NCT00936949

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
196

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 7, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 10, 2009

Completed
Last Updated

March 8, 2013

Status Verified

July 1, 2009

Enrollment Period

5.4 years

First QC Date

July 7, 2009

Last Update Submit

March 7, 2013

Conditions

Keywords

total hip arthroplastyposterolateralmodified lateral

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • 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

Study Arms (2)

posterolateral approach

ACTIVE COMPARATOR

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

modified lateral approach

ACTIVE COMPARATOR

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

Procedure: modified lateral approach

Interventions

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.

Also known as: posterolateral approach
posterolateral approach

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

modified lateral approach

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • osteonecrosis
  • primary or secondary osteoarthritis of the hips
  • femoral neck fracture.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul national University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

Study Officials

  • Kyung-Hoi Koo, professor

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 7, 2009

First Posted

July 10, 2009

Study Start

July 1, 2003

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

March 8, 2013

Record last verified: 2009-07

Locations