Hip Arthritis Clinical Trial
Official title:
A Migration (RSA) and Bone Density (DEXA) Study Comparing Hi-Fatigue Bone Cement and Palacos Bone Cement in Fixation of a Smooth vs. a Fine-blasted Femoral Stem. A Prospective Randomized Study on Primary Total Hip Arthroplasty.
NCT number | NCT01289834 |
Other study ID # | VEK20100112 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 2010 |
Est. completion date | January 2024 |
Verified date | April 2024 |
Source | University of Aarhus |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 52 |
Est. completion date | January 2024 |
Est. primary completion date | April 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 71 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Denmark | Kjeld Soballe, Orthopaedic center, University of Aarhus | Aarhus |
Lead Sponsor | Collaborator |
---|---|
University of Aarhus | Aarhus University Hospital, Zimmer Biomet |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Femoral component migration (roentgen stereo photogrammetric analysis - RSA) | Migration of the femoral component is measured over time and in respect to the femur bone. | 2 years |
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