A Migration and Bone Density Study Comparing Hi-Fatigue Bone Cement and Palacos Bone Cement

University of Aarhus

Status

Completed

Conditions

Hip Arthritis

Treatments

Device: Palacos Bone Cement

Device: Hi-Fatigue Bone Cement

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01289834

VEK20100112

Details and patient eligibility

About

The purpose of this scientific study is to compare early migration of hip prostheses in respect to the bone in order to determine whether there is a clinical difference between the two investigated bone cements (which one is best suited for cementation of hip prostheses).

Full description

A randomized controlled clinical trial on 50 hybrid hips age above 70 years to the described two surgical procedures will be performed at Aarhus University hospital by two orthopaedic consultants. Randomization in 10 blocks of ten patients distributed with five patients for Palacos Cement and five patients for Hi-Fatigue Cement.

25 CPT femoral stems fixed with Hi-Fatigue Bone Cement.
25 CPT femoral stems fixed with Palacos Bone Cement.

All patients will be operated by the postero-lateral approach. The post-operative treatment and training will not differ from the standard.

Enrollment

52 patients

Sex

All

Ages

71+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

primary hip osteoarthritis
sufficient bone quality for total hip arthroplasty
age 71 years and above
no upper age limit if the patient is capable
informed and written consent
patient can only enter the project with one hip

Exclusion criteria

planned bilateral hip surgery
neuromuscular or vascular disease in the affected leg
preoperatively not found suitable for a hip arthroplasty
patients with osteoporosis based on former diagnosis or preoperative DEXA-scan
fracture sequelae, osteonecrosis or previous extensive hip surgery
patients who cannot refrain from taking NSAID post-operatively
continuous medical treatment with vitamin K antagonists (Warfarin) which is known to reduce the bone mass by a factor of 5
patients with metabolic bone disease
patients with rheumatoid arthritis
postmenopausal women in systemic estrogenic hormone substitution
patients with a continuous need of systemic cortisone treatment
non-Danish citizenship
patients who do not comprehend the Danish language (read and speak)
senile dementia
alcoholism - defined as men drinking more than 21 units a week and women drinking more than 14 units a week
drug abuse
major psychiatric disease
metastatic cancer disease and treatment with radiation therapy or chemotherapy
severe systemic disease (e.g. hemi paresis and Parkinson disease)
systemic hip and spine disease
employee at the orthopaedic department, Aarhus University Hospital
ongoing case regarding industrial injury insurance of the knee
patients with poor dental status (risk of infection)