E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10061683 |
E.1.2 | Term | Arthrodesis |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Evaluate the safety and clinical utility of a synthetic bone regeneration system (GEM OS1) in a representative clinical model (foot and ankle fusions). |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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 (9cc 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
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E.5 End points |
E.5.1 | Primary end point(s) |
Union rate (%) at 24 weeks (by independent assessment of CT scan). |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 10 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of the trial is defined as the last visit of the last subject undergoing the trial. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 3 |