Compaction Total Hip Arthroplasty (THA) Bilateral

Coxarthrosis Clinical Trial

Official title:

Compaction THA Bilateral

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00317889
• Other study ID #: ON-04-002b-SKO
• Status: Completed
• Phase: N/A
• Start date: May 2001
• Est. completion date: September 2017

Study information

• Verified date: December 2020
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2017
• Est. primary completion date: September 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

• Bone preparation technique: broaching

Locations

Country	Name	City	State
Denmark	Northern Orthopaedic Division	Aalborg And Farsø	Aalborg

Sponsors (1)

Lead Sponsor	Collaborator
Northern Orthopaedic Division, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Questionnaire	Questionnaire of hip function	5 years follow-up
Primary	Radiostereometric analysis	Stem subsidence (change) at 5 and 10 years measured with radiostereometric analysis	5 and 10 years follow-up
Secondary	Periprosthetic bone mineral density	Periprosthetic bone mineral density measured with Dual Energy X-ray Absorptiometry (DXA)	5 years follow-up