Displaced femoral neck fractures are classified as Garden III and IV according to the Garden classification system for femoral neck fractures. MedDRA version: 8.0 Level: PT Classification code 10016450
Conditions
Interventions
Trade Name: Osigraft 3.5 mg powder for suspension for implantation
Product Name: Osigraft
Pharmaceutical Form: Implant
INN or Proposed INN: Eptotermin alfa
CAS Number: 129805-33-0
Other descriptive na
Sponsors
Stryker Biotech, LLC
Eligibility
Sex/Gender
All
Inclusion 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 Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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. 10. Subject has a history of heterotropic ossification. 11. Subject is receiving treatment with a drug that interferes with bone metabolism. 12. Subject currently being treated with radiation, chemotherapy, immunosuppression, or chronic steroid therapy (prednisone use up to 5 mg/qd or its equivalent is allowed). 13. Subject has radiographic evidence of osteoarthritis in the injured hip. 14. Subject has a history of rheumatoid arthritis. 15. Subject has other fractures that would interfere with ambulation or rehabilitation. 16. Subject has previously received a bone morphogenic protein (e.g. Osigraft). 17. Subject has had previous surgical intervention at the fracture site. 18. Subject has a condition which places him/her at risk for osteomyelitis. 19. Subject has an ASA Physical Status Classification greater than 2. 20. Subject has a life expectancy less than 24 months. 21. Subject whose fracture is anticipated to be reduced in an open procedure.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The overall objective of this pilot study is to evaluate the following: 1. The effects of Osigraft on clinical outcomes, bone healing and functional recovery in patients with displaced intra-capsular femoral neck fracture. 2. To evaluate the safety of Osigraft under the conditions of the trial. 3. To evaluate the feasibility of performing protocol procedures in preparation for a pivotal study. ;Secondary Objective: ;Primary end point(s): To evaluate the following in preparation for a pivotal study: • Proportion of patients requiring secondary surgical intervention • Weight bearing as assessed by Investigator • Proportion of patients with non-union and/or avascular necrosis (as judged by blinded independent radiologists) • Time to radiological union (as judged by blinded independent radiologists) • Functional outcomes (SF-36, EQ-5D) • Safety profile including Adverse Event (AE) and Serious Adverse Event (SAE) rates • Harris and Charnley-D’Aubigne-Postel Hip Scores • Visual Analog Scale for pain (hip pain) | — |
Countries
United Kingdom
Outcome results
None listed