Posterolateral Surgical Approach Compared With Modified Lateral Approach

Arthroplasty, Replacement, Hip Clinical Trial

Official title:

Posterolateral Surgical Approach Compared With Modified Lateral Approach: A Prospective, Randomised Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00936949
• Other study ID #: SNU 03-01
• Status: Completed
• Phase: N/A
• First received: July 7, 2009
• Last updated: March 7, 2013
• Start date: July 2003
• Est. completion date: December 2008

Study information

• Verified date: July 2009
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 196
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Hip

Intervention

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.
• modified lateral approach
The operative technique described modified lateral approach as described by Mulliken et al.

Locations

Country	Name	City	State
Korea, Republic of	Seoul national University Bundang Hospital	Seongnam-Si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes