For use as a bone void filler for voids or gaps that are not intrinsic to the stability of bony structure. Treatment of surgically created osseous defects or osseous defects resulting from pathology or taumatic injury to the bone in conjunction with standard measures. MedDRA version: 8.1 Level: LLT Classification code 10061683 Term: Arthrodesis
Conditions
Interventions
Product Name: GEM OS1
Pharmaceutical Form: Implant
INN or Proposed INN: Becaplermin
CAS Number: 165101-51-9
Other descriptive name: rh-PDGF-BB
Concentration unit: mg/ml milligram(s)/millilitre
Concent
Sponsors
BioMimetic Therapeutic Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)The patient has signed the Informed Consent Form prior to enrollment. 2)The patient has a bone defect in the foot or ankle requiring fusion with supplemental bone graft substitute, including: • ankle joint fusion • subtalar fusion, • triple arthrodesis fusion, • mid-foot fusion (1, 2, 3, or all 3 medial tarsometatarsal (TMT) joints, • naviculocuneiform (NC) joint fusion. 3)The fusion site is able to be rigidly stabilized with no more than 4 screws at each fusion site. Supplemental pins and screws may be used to stabilize the construct around the fusion site (e.g. fibular osteotomy). Plate fixation is not part of the study protocol and is excluded. 4)The patient is independent, ambulatory, and can comply with all post-operative evaluations and visits. 5)The patient is at least 18 years of age and skeletally mature. 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: 1)The patient has undergone previous surgery with development of an infection (i.e. abscess or osteomyelitis) of the proposed fusion site. 2)The fusion site requires plate fixation or more than 3 kits (9ml rh-PDGF BB or 15cc total graft material) of graft material to fill the void in the fusion space. 3)The patient currently has detectable untreated cancer or is currently undergoing radiotherapy or chemotherapy. 4)The patient has a metabolic disorder known to adversely affect the skeleton, other than primary osteoporosis or diabetes (e.g., renal osteodystrophy). 5)The patient uses chronic medications known to affect the skeleton (e.g. glucocorticoid usage > 10mg/day). Note: NSAIDs are allowable. 6)The patient has a pre-fracture neuromuscular or musculoskeletal deficiency which limits the ability to perform objective functional measurements. 7) The patient is physically or mentally compromised, such that the investigator deems the subject unable to provide appropriate informed consent or is unlikely to comply with protocol requirements. (e.g. bedridden, currently being treated for a significant psychiatric disorder, senile dementia, significant Alzheimer’s disease, etc.). 8)The patient has an allergy to yeast-derived products; 9)The patient has received an investigational therapy or approved therapy for investigational use within 30 days of surgery or during the follow-up phase of this study; 10)The patient is a prisoner, is known or suspected to be transient, or has a history of drug/alcohol abuse within the 12 months prior to screening for study entry. 11)The patient is pregnant or a female intending to become pregnant during this study period. A urine pregnancy test will be administered within 21 days of the surgical visit to any female unless she is post-menopausal, has been sterilized, or is practicing a medically-accepted method of contraception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the safety and clinical utility of a synthetic bone regeneration system (GEM OS1) in a representative clinical model (foot and ankle fusions).;Secondary Objective: Evaluation of safety by assessment of incidence of loss of reduction, infection, nonunion, and associated complications with foot and ankle fusion procedures. Occurrence of other adverse effects. Subjects will also be assessed for the development of antibodies to becaplermin.;Primary end point(s): Union rate (%) at 24 weeks (by independent assessment of CT scan). | — |
Countries
Austria, Belgium, France
Outcome results
None listed