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Compaction Total Hip Arthroplasty (THA) Bilateral

Primary Purpose

Coxarthrosis

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Bone preparation technique: compaction
Bone preparation technique: broaching
Sponsored by
Northern Orthopaedic Division, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coxarthrosis focused on measuring THA

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Northern Orthopaedic Division

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Compaction

Broaching

Arm Description

Compaction technique for femoral bone preparation prior to cementless femoral stem insertion.

Broaching technique for femoral bone preparation prior to cementless femoral stem insertion.

Outcomes

Primary Outcome Measures

Radiostereometric analysis
Stem subsidence (change) at 5 and 10 years measured with radiostereometric analysis

Secondary Outcome Measures

Periprosthetic bone mineral density
Periprosthetic bone mineral density measured with Dual Energy X-ray Absorptiometry (DXA)

Full Information

First Posted
April 23, 2006
Last Updated
December 16, 2020
Sponsor
Northern Orthopaedic Division, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT00317889
Brief Title
Compaction Total Hip Arthroplasty (THA) Bilateral
Official Title
Compaction THA Bilateral
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
May 2001 (undefined)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northern Orthopaedic Division, Denmark

4. Oversight

5. Study Description

Brief Summary
This is a prospective, randomized study comparing two different bone preparation techniques for insertion of a porous coated titanium cementless femoral stem. Patients receiving a bilateral total hip replacement are randomized to conventional broaching on one side and compaction on the other side. 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
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Compaction
Arm Type
Experimental
Arm Description
Compaction technique for femoral bone preparation prior to cementless femoral stem insertion.
Arm Title
Broaching
Arm Type
Active Comparator
Arm Description
Broaching technique for femoral bone preparation prior to cementless femoral stem insertion.
Intervention Type
Procedure
Intervention Name(s)
Bone preparation technique: compaction
Other Intervention Name(s)
No other names.
Intervention Type
Procedure
Intervention Name(s)
Bone preparation technique: broaching
Other Intervention Name(s)
No other names.
Primary Outcome Measure Information:
Title
Radiostereometric analysis
Description
Stem subsidence (change) at 5 and 10 years measured with radiostereometric analysis
Time Frame
5 and 10 years follow-up
Secondary Outcome Measure Information:
Title
Periprosthetic bone mineral density
Description
Periprosthetic bone mineral density measured with Dual Energy X-ray Absorptiometry (DXA)
Time Frame
5 years follow-up
Other Pre-specified Outcome Measures:
Title
Questionnaire
Description
Questionnaire of hip function
Time Frame
5 years follow-up

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
Søren Kold, MD
Organizational Affiliation
Northern Orthopaedic Division
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northern Orthopaedic Division
City
Aalborg And Farsø
State/Province
Aalborg
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

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Compaction Total Hip Arthroplasty (THA) Bilateral

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