure: surgical 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.
Other Name: posterolateral approach
Active Comparator: modified lateral approach
The operative technique described modified lateral approach as described by Mulliken et al.
Procedure: modified lateral approach
The operative technique described modified lateral approach as described by Mulliken et al.
Other Name: modified lateral approach

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00936949

Locations
Korea, Republic of
Seoul national University Bundang Hospital
Seongnam-Si, Gyeonggi-do, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Bundang Hospital
Investigators
Principal Investigator: Kyung-Hoi Koo, professor Seoul National University Bundang Hospital
  More Information

No publications provided

Responsible Party: Kyung-Hoi, Koo professor, Seoul national University Bundang Hospital
ClinicalTrials.gov Identifier: NCT00936949     History of Changes
Other Study ID Numbers: SNU 03-01
Study First Received: July 7, 2009
Last Updated: March 7, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Bundang Hospital:
total hip arthroplasty
posterolateral
modified lateral

ClinicalTrials.gov processed this record on July 23, 2014