Compaction Femur Preparation for Cementless Total Hip Art... | NCT00318396

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

NCT00318396

Sponsor

Northern Orthopaedic Division, Denmark

Status

Unknown status

Last Update Posted

Apr 12, 2017Actual

Enrollment

26Actual

Phase

Not Applicable

Conditions

Coxarthrosis

Interventions

Bone preparation technique: compaction
Bone preparation technique: conventional technique

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2004

Primary Completion Date

Dec 2017Estimated

Completion Date

Dec 2017Estimated

First Submitted Date

Apr 23, 2006

First Submission Date that Met QC Criteria

Apr 24, 2006

First Posted Date

Apr 26, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 11, 2017

Last Update Posted Date

Apr 12, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

26Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Bone preparation technique: compaction	Procedure	The bone is pressed very hard together before implantation of femoral component.	Compaction

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Soeren Kold, MD	Northern Orthopaedic Division	Principal Investigator
Kjeld Soeballe, MD, Prof.	Aarhus University Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Northern Orthopaedic Division, Clinic Farsoe, Aalborg University Hospital		Farsø	Northern Jutland		Denmark

Condition Browse Module

MeSH Terms

ID	Term
D015207	Osteoarthritis, Hip

Ancestor Terms

ID	Term
D010003	Osteoarthritis
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided