Clinical trial NCT00119977: Periacetabular Osteotomy.A Prospective Study With Reference to Cartilage, Migration and Bone Density
Official title: Periacetabular Osteotomy. A Prospective Study With Reference to Cartilage, Migration and Bone Density
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Keywords: cartilage thickness
RSA
DEXA
ultra sound
MRI
osteoarthritis
periacetabular osteotomy
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2005-07-14
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effect of performing a periacetabular osteotomy on patients with hip dysplasia.

Detailed description: The cause of osteoarthritis in hip dysplasia is thought to be attributable to increased joint contact pressures secondary to decreased acetabular coverage of the femoral head and/or incongruity of the articular surfaces. The investigators' hypothesis is that when periacetabular osteotomy is performed and contact pressure on cartilage reduced, additional joint degeneration will be slowed or prevented unless irreparable damage to the cartilage has happened at the time periacetabular osteotomy is performed. Hence, the purposes of this study are:

* to develop an unbiased and precise method for measurement of the thickness of the articular cartilage in the hip joint because such a method can be used to evaluate the effect of periacetabular osteotomy and also to give a more precise indication/contraindication for surgery;
* to evaluate the migration of the acetabulum postoperatively and 6 months after surgery by use of RSA to examine the stability of the osteotomy; and
* to examine bone mineral density in acetabulum 1 and 2 years after surgery in order to find out whether the change in load distribution will affect bone density of the acetabulum over time in a way that in the area where more load is applied, bone density will increase, and in areas with less load, bone density will decrease;
* to examine the labrum in the hip joint.

Eligibility criteria: Inclusion Criteria:

* Patients with radiologically diagnosed hip dysplasia (CE-angle \< 25°)
* Patients with osteoarthritis graded 0, 1 or 2 defined according to Tönnis' classification
* Patients with pain from hip
* Age \> 18 years
* Minimum 110° flexion in hip joint and closed growth zones in the pelvic region
* Informed consent

Exclusion Criteria:

* Patients with neurological diseases
* Patients with calvé-Legg-Perthes syndrome
* Patients where a femoral intertrochanteric osteotomy is necessary
* Patients with medical sequelae after earlier hip surgery
* Females who are pregnant
* Patients with metal implants

Primary outcomes:
measure: migration of acetabulum
timeFrame: six months
Secondary outcomes:
measure: BMD in acetabulum
timeFrame: within two and a half year
measure: status of labrum
timeFrame: three years after pelvic osteotomy
measure: changes in cartilage thickness
timeFrame: two and half a year
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Orthopaedic Center, Aarhus University Hospital
Study officials:
affiliation: Orthopaedic Center, Aarhus University Hospital, Aarhus Denmark
name: Kjeld Søballe, MD Professor
role: PRINCIPAL_INVESTIGATOR
References: