Preheating of Femur Component in Hybrid Total Hip Arthrop... | NCT00319085

Studies
Preheating of Femur Component in Hybrid Total Hip Arthroplasty

NCT00319085

Sponsor

Northern Orthopaedic Division, Denmark

Status

Completed

Last Update Posted

Apr 10, 2015Estimated

Enrollment

80Actual

Phase

Phase 2

Conditions

Osteoarthritis, Hip

Interventions

Total hip replacement (Preheating of femur stem)

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 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2006

Primary Completion Date

Apr 2010Actual

Completion Date

Apr 2010Actual

First Submitted Date

Apr 27, 2006

First Submission Date that Met QC Criteria

Apr 27, 2006

First Posted Date

Apr 27, 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 9, 2015

Last Update Posted Date

Apr 10, 2015Estimated

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

Background

Recently published studies confirm that preheating of femoral component enhances shear strength of implant-cement interface. Both Iesaka et al 2003 and Jafri et al 2004 showed reduction in cement porosity on cement-implant interface with preheated femur components. We will use the radiostereometry analysis (RSA) to investigate how the preheating of femur component influence on prosthesis survivorship. There are no clinical controlled studies performed to the date.

The aim of the study

Comparison of the migration rates between preheated and non-preheated femur components, analyzed with RSA.

Methods

Randomization of 80 patients into 2 groups with 40 in each. All patients will undergo standard hybrid total hip replacement. In group one the femur component (Bi-Metric, Interlock Biomet) will be preheated to 40 degrees of Celsius before cementation. In group two: the control group, the femur component will be of room temperature. We will measure the temperature at cement bone interface during the operation with use of thermocouple electrodes inserted through separate drill hole in the femur. The measurements will be recorded every 10 seconds. The patients will follow the standard postoperative rehabilitation program.
The RSA analysis will be performed the first day after the operation and at 3, 12, 24 months postoperatively.
The Dual-energy X-ray absorptiometry scanning (DEXA) of the femur will be performed at the first week after the operation and at 12 and 24 months postoperatively.
The patients will be followed both clinically and radiologically at 1 and 2 years after the operation (Harris Hip Score).
The results will be expressed as mean + SD (in mm). ANOVA statistical analysis will be used to confirm the differences between the groups.

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

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Total hip replacement (Preheating of femur stem)	Procedure	Total hybrid hip arthroplasty, cementation of femural component, preheating, radiostereometry, DEXA

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Stem migration in mm		2 years

Secondary Outcomes

Measure	Description	Time Frame
Bone mineral density g/cm2		2 years
Temperature at bone-cement interface, degrees in Celsius		peroperatively
Serum- Titanium measurements in blood samples

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The patients suffering of hip osteoarthritis

Exclusion Criteria:

The patients with ASA score >II
The patients with cancer
The secondary coxarthrosis after the trauma
Any vascular or neuromuscular diseases affecting the hip.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

70 Years

Maximum Age

85 Years

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mogens B Jørgensen, M.D.	Northern Orthopaedic Division, Aalborg University Hospital, Denmark	Principal Investigator
Mogens B Laursen, M.D., Ph.D	Northern Orthopaedic Division, Aalborg University Hospital, Denmark	Principal Investigator
Lotte Borgwardt, dr.	Frederikberg Hospital, Copenhagen	Principal Investigator
Kjeld Søballe, Ph.D., MD.	University Hospital of Aarhus	Study Chair
Poul T Nielsen, M.D.	Northern Orthopaedic Division, Aalborg University Hospital, Denmark	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Farsoe Hospital, Northern Orthopaedic Division		Farsø		9640	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

Intervention Browse Module

MeSH Terms

ID	Term
D019644	Arthroplasty, Replacement, Hip

Ancestor Terms

ID	Term
D019643	Arthroplasty, Replacement
D001178	Arthroplasty
D019637	Orthopedic Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided