CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 112 enrolled
Drug / intervention
direct anterior approach +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02719236
NCT02719236N/ACompleted

Direct Anterior Approach Versus Direct Lateral Approach in Cementless Total Hip Arthroplasty

Iuliu Hatieganu University of Medicine and Pharmacy·interventional·Posted Mar 25, 2016·Updated Feb 10, 2021

In Brief

A clinical study evaluating direct anterior approach and direct lateral approach for Coxarthrosis. Completed, enrolled 112 participants across 1 site.

Detailed Summary

The purpose of this study is to compare the direct anterior approach and the direct lateral approach in primary total hip arthroplasty, regarding the postoperative function and pain, complications, radiological finds (X-ray), postoperative hemorrhage, markers for muscle damage (i.e creatine kinase (CK), lactate dehydrogenase(LDH/LD) , aspartate aminotransferase(AST), C-reactive protein (CRP),Troponin and Myoglobin) or other clinical outcomes.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCoxarthrosis
CountriesRomania

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 25, 2016
Enrollment StartMar 1, 2015
Primary CompletionFeb 1, 2020
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 10.3 years ago

Interventions

direct anterior approachprocedure

The procedure begins by positioning the patient supine on a normal table . Both feet are draped separately to assist with dislocating and proximal femural shaft exposure.The surgical incision begins 2-4 cm lateral to the anterior superior iliac spine of the pelvis . It is then carried distally and laterally for about 8-12 cm. After protecting the lateral femoral cutaneous nerve, the fascia overlying the tensor fascia latae (TFL) is incised, and a plane is then developed between the TFL and sartorius. After coagulating the ascending branch of the lateral femoral circumflex artery, a capsulectomy is performed. Placement of the final acetabular component is facilitated by the use of an offset inserter handle. Femoral preparation begins by placing the operative limb in a position of extension, adduction and external rotation to improve the accessibility of the proximal femur. Once the final implants are in situ, the hip is reduced and assessed.

direct lateral approachprocedure

The procedure begins by positioning the patient in the supine decubitus position. A longitudinal incision is made extending 3-5 cm proximal and about 5-8 cm distal to the tip of the greater trochanter . The fascia is split at the interval between the TFL and gluteus. The tendon and muscle fibres of the gluteus medius are then visualized and split . The gluteus minimus and joint capsule are split. The surgeon then dislocates the femoral head, and performs a femoral neck osteotomy. The acetabulum is prepared .Soft tissue landmarks and reamer positioning relative to the floor are used to verify acetabular version and inclination. When preparing the proximal femur, the hip is adducted and externally rotated, with the knee flexed. The femural stem is then press-fitted. Once the final implants are in situ and the hip is reduced, the stability of the construct is assessed.