Compaction Total Hip Arthroplasty (THA) Unilateral

This study is ongoing, but not recruiting participants.

First Received: April 23, 2006 Last Updated: October 26, 2007 History of Changes

Sponsored by:	Northern Orthopaedic Division, Denmark
Information provided by:	Northern Orthopaedic Division, Denmark
ClinicalTrials.gov Identifier:	NCT00318396

Purpose

This is a prospective, randomized study comparing two different bone preparation techniques for insertion of a hydroxylapatite (HA) coated titanium cementless femoral stem. Patients receiving a unilateral total hip replacement are randomized to either conventional broaching or compaction.

Hypothesis: Compaction results in significantly less stem migration [evaluated by radiostereometric analysis (RSA)], less peri-prosthetic bone mineral density (BMD) loss [evaluated by dual energy x-ray absorptiometry (DEXA)], and a higher Harris hip score after two years.

Condition	Intervention
Coxarthrosis	Procedure: Bone preparation technique: compaction Procedure: Bone preparation technique: broaching

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Compaction THA Uni-Lateral

Further study details as provided by Northern Orthopaedic Division, Denmark:

Estimated Enrollment:	40
Estimated Study Completion Date:	December 2009

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with primary arthritis in the hip
Patients with sufficient bone density to allow uncemented implantation of a femoral component
Informed patient consent in writing

Exclusion Criteria:

Patients with neuromuscular or vascular disease in the affected leg
Patients found upon operation to be unsuited for uncemented acetabulum component
Patients who regularly take non-steroidal anti-inflammatory drugs (NSAIDs) and cannot interrupt intake for the postoperative phase of the study
Patients with fracture sequelae
Female patients of childbearing capacity
Hip joint dysplasia
Sequelae to previous hip joint disorder in childhood

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00318396

Locations

Denmark, Northern Jutland
Northern Orthopaedic Division, Klinik Farsoe and Aarhus University Hospital
Farsoe, Northern Jutland, Denmark

Sponsors and Collaborators

Northern Orthopaedic Division, Denmark

Investigators

Principal Investigator:	Søren Kold, MD	Northern Orthopaedic Division
Study Director:	Kjeld Søballe, MD, Prof.	University og Aarhus

More Information

No publications provided

Study ID Numbers:	ON-04-002a-SKO
Study First Received:	April 23, 2006
Last Updated:	October 26, 2007
ClinicalTrials.gov Identifier:	NCT00318396 History of Changes
Health Authority:	Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by Northern Orthopaedic Division, Denmark:

THA

Study placed in the following topic categories:

Musculoskeletal Diseases
Osteoarthritis
Joint Diseases

Arthritis
Rheumatic Diseases
Osteoarthritis, Hip

Additional relevant MeSH terms:

Musculoskeletal Diseases
Osteoarthritis
Joint Diseases

Arthritis
Rheumatic Diseases
Osteoarthritis, Hip

ClinicalTrials.gov processed this record on May 06, 2009