Degenerative OsteoarthritisNCT01413061
Study of Subtalar Arthrodesis Using AlloStem® Versus Autologous Bone Graft
A study testing Subtalar Arthrodesis in people with Degenerative Osteoarthritis and Post-traumatic; Arthrosis, run by AlloSource at 5 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Degenerative Osteoarthritis, Post-traumatic; Arthrosis, Rheumatoid Arthritis & Other Inflammatory Polyarthropathies
- What is being tested?
- Subtalar Arthrodesis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 5 sitesUnited States
- Study dates
- Jun 2010to Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Institute for Foot and Ankle Reconstruction at Mercy
Baltimore, Maryland, 21202
Minnesota Orthopedic Sports Medicine Institute (MOSMI)
Edina, Minnesota, 55435
Campbell Clinic
Germantown, Tennessee, 38138
Orthopaedic Associates of Michigan
Grand Rapids, Michigan, 49525
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
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.
- Conditions
- Degenerative Osteoarthritis, Post-traumatic; Arthrosis, Rheumatoid Arthritis & Other Inflammatory Polyarthropathies, Rheumatoid Arthritis of Subtalar Joint
- Being tested
- Subtalar Arthrodesis
- Keywords
- Other Hindfoot Conditions requiring Subtalar Arthrodesis, Post-traumatic Arthritis
- Medical subject headings
- Joint Diseases, Osteoarthritis, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subtalar ArthrodesisProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| AlloStem Live Cellular Allograft | Active comparator | AlloStem is the combination of the Mesenchymal Stem Cells (MSC) derived from adipose with demineralized bone. Receives: Procedure: Subtalar Arthrodesis |
| Control: Autologous Bone Marrow Aspirate | Active comparator | Autologous bone graft is recovered from the patient's own tibia or iliac crest, for transplantation in the subtalar joint. Receives: Procedure: Subtalar Arthrodesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fusion Rate (%)(as determined by CT assessment)
Fusion Rate (%)(as determined by CT assessment)
Measured: 6 months post-op
Secondary outcomes (3)
Radiographic outcome assessments
Radiographic outcome assessments
Measured: Pre-operatively, 6 weeks, 3, 6, 12 and 24 months
Functional outcome measurements
FFI-R, SF-12
Measured: Pre-operatively, 6 weeks, 3, 6, 12 and 24 months
Functional outcome measurements
AOFAS
Measured: Pre-operatively, 3, 6, 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2011 (estimated)
- Study startJun 2010
- Primary completionFeb 2017
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- AlloSource
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christiaan Coetzee, MD, Principal investigator, Minnesota Orthopedic Sports Medicine Institute (MOSMI)Mark Myerson, MD, Principal investigator, Institute for Foot and Ankle Reconstruction at MercyJohn Anderson, MD, Principal investigator, Orthopaedic Associates of MichiganPaul Juliano, MD, Principal investigator, Milton S. Hershey Medical CenterAndrew Murphy, MD, Principal investigator, Campbell Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01413061
- Sponsor's protocol ID
- AlloSource Subtalar Fusion RCT
- Status last verified
- Apr 2018
- First submitted
- 8 Aug 2011
- Last updated
- 13 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Subtalar Arthrodesis Using AlloStem® Versus Autologous Bone Graft
- ClinicalTrials.gov ID
- NCT01413061
- Acronym / sponsor ID
- AlloSource Subtalar Fusion RCT
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- AlloSourceIndustry (pharma, biotech, devices)
- Study start
- Jun 2010 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 10 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AlloStem Live Cellular Allograft | Active comparator | Procedure: Subtalar ArthrodesisAlloStem is the combination of the Mesenchymal Stem Cells (MSC) derived from adipose with demineralized bone. |
| Control: Autologous Bone Marrow Aspirate | Active comparator | Procedure: Subtalar ArthrodesisAutologous bone graft is recovered from the patient's own tibia or iliac crest, for transplantation in the subtalar joint. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Subtalar Arthrodesis | Procedure or surgery | AlloStem Live Cellular Allograft, Control: Autologous Bone Marrow Aspirate |
Primary outcome
Fusion Rate (%)(as determined by CT assessment)
Time frame: 6 months post-op
Fusion Rate (%)(as determined by CT assessment)
3 secondary outcomes
Radiographic outcome assessments
Time frame: Pre-operatively, 6 weeks, 3, 6, 12 and 24 months
Functional outcome measurements
Time frame: Pre-operatively, 6 weeks, 3, 6, 12 and 24 months
Functional outcome measurements
Time frame: Pre-operatively, 3, 6, 12 and 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christiaan Coetzee, MD principal investigator
Minnesota Orthopedic Sports Medicine Institute (MOSMI)
Mark Myerson, MD principal investigator
Institute for Foot and Ankle Reconstruction at Mercy
John Anderson, MD principal investigator
Orthopaedic Associates of Michigan
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subtalar Arthrodesis in people with Degenerative Osteoarthritis and Post-traumatic; Arthrosis, run by AlloSource at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fusion Rate (%)(as determined by CT assessment) (time frame: 6 months post-op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2018.