Study of Subtalar Arthrodesis Using AlloStem® Versus Autologous Bone Graft
This study is ongoing, but not recruiting participants.
Sponsor:
AlloSource
Information provided by:
AlloSource
ClinicalTrials.gov Identifier:
NCT01413061
First received: August 8, 2011
Last updated: August 12, 2011
Last verified: August 2011
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Purpose
The purpose of this clinical trial is to evaluate the outcome of implanting AlloStem® graft with appropriate rigid internal fixation hardware as an alternative to autograft bone graft with rigid fixation in subtalar arthrodesis procedures. The primary objective of this clinical trial is to compare the overall fusion rate of the investigational to the control treatment. Fusion will be determined by clinical findings, radiographs and computed tomography (CT) of the subtalar joint 24 weeks (6 months) after the trial surgery.
| Condition | Intervention |
|---|---|
|
Degenerative Osteoarthritis Post-traumatic; Arthrosis Rheumatoid Arthritis and Other Inflammatory Polyarthropathies Rheumatoid Arthritis of Subtalar Joint |
Procedure: Subtalar Arthrodesis |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Study of Subtalar Arthrodesis Using AlloStem® Versus Autologous Bone Graft |
Resource links provided by NLM:
Further study details as provided by AlloSource:
Primary Outcome Measures:
- Fusion Rate (%)(as determined by CT assessment) [ Time Frame: 6 months post-op ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Radiographic outcome assessments [ Time Frame: Pre-operatively, 6 weeks, 3, 6, 12 and 24 months ] [ Designated as safety issue: No ]
- Functional outcome measurements [ Time Frame: Pre-operatively, 6 weeks, 3, 6, 12 and 24 months ] [ Designated as safety issue: No ]FFI-R, SF-12
- Functional outcome measurements [ Time Frame: Pre-operatively, 3, 6, 12 and 24 months ] [ Designated as safety issue: No ]AOFAS
| Enrollment: | 136 |
| Study Start Date: | June 2010 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: AlloStem Live Cellular Allograft | Procedure: Subtalar Arthrodesis |
| Active Comparator: Control: Autologous Bone Marrow Aspirate | Procedure: Subtalar Arthrodesis |
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Must be diagnosed with degenerative osteoarthritis, post-traumatic arthritis, inflammatory arthritis (ie: rheumatoid arthritis) or other conditions of the hindfoot requiring subtalar arthrodesis.
- Patients must be able to attend follow-up examinations for the duration of the trial.
- The patient is at least 18 years of age and skeletally mature, or less than 80 years of age at the time of surgery.
- Is willing and able to comply with the clinical trial plan and able to understand and sign the Patient Informed Consent Form.
Exclusion Criteria:
- Younger than 18 years old or older than 80 years old.
- Has a condition that prevents ambulation or completion of any of the trial measurements.
- Requires fusion of additional hindfoot or ankle joints simultaneously (i.e. a pantalar, tibiotalocalcaneal or triple arthrodesis). Concomitant midfoot or forefoot procedures, such as osteotomies, tendon or metatarsal procedures are not exclusionary.
- Has treatment planned for the arthrodesis which does not require the use of screws.
- Has any active infection of the hindfoot, a systemic infection or bacteremia.
- Has received any treatment within the past 12 months which may interfere with bone metabolism [bisphosphonates (Fosamax, Actonel, Boniva, Reclast) and calcitonin (Miacalcin)].
- Is scheduled to have any surgical procedure on the contralateral foot within 6 weeks before or after the study procedure.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01413061
Locations
| United States, Maryland | |
| Institute for Foot and Ankle Reconstruction at Mercy | |
| Baltimore, Maryland, United States, 21202 | |
| United States, Michigan | |
| Orthopaedic Associates of Michigan | |
| Grand Rapids, Michigan, United States, 49525 | |
| United States, Minnesota | |
| Minnesota Orthopedic Sports Medicine Institute (MOSMI) | |
| Edina, Minnesota, United States, 55435 | |
Sponsors and Collaborators
AlloSource
Investigators
| Principal Investigator: | Christiaan Coetzee, MD | Minnesota Orthopedic Sports Medicine Institute (MOSMI) |
| Principal Investigator: | Mark Myerson, MD | Institute for Foot and Ankle Reconstruction at Mercy |
| Principal Investigator: | John Anderson, MD | Orthopaedic Associates of Michigan |
More Information
No publications provided
| Responsible Party: | Clinical Marketing Manager, AlloSource |
| ClinicalTrials.gov Identifier: | NCT01413061 History of Changes |
| Other Study ID Numbers: | AlloSource Subtalar Fusion RCT |
| Study First Received: | August 8, 2011 |
| Last Updated: | August 12, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by AlloSource:
|
Other Hindfoot Conditions requiring Subtalar Arthrodesis Post-traumatic Arthritis |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Joint Diseases Osteoarthritis Musculoskeletal Diseases |
Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013