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Demonstrate a larger proportion of subjects with healed fractures among subjects treated with InductOs and reamed, locked intramedullary nailing compared to subjects treated with reamed, locked intramedullary nailing alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | InductOs is rhBMP-2/ACS 1.5 mg/ml implanted once at the time of definitive fracture coverage +surgical fixation |
|
| B | Other | Standard of Care: Surgical fixation only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| InductOs | Drug | InductOs is rhBMP-2/ACS 1.5 mg/ml implanted once at the time of definitive fracture coverage |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Healed Fractures | Patients categorized by investigator as healed, not healed, no outcome (using pre-specified criteria). Healed: no tenderness at fracture site or pain with weight bearing, presence of bridging callus or disappearance of fracture lines, no hardware failure, no secondary intervention to promote fracture healing. Not healed: diagnosis of delayed union or nonunion, hardware failure, secondary intervention procedure for fracture healing recommended or performed, or conduct of procedure that may interfere with fracture healing. No outcome: subjects who did not achieve either healed or not healed. | 13 and 20 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Achieving Combined Clinical and Radiographic Endpoint (CCRE) | Patients categorized as Success or Failure of CCRE. Success defined as a fracture judged to be both clinically healed by clinical investigator, "healed" (see primary outcome), and radiographically united by independent, blinded radiology panel, "united." Patients deemed "not healed" or "not united" were assessed as failures. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer | Study Director |
| Trial Manager | For Germany, MedInfoDEU@wyeth.com | Principal Investigator |
| Trial Manager | For Italy, descresg@wyeth.com | Principal Investigator |
| Trial Manager | For South Africa, ZAFinfo@wyeth.com | Principal Investigator |
| Trial Manager | For Norway, Finland, MedInfoNord@wyeth.com | Principal Investigator |
| Trial Manager | For Spain, infomed@wyeth.com | Principal Investigator |
| Trial Manager | For UK/Great Britian, ukmedinfo@wyeth.com | Study Chair |
| Trial Manager | For Belgium, trials-BEL@wyeth.com | Principal Investigator |
| Trial Manager | For France, infomedfrance@wyeth.com | Principal Investigator |
| Trial Manager |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ghent | 9000 | Belgium | ||||
Assessment of the fractured limb was performed 24 hours before surgical fixation. Patients were stratified by severity of fracture (using Gustilo-Anderson Classification).
Patients were recruited worldwide from September 2003 to July 2007.
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| ID | Title | Description |
|---|---|---|
| FG000 | rhBMP-2/ACS | InductOs (dibotermin alfa) contains 12 mg of recombinant human bone morphogenetic protein-2 (rhBMP-2) in the form of a 1.5 mg/ml solution on an absorbable collagen sponge (ACS) implanted once at the time of definitive fracture coverage + surgical fixation |
| FG001 | Standard of Care |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 1 year |
| For Romania, WVPIMED@wyeth.com |
| Principal Investigator |
| Trial Manager | For Netherlands, trials-NL@wyeth.com | Principal Investigator |
| Turku |
| 20520 |
| Finland |
| Créteil | 94010 | France |
| Toulouse | 31400 | France |
| Berlin | 13353 | Germany |
| Mainz | 55131 | Germany |
| Münster | 48149 | Germany |
| Pavia | 27100 | Italy |
| Roma | 00168 | Italy |
| Rotterdam | 3015 GD | Netherlands |
| Bergen | 5021 | Norway |
| Oslo | 0407 | Norway |
| Bialystok | 15276 | Poland |
| Lublin | 20954 | Poland |
| Sosnowiec | 41200 | Poland |
| Szczecin | 71252 | Poland |
| Bucharest | 14461 | Romania |
| Bucharest | 21659 | Romania |
| Bucharest | 50098 | Romania |
| Bloemfontein | 9300 | South Africa |
| Cape Town | 7505 | South Africa |
| Cape Town | 7925 | South Africa |
| Centurion | 0157 | South Africa |
| Durban | South Africa |
| Alcalá | 28805 | Spain |
| Bristol | BS2 8HW | United Kingdom |
| Norwich | NR4 7 UY | United Kingdom |
Standard of Care: Surgical fixation only |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | rhBMP-2/ACS | InductOs (dibotermin alfa) contains 12 mg of recombinant human bone morphogenetic protein-2 (rhBMP-2) in the form of a 1.5 mg/ml solution on an absorbable collagen sponge (ACS) implanted once at the time of definitive fracture coverage + surgical fixation |
| BG001 | Standard of Care | Standard of Care: Surgical fixation only |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients With Healed Fractures | Patients categorized by investigator as healed, not healed, no outcome (using pre-specified criteria). Healed: no tenderness at fracture site or pain with weight bearing, presence of bridging callus or disappearance of fracture lines, no hardware failure, no secondary intervention to promote fracture healing. Not healed: diagnosis of delayed union or nonunion, hardware failure, secondary intervention procedure for fracture healing recommended or performed, or conduct of procedure that may interfere with fracture healing. No outcome: subjects who did not achieve either healed or not healed. | All patients randomized were analyzed. | Posted | Jul 2009 | Number | patients | 13 and 20 weeks |
|
|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients Achieving Combined Clinical and Radiographic Endpoint (CCRE) | Patients categorized as Success or Failure of CCRE. Success defined as a fracture judged to be both clinically healed by clinical investigator, "healed" (see primary outcome), and radiographically united by independent, blinded radiology panel, "united." Patients deemed "not healed" or "not united" were assessed as failures. | All patients randomized were analyzed. | Posted | Jun 2009 | Number | patients | 1 year |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | rhBMP-2/ACS | InductOs (dibotermin alfa) contains 12 mg of recombinant human bone morphogenetic protein-2 (rhBMP-2) in the form of a 1.5 mg/ml solution on an absorbable collagen sponge (ACS) implanted once at the time of definitive fracture coverage + surgical fixation | 31 | 127 | ||||
| EG001 | Standard of Care | Standard of Care: Surgical fixation only | 25 | 123 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abcess | General disorders | Non-systematic Assessment |
| ||
| Accidental injury | General disorders | Non-systematic Assessment |
| ||
| Cellulitis | General disorders | Non-systematic Assessment |
| ||
| Chest pain | General disorders | Non-systematic Assessment |
| ||
| Fever | General disorders | Non-systematic Assessment |
| ||
| Hardware failure | General disorders | Non-systematic Assessment |
| ||
| Infection | General disorders | Non-systematic Assessment |
| ||
| Pain | General disorders | Non-systematic Assessment |
| ||
| Peritonitis | General disorders | Non-systematic Assessment |
| ||
| Withdrawal syndrome | General disorders | Non-systematic Assessment |
| ||
| Deep vein thrombosis | Vascular disorders | Non-systematic Assessment |
| ||
| Embolus | Vascular disorders | Non-systematic Assessment |
| ||
| Pulmonary embolus | Vascular disorders | Non-systematic Assessment |
| ||
| Shock | Cardiac disorders | Non-systematic Assessment |
| ||
| Intestinal obstruction | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Healing abnormal | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Healing abnormal: bleeding at wound site | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Healing abnormal: delayed wound healing | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Healing abnormal: drainage, oozing, discharge | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Healing abnormal: superficial wound breakdown | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hyperglycemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hypocalcemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Peripheral edema | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| SGPT increased | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Arthritis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Bone disorder | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Bone fracture spontaneous | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Fracture delayed union | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Fracture malalignment | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Fracture nonunion | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Osteomyelitis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Delirium | Nervous system disorders | Non-systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Non-systematic Assessment |
| ||
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Hemoptysis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Skin necrosis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Skin ulcer | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Prostatic carcinoma | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fever | General disorders | Non-systematic Assessment |
| ||
| Hardware failure | General disorders | Non-systematic Assessment |
| ||
| Infection | General disorders | Non-systematic Assessment |
| ||
| Lab test abnormal | General disorders | Non-systematic Assessment |
| ||
| Pain | General disorders | Non-systematic Assessment |
| ||
| Anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Alkaline phosphatase increased | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Amylase increased | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hyperglycemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hypocalcemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hypokalemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hypophosphatemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Lactic dehydrogenase increased | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Peripheral edema | General disorders | Non-systematic Assessment |
| ||
| SGOT increased | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| SGPT increased | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Fractured delayed union | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Post operative heterotopic calcification | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Hypesthesia | General disorders | Non-systematic Assessment |
|
The PIs agreed to allow the sponsor 60 days to review and require changes to presentations or publications but only to protect confidential information and intellectual property, and for the sponsor to file a patent application, as applicable. The PIs also agreed for data to be presented first as a joint, multi-center publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| U. S. Contact Center | Wyeth | clintrialresults@wyeth.com |
| ID | Term |
|---|---|
| D013978 | Tibial Fractures |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D007869 | Leg Injuries |
Not provided
Not provided
| ID | Term |
|---|---|
| D055396 | Bone Morphogenetic Protein 2 |
| ID | Term |
|---|---|
| D019485 | Bone Morphogenetic Proteins |
| D055411 | TGF-beta Superfamily Proteins |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
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| Male |
|
| Week 13 No outcome |
|
| Week 20 Healed |
|
| Week 20 Not healed |
|
| Week 20 No outcome |
|
| 0.7983 |
| No |
| Superiority or Other |
|
|