Back to resultsCompaction Femur Preparation for Cementless Total Hip Arthroplasty (THA) Unilateral
Primary Purpose
Coxarthrosis
Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Bone preparation technique: compaction
Bone preparation technique: conventional technique
Sponsored by
About this trial
This is an interventional treatment trial for Coxarthrosis focused on measuring THA
Eligibility 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
Sites / Locations
- Northern Orthopaedic Division, Clinic Farsoe, Aalborg University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Compaction
Conventional technique
Arm Description
The bone is pressed very hard together before implantation of femoral component.
The bone is broached before implantation of femoral component.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00318396
First Posted
April 23, 2006
Last Updated
April 11, 2017
Sponsor
Northern Orthopaedic Division, Denmark
1. Study Identification
Unique Protocol Identification Number
NCT00318396
Brief Title
Compaction Femur Preparation for Cementless Total Hip Arthroplasty (THA) Unilateral
Official Title
Compaction Femur Total Hip Arthroplasty (THA) Uni-lateral
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 2004 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northern Orthopaedic Division, Denmark
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coxarthrosis
Keywords
THA
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Compaction
Arm Type
Experimental
Arm Description
The bone is pressed very hard together before implantation of femoral component.
Arm Title
Conventional technique
Arm Type
Active Comparator
Arm Description
The bone is broached before implantation of femoral component.
Intervention Type
Procedure
Intervention Name(s)
Bone preparation technique: compaction
Other Intervention Name(s)
No other names.
Intervention Description
The bone is pressed very hard together before implantation of femoral component.
Intervention Type
Procedure
Intervention Name(s)
Bone preparation technique: conventional technique
Other Intervention Name(s)
No other names.
Intervention Description
Bone is broached before implantation of femoral component.
Primary Outcome Measure Information:
Title
To examine a possible difference in density of bones around implantation of femoral component.
Description
A check-up by means of DEXA scanning after 1 week, 1 year, 2 years and 5 years.
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Soeren Kold, MD
Organizational Affiliation
Northern Orthopaedic Division
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kjeld Soeballe, MD, Prof.
Organizational Affiliation
Aarhus University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Northern Orthopaedic Division, Clinic Farsoe, Aalborg University Hospital
City
Farsoe
State/Province
Northern Jutland
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Compaction Femur Preparation for Cementless Total Hip Arthroplasty (THA) Unilateral
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