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

N

Northern Orthopaedic Division, Denmark

Status

Unknown

Conditions

Coxarthrosis

Treatments

Procedure: Bone preparation technique: conventional technique
Procedure: Bone preparation technique: compaction

Study type

Interventional

Funder types

Other

Identifiers

NCT00318396
ON-04-002a-SKO

Details and patient eligibility

About

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.

Enrollment

26 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

26 participants in 2 patient groups

Compaction
Experimental group
Description:
The bone is pressed very hard together before implantation of femoral component.
Treatment:
Procedure: Bone preparation technique: compaction
Conventional technique
Active Comparator group
Description:
The bone is broached before implantation of femoral component.
Treatment:
Procedure: Bone preparation technique: conventional technique

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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