A randomized, controlled trial of the effect of Osigraft when used in the treatment of displaced femoral neck fractures – a pilot study

Stryker Biotech, LLC0 sitesNovember 24, 2005

ConditionsDisplaced femoral neck fractures are classified as Garden III and IV according to the Garden classification system for femoral neck fractures.MedDRA version: 8.0Level: PTClassification code 10016450

DrugsOsigraft 3.5 mg powder for suspension for implantation

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Displaced femoral neck fractures are classified as Garden III and IV according to the Garden classification system for femoral neck fractures.
Sponsor: Stryker Biotech, LLC
Status: Active, not recruiting
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

November 24, 2005

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Stryker Biotech, LLC

Eligibility Criteria

Inclusion Criteria

•To be eligible for study participation, a subject must meet all of the following criteria:
•1\. Subject is willing and able to understand, sign and date the study specific, Institutional Review Board/Ethics Committee approved patient informed consent and applicable privacy regulations.
•2\. Subject must require surgical treatment of a displaced intra\-capsular femoral neck fracture.
•3\. Subject must undergo definitive surgical intervention within 48 hours of the fracture.
•4\. Subject is skeletally mature (\=18 years of age or radiographic evidence of closure of epiphyses).
•5\. Subject will be less than 80 years of age at the time of study treatment.
•6\. Subject was able to ambulate independently prior to femoral neck fracture.
•7\. Subject agrees to participate in the post\-operative clinical evaluations.
•8\. Subject is male, or female of non\-childbearing potential, or female with a negative pregnancy test within 48 hours of definitive surgical intervention.
•Are the trial subjects under 18? no

Exclusion Criteria

•To be eligible for study participation, a patient must not meet any of the following criteria:
•1\. Subject is a pregnant or nursing woman, or a woman planning to become pregnant within 1 year following treatment.
•2\. Subject is of childbearing potential and is unwilling to use medically acceptable contraceptive methods such as surgical sterilization, hormonal contraceptives, barrier methods, or intrauterine devices so as to prevent pregnancy for one year following the internal fixation.
•3\. Subject has received another experimental drug, biologic or device as part of a study concurrent to or within 3 months prior to giving informed consent for this study.
•4\. Subject has a known hypersensitivity to any of the components of the product (e.g. recombinant human osteogenic protein (rhOP\-1\), type I bovine bone collagen matrix or other protein pharmaceuticals (e.g. monoclonal antibodies, gamma globulins)).
•5\. Subject who has a clinically significant organic disease, including cardiovascular, hepatic, pulmonary, neurologic, or renal disease, or established dementia or other medical condition, serious intercurrent illness, or extenuating circumstance that, in the opinion of the Investigator, would preclude participation in the trial or potentially decrease survival or interfere with ambulation or rehabilitation.
•6\. Subject has a history of malignancy.
•7\. Subject whose fracture is the result of a tumor or infection.
•8\. Subject with known metabolic bone disease or other condition (other than osteoporosis) which would negatively impact on the bone healing process (e.g. history of Paget’s disease or other osteodystrophy).
•9\. Subject has a history of pathological fractures.