Clinical trial NCT01413061: Study of Subtalar Arthrodesis Using AlloStem® Versus Autologous Bone Graft
Official title: Study of Subtalar Arthrodesis Using AlloStem® Versus Autologous Bone Graft
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Degenerative Osteoarthritis
Post-traumatic; Arthrosis
Rheumatoid Arthritis & Other Inflammatory Polyarthropathies
Rheumatoid Arthritis of Subtalar Joint
Keywords: Other Hindfoot Conditions requiring Subtalar Arthrodesis
Post-traumatic Arthritis
Lead sponsor: AlloSource
Sponsor class: INDUSTRY
First posted: 2011-08-10
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Must be diagnosed with degenerative osteoarthritis, post-traumatic arthritis, inflammatory arthritis (ie: rheumatoid arthritis) or other conditions of the hindfoot requiring subtalar arthrodesis.
2. Patients must be able to attend follow-up examinations for the duration of the trial.
3. The patient is at least 18 years of age and skeletally mature, or less than 80 years of age at the time of surgery.
4. Is willing and able to comply with the clinical trial plan and able to understand and sign the Patient Informed Consent Form.

Exclusion Criteria:

1. Younger than 18 years old or older than 80 years old.
2. Has a condition that prevents ambulation or completion of any of the trial measurements.
3. 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.
4. Has treatment planned for the arthrodesis which does not require the use of screws.
5. Has any active infection of the hindfoot, a systemic infection or bacteremia.
6. Has received any treatment within the past 12 months which may interfere with bone metabolism \[bisphosphonates (Fosamax, Actonel, Boniva, Reclast) and calcitonin (Miacalcin)\].
7. Is scheduled to have any surgical procedure on the contralateral foot within 6 weeks before or after the study procedure.

Primary outcomes:
measure: Fusion Rate (%)(as determined by CT assessment)
timeFrame: 6 months post-op
Secondary outcomes:
measure: Radiographic outcome assessments
timeFrame: Pre-operatively, 6 weeks, 3, 6, 12 and 24 months
measure: Functional outcome measurements
timeFrame: Pre-operatively, 6 weeks, 3, 6, 12 and 24 months
measure: Functional outcome measurements
timeFrame: Pre-operatively, 3, 6, 12 and 24 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Institute for Foot and Ankle Reconstruction at Mercy
state: Maryland
city: Grand Rapids
country: United States
facility: Orthopaedic Associates of Michigan
state: Michigan
city: Edina
country: United States
facility: Minnesota Orthopedic Sports Medicine Institute (MOSMI)
state: Minnesota
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
city: Germantown
country: United States
facility: Campbell Clinic
state: Tennessee
Study officials:
affiliation: Minnesota Orthopedic Sports Medicine Institute (MOSMI)
name: Christiaan Coetzee, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute for Foot and Ankle Reconstruction at Mercy
name: Mark Myerson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Orthopaedic Associates of Michigan
name: John Anderson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Milton S. Hershey Medical Center
name: Paul Juliano, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Campbell Clinic
name: Andrew Murphy, MD
role: PRINCIPAL_INVESTIGATOR
References: