Hip Arthritis | A Migration and Bone Density Study Comparing Hi-Fatigue Bone Cement and Palacos Bone Cement
Hip Arthritis research study
What is the primary objective of this study?
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).
Who is eligible to participate?
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)
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Device:Hi-Fatigue Bone Cement
Device:Palacos Bone CementPalacos Bone Cement has been used for 48 years and has a good reputation as the "gold standard" among bone cements (3). It is a high-viscosity cement with rapid application that makes it advantageous for use in orthopedic joint surgery. Palacos cement was developed in order to allow hand mixing of monomers and polymers in a dish in the operating room. Air pollution with toxic monomers in the operating room was a problem that was primarily solved by exhaust ventilation, later supplemented with vacuum mixing
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Hi-Fatigue Bone CementCPT femoral stems fixed with Hi-Fatigue Bone Cement
Palacos Bone CementCPT femoral stems fixed with Palacos Bone Cement
Start Date: August 2010
Completed Date: April 2017
Phase: Phase 2
Primary Outcome: Femoral component migration (roentgen stereo photogrammetric analysis - RSA)
Study sponsors, principal investigator, and references
Principal Investigator: Kjeld Soballe, Professor MD
Lead Sponsor: University of Aarhus
Collaborator: Aarhus University Hospital