|- candidate number||13128|
|- NTR Number||NTR3520|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||12-jul-2012|
|- Secondary IDs||M010-072 / NL3394609410; METC / CCMO|
|- Public Title||Total hip arthroplasty: Anterior supine intermuscular versus transgluteal approach, a prospective study.|
|- Scientific Title||Total hip arthroplasty: Anterior supine intermuscular versus transgluteal approach, a prospective study.|
|- ACRONYM||ASI study|
|- hypothesis||The hypothesis of this study is patients with a primary total hip arthroplasties through the anterior supine intermuscular approach will show faster improvement in in walking ablility and mobilization in the postoperative period in comparison with those managed with the transgluteal approach.|
|- Healt Condition(s) or Problem(s) studied||Total Hip Arthroplasty|
|- Inclusion criteria||1. Indication THA;|
2. Primairy arthrosis;
3. BMI<30 kg/m;
4. General anesthesia;
5. <80 jaar;
6. ASA-classification I en II.
|- Exclusion criteria||1. Previous surgery of the hip before;|
3. Inflammatory polyarthritis;
4. Local anesthesia;
5. CVA/TIA or MI last half year;
6. ≥ 80 year;
7. ASA-classification III and IV.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jan-2012|
|- planned closingdate||1-jan-2016|
|- Target number of participants||80|
|- Interventions||Total hip arthroplasty through anterior supine intermuscular and transgluteal approach.
Anterior supine intermuscular approach:
Supine position of the patient on the operating table with the possibility of hyperextension in the mid-table in order to facilitate femoral exposure. Anterior incision, 6-9 cm long, starting approximately 2cm lateral and 5 cm distal of the anterior iliac spine. Incision of the fascia, blunt preparation in the intermuscular space between tensor fascia latae muscle and sartorius muscle. Exision of the anterior parts of the capsule. Osteotomy of the femur by hyperextension, adduction and externeal rotation of the leg, incision of the posterior capsule for easy anteriorrization of the femur. Reaming and implantation of the acetabular component. next , the femur was externally rotated and the capsule carefully detached from the greater trochanter. the entrance into the meddulary canal was lifted to achieve unimpaired access for the offset of broaches. a special two-prolonged retractor was inserted between the tendons of the gluteus medius and minimus and the greater trochanter to provide additional leverage. the adducted femur was broached for a cementless stem. since no muscles were split, the fascia between the
Sartorius muscle and tensor muscle was sutered. The subcutaneous fat and skin were sutured.
Surgical technique transgluteal approach:
Supine position of the patient on the operating table. A straight lateral incision is made over the greater trochanter. The iliotibial tract is exposed and divided longitudinally just posterior to the insertion of the tensor fascia lata. The ventral third of vastus lateralis muscle and the gluteal muscle was detached from the bone in one coherent layer using diathermy. The exposed capsule was then opened, and the femoral head was dislocated. Following osteotomy of the femoral neck, the cup was reamed for a cementless cup. For the preparation of the femoral canal, the operated limb was adducted below the contralateral one and rotated outward. The external rotators near the intertrochanteric fossa were tenotomised. While holding back the gluteal muscles, the femur was broached for an uncemented stem. After implantation, the gluteus medius and vastus lateralis was adapted. Then, de fascia latea was closed. The subcutaneous fat and skin were sutured.
|- Primary outcome||Function: Harris Hip Score.|
|- Secondary outcome||Pain, complications, length of incision, blood loss, range of motion, length of hospital stay, complications, radiograph.|
|- Timepoints||2 days, 6 weeks, 3 months, 6 months, 1 year.|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Annelies Bemmel, van|
|- CONTACT for SCIENTIFIC QUERIES|| J.G.A. Amaya|
|- Sponsor/Initiator ||Westfriesgasthuis Hoorn|
(Source(s) of Monetary or Material Support)
|- Brief summary||Background:|
We present the design of a open randomised controlled study of anterior supine intermuscular (ASI) versus transgluteal approach of total hip arthroplasty (THA). The study is designed to evaluate functional outcome after both approaches.
in this randomized controlled trial, 120 consecutive primary noncemented THAs in 120 patients were assigned to one of two groups (ASI or transgluteal). The primary outcome was functional outcome (Harris hip score) at six weeks and one year postoperatively.
By making this design study we wish to contribute to more profound research on the anterior approach of total hip arthroplasty.
|- Main changes (audit trail)|
|- RECORD||12-jul-2012 - 5-aug-2012|