This trial is active, not recruiting.

Condition coxarthrosis
Treatments bone preparation technique: compaction, bone preparation technique: broaching
Sponsor Northern Orthopaedic Division, Denmark
Start date May 2001
End date September 2016
Trial size 20 participants
Trial identifier NCT00317889, ON-04-002b-SKO


This is a prospective, randomized study comparing two different bone preparation techniques for insertion of a porous coated titanium cementless femoral stem. Patients receiving a bilateral total hip replacement are randomized to conventional broaching on one side and compaction on the other side.

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 single group assignment
Masking open label
Primary purpose treatment
Compaction technique for femoral bone preparation prior to cementless femoral stem insertion.
bone preparation technique: compaction No other names.
(Active Comparator)
Broaching technique for femoral bone preparation prior to cementless femoral stem insertion.
bone preparation technique: broaching No other names.

Primary Outcomes

Radiostereometric analysis
time frame: 10 years follow-up

Secondary Outcomes

Periprosthetic bone mineral density
time frame: 5 years follow-up

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 THA Bilateral
Principal investigator Søren Kold, MD
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Northern Orthopaedic Division, Denmark.