Compaction Femur Preparation for Cementless Total Hip Arthroplasty (THA) Unilateral

Coxarthrosis Clinical Trial

Official title:

Compaction Femur Total Hip Arthroplasty (THA) Uni-lateral

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00318396
• Other study ID #: ON-04-002a-SKO
• Status: Active, not recruiting
• Phase: N/A
• First received: April 23, 2006
• Last updated: April 11, 2017
• Start date: June 2004
• Est. completion date: December 2017

Study information

• Verified date: April 2017
• Source: Northern Orthopaedic Division, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 26
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Coxarthrosis
• Osteoarthritis, Hip

Intervention

Procedure:
• Bone preparation technique: compaction
The bone is pressed very hard together before implantation of femoral component.
• Bone preparation technique: conventional technique
Bone is broached before implantation of femoral component.

Locations

Country	Name	City	State
Denmark	Northern Orthopaedic Division, Clinic Farsoe, Aalborg University Hospital	Farsoe	Northern Jutland

Sponsors (1)

Lead Sponsor	Collaborator
Northern Orthopaedic Division, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To examine a possible difference in density of bones around implantation of femoral component.	A check-up by means of DEXA scanning after 1 week, 1 year, 2 years and 5 years.	5 years