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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Northern Orthopaedic Division, Denmark
ClinicalTrials.gov Identifier:
NCT00318396
First received: April 23, 2006
Last updated: September 12, 2014
Last verified: September 2014
  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 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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Compaction Femur Total Hip Arthroplasty (THA) Uni-lateral

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

Primary Outcome Measures:
  • To examine a possible difference in density of bones around implantation of femoral component. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    A check-up by means of DEXA scanning after 1 week, 1 year, 2 years and 5 years.


Enrollment: 26
Study Start Date: June 2004
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Compaction
The bone is pressed very hard together before implantation of femoral component.
Procedure: Bone preparation technique: compaction
The bone is pressed very hard together before implantation of femoral component.
Other Name: No other names.
Active Comparator: Conventional technique
The bone is broached before implantation of femoral component.
Procedure: Bone preparation technique: conventional technique
Bone is broached before implantation of femoral component.
Other Name: No other names.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Denmark
Northern Orthopaedic Division, Clinic Farsoe, Aalborg University Hospital
Farsoe, Northern Jutland, Denmark
Sponsors and Collaborators
Northern Orthopaedic Division, Denmark
Investigators
Principal Investigator: Soeren Kold, MD Northern Orthopaedic Division
Study Director: Kjeld Soeballe, MD, Prof. Aarhus University Hospital
  More Information

No publications provided

Responsible Party: Northern Orthopaedic Division, Denmark
ClinicalTrials.gov Identifier: NCT00318396     History of Changes
Other Study ID Numbers: ON-04-002a-SKO
Study First Received: April 23, 2006
Last Updated: September 12, 2014
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by Northern Orthopaedic Division, Denmark:
THA

Additional relevant MeSH terms:
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Osteoarthritis
Rheumatic Diseases

ClinicalTrials.gov processed this record on October 20, 2014