This trial is active, not recruiting.

Condition coxarthrosis
Treatments bone preparation technique: compaction, bone preparation technique: conventional technique
Sponsor Northern Orthopaedic Division, Denmark
Start date June 2004
End date December 2015
Trial size 26 participants
Trial identifier NCT00318396, ON-04-002a-SKO


This is a prospective, randomized study comparing two different bone preparation techniques for insertion of a hydroxylapatite (HA) coated titanium cementless femoral stem. Patients who receive 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
The bone is pressed very hard together before implantation of femoral component.
bone preparation technique: compaction No other names.
The bone is pressed very hard together before implantation of femoral component.
(Active Comparator)
The bone is broached before implantation of femoral component.
bone preparation technique: conventional technique No other names.
Bone is broached before implantation of femoral component.

Primary Outcomes

To examine a possible difference in density of bones around implantation of femoral component.
time frame: 5 years

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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

Additional Information

Official title Compaction Femur Total Hip Arthroplasty (THA) Uni-lateral
Principal investigator Soeren Kold, MD
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Northern Orthopaedic Division, Denmark.