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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

July 7, 2009
March 7, 2013
July 2003
December 2008   (final data collection date for 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 ] [ Designated as safety issue: Yes ]
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: Routine follow-up visits were scheduled for six weeks, three, six, nine, twelve months, and yearly thereafter ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00936949 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Posterolateral Surgical Approach Compared With Modified Lateral Approach
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Arthroplasty, Replacement, Hip
  • 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
  • Procedure: modified lateral approach
    The operative technique described modified lateral approach as described by Mulliken et al.
    Other Name: modified lateral approach
  • 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.
    Intervention: Procedure: surgical approach
  • Active Comparator: modified lateral approach
    The operative technique described modified lateral approach as described by Mulliken et al.
    Intervention: Procedure: modified lateral approach
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
196
December 2008
December 2008   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00936949
SNU 03-01
Yes
Kyung-Hoi, Koo professor, Seoul national University Bundang Hospital
Seoul National University Bundang Hospital
Not Provided
Principal Investigator: Kyung-Hoi Koo, professor Seoul National University Bundang Hospital
Seoul National University Bundang Hospital
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP