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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: May 1, 2013
Last verified: May 2013
History of Changes
  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: August 2013
Estimated Primary Completion Date: August 2013 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00318396

Locations
Denmark
Northern Orthopaedic Division, Clinic Farsoe and Aarhus 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: May 1, 2013
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
Osteoarthritis
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 19, 2013