Posterolateral Surgical Approach Compared With Modified Lateral Approach

Tracking Information
First Submitted Date ICMJE	July 7, 2009
First Posted Date ICMJE	July 10, 2009
Last Update Posted Date	March 8, 2013
Study Start Date ICMJE	July 2003
Actual Primary Completion Date	December 2008 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: March 7, 2013)	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 ]
Original Primary Outcome Measures ICMJE; (submitted: July 8, 2009)	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 ]
Change History	Complete list of historical versions of study NCT00936949 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: July 8, 2009)	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 ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Posterolateral Surgical Approach Compared With Modified Lateral Approach
Official Title ICMJE	Posterolateral Surgical Approach Compared With Modified Lateral Approach: A Prospective, Randomised Trial
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.
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment
Condition ICMJE	Arthroplasty, Replacement, Hip
Intervention ICMJE	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.
Study Arms	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: July 8, 2009)	196
Original Actual Enrollment ICMJE	Same as current
Actual Study Completion Date	December 2008
Actual Primary Completion Date	December 2008 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	Child, Adult, Senior
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Korea, Republic of
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00936949
Other Study ID Numbers ICMJE	SNU 03-01
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Kyung-Hoi, Koo professor, Seoul national University Bundang Hospital
Study Sponsor ICMJE	Seoul National University Bundang Hospital
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Kyung-Hoi Koo, professor Seoul National University Bundang Hospital
PRS Account	Seoul National University Bundang Hospital
Verification Date	July 2009
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP