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

NCT00318396 | Unknown DMC

• 1 other identifier: ON-04-002a-SKO
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coxarthrosis

Keywords

THA

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Compaction

EXPERIMENTAL

The bone is pressed very hard together before implantation of femoral component.

Procedure: Bone preparation technique: compaction

Conventional technique

ACTIVE COMPARATOR

The bone is broached before implantation of femoral component.

Procedure: Bone preparation technique: conventional technique

Interventions

Bone preparation technique: compaction PROCEDURE

The bone is pressed very hard together before implantation of femoral component.

Also known as: No other names.

Compaction

Bone preparation technique: conventional technique PROCEDURE

Bone is broached before implantation of femoral component.

Also known as: No other names.

Conventional technique

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northern Orthopaedic Division, Denmark: lead

Study Sites (1)

Northern Orthopaedic Division, Clinic Farsoe, Aalborg University Hospital

Farsø, Northern Jutland, Denmark

Location

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Soeren Kold, MD

  Northern Orthopaedic Division

  PRINCIPAL INVESTIGATOR

• Kjeld Soeballe, MD, Prof.

  Aarhus University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2006
• First Posted: April 26, 2006
• Study Start: June 1, 2004
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: April 12, 2017

Record last verified: 2017-04

Locations

DK (1)