Study of Subtalar Arthrodesis Using AlloStem® Versus Autologous Bone Graft

Degenerative Osteoarthritis Clinical Trial

Official title:

Study of Subtalar Arthrodesis Using AlloStem® Versus Autologous Bone Graft

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01413061
• Other study ID #: AlloSource Subtalar Fusion RCT
• Status: Completed
• Phase: N/A
• First received: August 8, 2011
• Last updated: April 11, 2018
• Start date: June 2010
• Est. completion date: March 2018

Study information

• Verified date: April 2018
• Source: AlloSource
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: March 2018
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Degenerative Osteoarthritis
• Joint Diseases
• Osteoarthritis
• Post-traumatic; Arthrosis
• Rheumatoid Arthritis & Other Inflammatory Polyarthropathies
• Rheumatoid Arthritis of Subtalar Joint

Intervention

Procedure:
• Subtalar Arthrodesis

Locations

Country	Name	City	State
United States	Institute for Foot and Ankle Reconstruction at Mercy	Baltimore	Maryland
United States	Minnesota Orthopedic Sports Medicine Institute (MOSMI)	Edina	Minnesota
United States	Campbell Clinic	Germantown	Tennessee
United States	Orthopaedic Associates of Michigan	Grand Rapids	Michigan
United States	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
AlloSource

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fusion Rate (%)(as determined by CT assessment)	Fusion Rate (%)(as determined by CT assessment)	6 months post-op
Secondary	Radiographic outcome assessments	Radiographic outcome assessments	Pre-operatively, 6 weeks, 3, 6, 12 and 24 months
Secondary	Functional outcome measurements	FFI-R, SF-12	Pre-operatively, 6 weeks, 3, 6, 12 and 24 months
Secondary	Functional outcome measurements	AOFAS	Pre-operatively, 3, 6, 12 and 24 months