Clinical trial NCT00936949: Posterolateral Surgical Approach Compared With Modified Lateral Approach
Official title: Posterolateral Surgical Approach Compared With Modified Lateral Approach: A Prospective, Randomised Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthroplasty, Replacement, Hip
Keywords: total hip arthroplasty
posterolateral
modified lateral
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2009-07-10
Enrollment: 196
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
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
timeFrame: up to 2 years
Secondary outcomes:
measure: 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.
timeFrame: Routine follow-up visits were scheduled for six weeks, three, six, nine, twelve months, and yearly thereafter
Other outcomes:
Locations:
city: Seongnam-Si
country: Korea, Republic of
facility: Seoul national University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Kyung-Hoi Koo, professor
role: PRINCIPAL_INVESTIGATOR
References: