Augment™ Injectable Bone Graft Compared to Autologous Bone Graft in Foot and Ankle Fusions

Ankle/Hindfoot Fusion Clinical Trial

Official title:

Prospective, Randomized, Controlled, Multi-Center, Pivotal Clinical Trial to Evaluate the Safety and Effectiveness of Augment™ Injectable Bone Graft Compared to Autologous Bone Graft as a Bone Regeneration Device in Foot and Ankle Fusions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01008891
• Other study ID #: BMTI-2009-01
• Status: Completed
• Phase: N/A
• First received: November 5, 2009
• Last updated: October 18, 2012
• Start date: September 2009
• Est. completion date: September 2011

Study information

• Verified date: October 2012
• Source: BioMimetic Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

Study Objective: To demonstrate equivalent clinical and radiologic outcomes as "gold standard" (ABG) in a representative clinical model (foot and ankle fusions)

Study Hypothesis: Augment™ Injectable is an equivalent bone grafting substitute to autologous bone graft in applications as shown by superiority analysis for safety and non-inferiority analysis for effectiveness

Study Rationale: Evaluate a fully synthetic bone graft material to facilitate fusion in conditions or injuries requiring bone graft in a representative clinical fusion model and thus the opportunity to provide equivalent union rates as ABG without necessitating an additional invasive procedure to harvest the graft

Description:

Musculoskeletal problems are pervasive throughout the population in all age groups and in both sexes. Half of Americans will need services for fractures at some point in their lifetime according to a widely published article presented at the 2003 annual meeting of the American Academy of Orthopedic Surgeons (AAOS). Many musculoskeletal problems, such as fractures and non-unions require bone graft to ensure adequate bone healing. One of the most widely used options for bone graft is autologous bone however; clinical difficulties have been associated with ABG (autologous bone graft). Most of these difficulties result from the harvest of the bone graft, including increased operative time, hospital stay and cost, increased blood loss, post-operative pain, risk of infection and/or fracture. The morbidity associated with ABG and its limited amount available to be harvested has directed surgeons to look for a better alternative for a chemotactic, mitogenic, and angiogenic bone graft substitute as an alternative for fracture augmentation to accelerate healing (St. John et al, 2003).

Currently, there are no generally accepted alternatives to ABG for fusion procedures of the foot or ankle. In order to demonstrate a product's effectiveness, it is necessary to show equivalence to autogenous bone graft in terms of safety and effectiveness. The purpose of this study is to examine the safety and efficacy of Augment™ Injectable Bone Graft (Beta-TCP/ Bovine Collagen matrix + rhPDGF-BB) in facilitating equivalent mean time to union as ABG in this foot and ankle fusion model. Our hypothesis is that the intraoperative application of Augment™ Injectable Bone Graft (Augment™ Injectable) in foot and ankle fusion procedures will demonstrate at least equivalent efficacy to that of the gold standard of autogenous bone graft while avoiding the trauma and sequelae associated with an additional surgical procedure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Bone defect in the hindfoot or ankle requiring fusion with supplemental bone graft/substitute, requiring one of the following procedures:

• Ankle joint fusion

• Subtalar fusion

• Calcaneocuboid fusion

• Talonavicular fusion

• Triple arthrodesis (subtalar, talonavicular and calcaneocuboid joints)

• Double fusions (any combination of any two of the following: subtalar, talonavicular and calcaneocuboid joints)

Exclusion Criteria:

• Previous fusion surgery of the proposed site

• Patient uses chronic medications known to affect the skeleton (e.g., glucocorticoid usage >10mg/day)

• Pregnant or a female intending to become pregnant during this study period

• Morbidly obese (BMI >45 kg/m2)

• Currently has untreated malignant neoplasm(s), or is currently undergoing radio- or chemotherapy or has been diagnosed with hypercalcemia.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ankle/Hindfoot Fusion

Intervention

Device:
• Augment™ Injectable
Beta-TCP/Bovine Collagen matrix + rhPDGF-BB

Procedure:
• Standard of care
Autologous Bone Graft

Locations

Country	Name	City	State
Canada	Peter Lougheed Center	Calgary	Alberta
Canada	Queen Elizabeth II Health Sciences Center	Halifax	Nova Scotia
Canada	The Ottawa Hospital, General Campus	Ottawa	Ontario
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	St. Paul's Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
BioMimetic Therapeutics

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fusion rate (%) as determined by CT assessment		24 weeks	No
Secondary	Radiographic outcome assessments, Functional outcome assessments, clinical outcomes		24 and 36 weeks	No