Arthrodesis Surgery Involving the Hindfoot or AnkleNCT03028415
AMPLEX Ankle Fusion and Hindfoot
A study testing AMPLEX and Autogenous Bone Graft (ABG) in people with Arthrodesis Surgery Involving the Hindfoot or Ankle, run by Ferring Pharmaceuticals at 36 sites in 2 countries.
Trial summary
To demonstrate that AMPLEX is non-inferior to autogenous bone graft (ABG) for bone fusion in a population indicated for single, double, or triple hindfoot arthrodesis or ankle arthrodesis surgery with supplemental graft material. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Arthrodesis Surgery Involving the Hindfoot or Ankle
- What is being tested?
- AMPLEX and Autogenous Bone Graft (ABG)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 36 sitesin 2 countries
- Study dates
- 28 Jul 2017to 9 Jul 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written informed consent
- Indicated for ankle or hindfoot arthrodesis and require one of the following arthrodesis procedures:
- Tibiotalar (ankle); Talocalcaneal (subtalar); Talonavicular; Calcaneocuboid; Double hindfoot (e.g., talonavicular and talocalcaneal joints); Triple hindfoot (subtalar, talonavicular and calcaneocuboid joints)
- Presents with pain on weight-bearing of at least 40 mm on a 100 mm VAS at the area indicated for arthrodesis
- Presents with at least one comorbid risk factors that warrant the use of supplemental autogenous bone or allograft:
- Radiographic evidence of bone defect, deficit, subsidence or subchondral cyst; More than one joint to be fused; Involvement of other adjacent or nonadjacent joints; Large surface area; Intra-articular or extra-articular deformity; Post-traumatic arthritis; Diagnosis of osteoporosis
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- The Investigator determines if the joint space(s) can be adequately filled with graft material (AMPLEX or ABG) according to the following parameters:
- Single hindfoot joint fusion: up to 5 cm^3; Double or triple hindfoot fusion: each individual joint up to 5 cm^3, but overall, not more than 10 cm3 for the full complement of joints; Ankle fusion: up to 10 cm^3
- Each fused joint can be rigidly stabilized with with at least 1 and no more than 3 screws across the fusion plane. (Supplemental pins and staples may be used, as well as supplemental screws and plates external to the fusion site(s))
- Willing and able to comply with all study requirements including all postoperative clinical and radiographic evaluations
- For women of childbearing potential (not post-menopausal for 12 months or surgically sterile), a urine pregnancy test with a negative result must be obtained at screening and within 24 hours prior to procedure. These trial participants must commit to adequate birth control (e.g., oral contraceptive, two methods of barrier birth control, or abstinence) through the 78 week follow-up
Who cannot join
- Bone deficit requiring a structural graft
- Charcot foot disease
- Radiographic evidence of open physes
- Prior arthroplasty, arthrodesis, major surgical repair or reconstruction of the index ankle or hindfoot joint(s)
- Requires osteotomy or fusion of the midfoot joints
- BMI greater than 45 kg/m^2
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- Documented medical history of, or radiographic evidence of, a bone disease (e.g. avascular necrosis) or other condition (e.g., osteolysis) that would preclude the subject from receiving screw fixation in the opinion of the surgeon
- Requires intramedullary nail fixation or an external fixator
- Comorbidity that would limit the ability to administer any functional measurements such as FAAM-ADL
- Has at the time of surgery, a systemic infection or local infection at the site of surgery
- Medical condition, serious intercurrent illness, or extenuating circumstance that, in the opinion of the Investigator, would preclude participation in the study or potentially decrease survival or interfere with ambulation or rehabilitation (e.g., history of transient ischemic attack, stroke or liver disease)
- HgbA1c level greater than or equal to 8%
- Known hypersensitivity to any of the components of the product [e.g. B2A peptide, Hydroxyapatite (HA): beta-tricalcium phosphate (βTCP), ceramic granule]
- Currently receiving treatment with a drug known to interfere with bone metabolism [e.g., systemic corticosteroid therapy (topical corticosteroid therapy is permissible), methotrexate]
- Has previously received treatment with a drug known to interfere with bone metabolism [e.g., systemic corticosteroid therapy (topical corticosteroid therapy is permissible), methotrexate] and in the opinion of the investigator could continue to negatively interfere with bone metabolism or bone healing
- History of any severe allergy or anaphylaxis, or a history of hypersensitivity to protein pharmaceuticals [e.g., monoclonal antibodies or gamma globulins, recombinant Bone Morphogenetic Proteins (BMPs)]
- Medical condition requiring radiation, chemotherapy or immunosuppression
- Have a prior or active history of malignancy (except for basal cell carcinoma of the skin)
- Has a history of autoimmune disease known to affect bone metabolism. Examples include spondyloarthropathies (e.g., ankylosing spondylitis, Crohn's disease, and ulcerative colitis), Juvenile Arthritis, Grave's disease and Hashimoto's thyroiditis; Rheumatoid Arthritis is allowed
- Have pathological or genetic liver disease or who have clinically significant, elevated baseline liver function enzymes
- Has obvious and/or documented alcohol or illicit drug addictions
- Is a prisoner in a correctional institution/facility
- Actively involved in litigation or workman's compensation
- Has participated in clinical studies evaluating investigational devices, pharmaceuticals or biologics within 6 months of randomization
- Requires chronic therapeutic use of NSAID during the first 6 post-operative weeks (except aspirin up to 325 mg bid for cardiovascular protection and/or DVT prophylaxis)
- Has previously been treated with, or exposed to, therapeutic levels of synthetic or recombinant BMPs
- Requires chronic subcutaneous or intravenous heparin therapies
Trial locations and contacts
36 sites in 2 countries.
36 sites in 2 countries
United States28 sites
Emory Orthopaedic and Spine Hospital
Atlanta, Georgia, 30329
University of Colorado School of Medicine
Aurora, Colorado, 80045
Sinai Hospital of Baltimore, Inc / Rubin Institute for Advanced Orthopedics
Baltimore, Maryland, 21215
Medstar
Baltimore, Maryland, 21218
TRIA Orthopaedic Center
Bloomington, Minnesota, 55431
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
OrthoCarolina Research Institute, Inc.
Charlotte, North Carolina, 28207
University of Virginia Health System
Charlottesville, Virginia, 22908
Midwest Orthopedics at Rush
Chicago, Illinois, 60612
University of Texas Medical Branch
Galveston, Texas, 77555-0165
Campbell Clinic Orthopaedics
Germantown, Tennessee, 38138
Physician Research Group
Gilbert, Arizona, 85295
Orthopaedic Associates of Michigan, Research and Education Institute
Grand Rapids, Michigan, 49525
Andrews Orthopaedic and Sports Medicine Center
Gulf Breeze, Florida, 32561
Hartford Hospital
Hartford, Connecticut, 06106
Baylor St. Luke's Medical Center
Houston, Texas, 77030
Michigan Orthopedic Center
Lansing, Michigan, 48910
Desert Orthopaedic Center
Las Vegas, Nevada, 89121
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Texas Tech University Health Sciences Center
Lubbock, Texas, 79430
Loyola University Medical Center
Maywood, Illinois, 60153
Rutgers
Newark, New Jersey, 07103
Pennsylvania Hospital
Philadelphia, Pennsylvania, 19106
Reconstructive Orthopaedic Associates
Philadelphia, Pennsylvania, 19107
Arizona Research Center
Phoenix, Arizona, 85053
University of Rochester School of Medicine
Rochester, New York, 14642
California Pacific Orthopaedics
San Francisco, California, 94118
University Orthopedics Center
State College, Pennsylvania, 16801
Canada8 sites
University of Alberta System
Edmonton, Alberta, T6G 2B7
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, B3H 3A7
Jewish General Hospital
Montreal, Quebec, H3T 1E2
Ottawa Hospital Research Institute
Ottawa, Ontario, K1Y 4E9
University of Laval
Québec, Quebec, G1V 4G2
Central Alberta Orthopedics
Red Deer, Alberta, T4N 6S4
St. Michael's Hospital
Toronto, Ontario, M5C 1R6
St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6
About this study
Official title: A Multi-Center, Randomized, Pivotal Study Evaluating AMPLEX Compared To Autogenous Bone Graft in Subjects Indicated for Arthrodesis Surgery Involving the Hindfoot or Ankle
To demonstrate that AMPLEX is non-inferior to autogenous bone graft (ABG) for bone fusion in a population indicated for single, double, or triple hindfoot arthrodesis or ankle arthrodesis surgery with supplemental graft material.
- Being tested
- AMPLEX, Autogenous Bone Graft (ABG)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMPLEXDevice
A bone graft substitute
Autogenous Bone Graft (ABG)Procedure or surgery
Control material administered by surgical implant
| Study group | Role | What they receive |
|---|---|---|
| AMPLEX | Experimental | Not described Receives: Device: AMPLEX |
| Autogenous Bone Graft (ABG) | Active comparator | Not described Receives: Procedure: Autogenous Bone Graft (ABG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Subjects Who Met All Five Criteria for Subject Performance Composite (SPC) Endpoint
Proportion of subjects who met all the following criteria for the SPC endpoint at 52 weeks: 1. Improvement in pain on weight-bearing at fusion site (≥20 mm reduction from baseline on 100 mm visual analog scale [VAS]); 2. Absence of significant graft harvest site pain (<20 mm on 100 mm VAS); 3. Improvement in Foot and Ankle Ability Measure Activities of Daily Living subscale (FAAM-ADL) (≥8 points improvement from baseline); 4. Absence of device related or procedure related serious adverse events (up to week 52); 5. Absence of secondary surgical or nonsurgical interventions intended to promote fusion (up to week 52).
The last observation carried forward was used for subjects with missing response status at 52 weeks.
Measured: At week 52
Secondary outcomes (18)
Proportion of Subjects Achieving Computerized Tomography (CT) Radiographic Fusion Success
Defined as ≥50% bone bridging across the joint space for the full complement of joints in the absence of secondary surgical or nonsurgical interventions intended to promote fusion.
The last observation carried forward was used for subjects with missing response status at 52 weeks.
Measured: At week 52
Proportion of Subjects Achieving CT Radiographic Fusion Success
Defined as ≥50% bone bridging across the joint space for the full complement of joints in the absence of secondary surgical or nonsurgical interventions intended to promote fusion.
Measured: At week 12
Proportion of Subjects Achieving CT Radiographic Fusion Success
Defined as ≥50% bone bridging across the joint space for the full complement of joints in the absence of secondary surgical or nonsurgical interventions intended to promote fusion.
Measured: At week 24
Proportion of Subjects With Change From Baseline in Pain on Weight-bearing at Fusion Site (>20 mm Reduction From Baseline on 100 mm VAS)
Weight-bearing pain at the fusion site was assessed using a 100 mm visual analog scale (VAS), a subject self-assessment questionnaire. Subjects were asked to mark the location on a 100 mm line corresponding to the amount of pain they experienced, with 0 mm being "no pain" and 100 mm being "the worst pain imaginable".
Improvement in pain on weight-bearing at the fusion site was defined as ≥ 20 mm reduction from baseline on 100 mm VAS, and is presented for this outcome measure.
Measured: Baseline, and at week 12
Proportion of Subjects With Change From Baseline in Pain on Weight-bearing at Fusion Site (>20 mm Reduction From Baseline on 100 mm VAS)
Weight-bearing pain at the fusion site was assessed using a 100 mm visual analog scale (VAS), a subject self-assessment questionnaire. Subjects were asked to mark the location on a 100 mm line corresponding to the amount of pain they experienced, with 0 mm being "no pain" and 100 mm being "the worst pain imaginable".
Improvement in pain on weight-bearing at the fusion site was defined as ≥ 20 mm reduction from baseline on 100 mm VAS, and is presented for this outcome measure.
Measured: Baseline, and at week 24
Proportion of Subjects With Change From Baseline in Pain on Weight-bearing at Fusion Site (>20 mm Reduction From Baseline on 100 mm VAS)
Weight-bearing pain at the fusion site was assessed using a 100 mm visual analog scale (VAS), a subject self-assessment questionnaire. Subjects were asked to mark the location on a 100 mm line corresponding to the amount of pain they experienced, with 0 mm being "no pain" and 100 mm being "the worst pain imaginable".
Improvement in pain on weight-bearing at the fusion site was defined as ≥ 20 mm reduction from baseline on 100 mm VAS, and is presented for this outcome measure.
Measured: Baseline, and at week 52
Proportion of Subjects With Absence of Graft Harvest Site Pain (<20 mm on 100 mm VAS)
Graft harvest site pain was assessed using a 100 mm visual analog scale (VAS), a subject self-assessment questionnaire, and was only assessed among subjects in the ABG group. Subjects in the ABG group were asked to mark the location on a 100 mm line corresponding to the amount of pain they experienced with 0 mm being "no pain" and 100 mm being "the worst pain imaginable".
Absence of significant graft harvest site pain was defined as <20 mm on 100 mm VAS, and is presented for this outcome measure.
Measured: At week 2
Proportion of Subjects With Absence of Graft Harvest Site Pain (<20 mm on 100 mm VAS)
Graft harvest site pain was assessed using a 100 mm visual analog scale (VAS), a subject self-assessment questionnaire, and was only assessed among subjects in the ABG group. Subjects in the ABG group were asked to mark the location on a 100 mm line corresponding to the amount of pain they experienced with 0 mm being "no pain" and 100 mm being "the worst pain imaginable".
Absence of significant graft harvest site pain was defined as <20 mm on 100 mm VAS, and is presented for this outcome measure.
Measured: At week 6
Proportion of Subjects With Absence of Graft Harvest Site Pain (<20 mm on 100 mm VAS)
Graft harvest site pain was assessed using a 100 mm visual analog scale (VAS), a subject self-assessment questionnaire, and was only assessed among subjects in the ABG group. Subjects in the ABG group were asked to mark the location on a 100 mm line corresponding to the amount of pain they experienced with 0 mm being "no pain" and 100 mm being "the worst pain imaginable".
Absence of significant graft harvest site pain was defined as <20 mm on 100 mm VAS, and is presented for this outcome measure.
Measured: At week 12
Proportion of Subjects With Absence of Graft Harvest Site Pain (<20 mm on 100 mm VAS)
Graft harvest site pain was assessed using a 100 mm visual analog scale (VAS), a subject self-assessment questionnaire, and was only assessed among subjects in the ABG group. Subjects in the ABG group were asked to mark the location on a 100 mm line corresponding to the amount of pain they experienced with 0 mm being "no pain" and 100 mm being "the worst pain imaginable".
Absence of significant graft harvest site pain was defined as <20 mm on 100 mm VAS, and is presented for this outcome measure.
Measured: At week 24
Proportion of Subjects With Absence of Graft Harvest Site Pain (<20 mm on 100 mm VAS)
Graft harvest site pain was assessed using a 100 mm visual analog scale (VAS), a subject self-assessment questionnaire, and was only assessed among subjects in the ABG group. Subjects in the ABG group were asked to mark the location on a 100 mm line corresponding to the amount of pain they experienced with 0 mm being "no pain" and 100 mm being "the worst pain imaginable".
Absence of significant graft harvest site pain was defined as <20 mm on 100 mm VAS, and is presented for this outcome measure.
Measured: At week 52
Change From Baseline in FAAM-ADL
Functional improvement was assessed using the Foot and Ankle Ability Measure Activities of Daily Living (FAAM-ADL) subscale, a subject self-assessment questionnaire that consists of 21 items pertaining to basic functional activities. Each item is scored on a 5 point Likert scale anchored by 4 (no difficulty at all) and 0 (unable to do). The total item subscale score ranges from 0 to 84, which are transformed to a scale of 0 to 100 as the final score. Higher scores represent a higher level of function, with 100 representing no dysfunction.
Measured: Baseline, and at week 12
Change From Baseline in FAAM-ADL
Functional improvement was assessed using the e Foot and Ankle Ability Measure Activities of Daily Living (FAAM-ADL) subscale, a subject self-assessment questionnaire that consists of 21 items pertaining to basic functional activities. Each item is scored on a 5 point Likert scale anchored by 4 (no difficulty at all) and 0 (unable to do). The total item subscale score ranges from 0 to 84, which are transformed to a scale of 0 to 100 as the final score. Higher scores represent a higher level of function, with 100 representing no dysfunction.
Measured: Baseline, and at week 24
Change From Baseline in FAAM-ADL
Functional improvement was assessed using the Foot and Ankle Ability Measure Activities of Daily Living (FAAM-ADL) subscale, a subject self-assessment questionnaire that consists of 21 items pertaining to basic functional activities. Each item is scored on a 5 point Likert scale anchored by 4 (no difficulty at all) and 0 (unable to do). The total item subscale score ranges from 0 to 84, which are transformed to a scale of 0 to 100 as the final score. Higher scores represent a higher level of function, with 100 representing no dysfunction.
Measured: Baseline, and at week 52
Subject Performance Composite (SPC) Endpoint
Proportion of subjects who met all the following criteria for the Subject Performance Composite (SPC) endpoint at 12 weeks: 1. Improvement in pain on weight-bearing at fusion site (≥20 mm reduction from baseline on 100 mm visual analog scale [VAS]); 2. Absence of significant graft harvest site pain (<20 mm on 100 mm VAS); 3. Improvement in Foot and Ankle Ability Measure Activities of Daily Living subscale (FAAM-ADL) (≥8 points improvement from baseline); 4. Absence of device related or procedure related serious adverse events (up to week 12); 5. Absence of secondary surgical or nonsurgical interventions intended to promote fusion (up to week 12).
Measured: At week 12
Subject Performance Composite (SPC) Endpoint
Proportion of subjects who met all the following criteria for the SPC endpoint at 24 weeks: 1. Improvement in pain on weight-bearing at fusion site (≥20 mm reduction from baseline on 100 mm visual analog scale [VAS]); 2. Absence of significant graft harvest site pain (<20 mm on 100 mm VAS); 3. Improvement in Foot and Ankle Ability Measure Activities of Daily Living subscale (FAAM-ADL) (≥8 points improvement from baseline); 4. Absence of device related or procedure related serious adverse events (up to week 24); 5. Absence of secondary surgical or nonsurgical interventions intended to promote fusion (up to week 24).
Measured: At week 24
Change From Baseline in Short Form-12 (SF-12)
The Short Form-12 (SF-12) Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health (psychological distress and psychological well-being). These eight domain scales were used to derive Physical Component Summary (PCS) and Mental Component Summary (MCS) scores. All scores were calculated through scoring software. Domain scales and component summary scores ranged from 0 to 100, with a higher score considered better.
Measured: Baseline, and at week 24
Change From Baseline in Short Form-12 (SF-12)
The Short Form-12 (SF-12) Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health (psychological distress and psychological well-being). These eight domain scales were used to derive Physical Component Summary (PCS) and Mental Component Summary (MCS) scores. All scores were calculated through scoring software. Domain scales and component summary scores ranged from 0 to 100, with a higher score considered better.
Measured: Baseline, and at week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2017 (estimated)
- Study start28 Jul 2017
- Primary completion9 Jan 2020
- Study completion9 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Arthrodesis Surgery Involving the Hindfoot or AnkleStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Compliance, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03028415
- Sponsor's protocol ID
- 000226
- Other IDs
- G150153
- Status last verified
- Aug 2020
- First submitted
- 19 Jan 2017
- Last updated
- 11 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Pivotal Study Evaluating AMPLEX Compared To Autogenous Bone Graft in Subjects Indicated for Arthrodesis Surgery Involving the Hindfoot or Ankle
- ClinicalTrials.gov ID
- NCT03028415
- Acronym / sponsor ID
- 000226
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 28 Jul 2017 (actual)
- Primary completion
- 9 Jan 2020 (actual)
- Study completion
- 9 Jul 2020 (actual)
- First posted
- 23 Jan 2017 (estimated)
- Results
- Posted 11 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To demonstrate that AMPLEX is non-inferior to autogenous bone graft (ABG) for bone fusion in a population indicated for single, double, or triple hindfoot arthrodesis or ankle arthrodesis surgery with supplemental graft material.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AMPLEX | Experimental | Device: AMPLEX |
| Autogenous Bone Graft (ABG) | Active comparator | Procedure: Autogenous Bone Graft (ABG) |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Signed written informed consent
- Indicated for ankle or hindfoot arthrodesis and require one of the following arthrodesis procedures:
- Tibiotalar (ankle); Talocalcaneal (subtalar); Talonavicular; Calcaneocuboid; Double hindfoot (e.g., talonavicular and talocalcaneal joints); Triple hindfoot (subtalar, talonavicular and calcaneocuboid joints)
- Presents with pain on weight-bearing of at least 40 mm on a 100 mm VAS at the area indicated for arthrodesis
- Presents with at least one comorbid risk factors that warrant the use of supplemental autogenous bone or allograft:
Key exclusion criteria (27 listed)
- Bone deficit requiring a structural graft
- Charcot foot disease
- Radiographic evidence of open physes
- Prior arthroplasty, arthrodesis, major surgical repair or reconstruction of the index ankle or hindfoot joint(s)
- Requires osteotomy or fusion of the midfoot joints
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 |
|---|---|---|
| AMPLEXA bone graft substitute | Device | AMPLEX |
| Autogenous Bone Graft (ABG)Control material administered by surgical implant | Procedure or surgery | Autogenous Bone Graft (ABG) |
Primary outcome
Proportion of Subjects Who Met All Five Criteria for Subject Performance Composite (SPC) Endpoint
Time frame: At week 52
Proportion of subjects who met all the following criteria for the SPC endpoint at 52 weeks: 1. Improvement in pain on weight-bearing at fusion site (≥20 mm reduction from baseline on 100 mm visual analog scale [VAS]); 2. Absence of significant graft harvest site pain (<20 mm on 100 mm VAS); 3. Improvement in Foot and Ankle Ability Measure Activities of Daily Living subscale (FAAM-ADL) (≥8 points improvement from baseline); 4. Absence of device related or procedure related serious adverse events (up to week 52); 5. Absence of secondary surgical or nonsurgical interventions intended to promote fusion (up to week 52). The last observation carried forward was used for subjects with missing response status at 52 weeks.
18 secondary outcomes
Proportion of Subjects Achieving Computerized Tomography (CT) Radiographic Fusion Success
Time frame: At week 52
Proportion of Subjects Achieving CT Radiographic Fusion Success
Time frame: At week 12
Proportion of Subjects Achieving CT Radiographic Fusion Success
Time frame: At week 24
Proportion of Subjects With Change From Baseline in Pain on Weight-bearing at Fusion Site (>20 mm Reduction From Baseline on 100 mm VAS)
Time frame: Baseline, and at week 12
Proportion of Subjects With Change From Baseline in Pain on Weight-bearing at Fusion Site (>20 mm Reduction From Baseline on 100 mm VAS)
Time frame: Baseline, and at week 24
Proportion of Subjects With Change From Baseline in Pain on Weight-bearing at Fusion Site (>20 mm Reduction From Baseline on 100 mm VAS)
Time frame: Baseline, and at week 52
Proportion of Subjects With Absence of Graft Harvest Site Pain (<20 mm on 100 mm VAS)
Time frame: At week 2
Proportion of Subjects With Absence of Graft Harvest Site Pain (<20 mm on 100 mm VAS)
Time frame: At week 6
Proportion of Subjects With Absence of Graft Harvest Site Pain (<20 mm on 100 mm VAS)
Time frame: At week 12
Proportion of Subjects With Absence of Graft Harvest Site Pain (<20 mm on 100 mm VAS)
Time frame: At week 24
Proportion of Subjects With Absence of Graft Harvest Site Pain (<20 mm on 100 mm VAS)
Time frame: At week 52
Change From Baseline in FAAM-ADL
Time frame: Baseline, and at week 12
Change From Baseline in FAAM-ADL
Time frame: Baseline, and at week 24
Change From Baseline in FAAM-ADL
Time frame: Baseline, and at week 52
Subject Performance Composite (SPC) Endpoint
Time frame: At week 12
Subject Performance Composite (SPC) Endpoint
Time frame: At week 24
Change From Baseline in Short Form-12 (SF-12)
Time frame: Baseline, and at week 24
Change From Baseline in Short Form-12 (SF-12)
Time frame: Baseline, and at week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Global Clinical Compliance study director
Ferring Pharmaceuticals
36 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AMPLEX and Autogenous Bone Graft (ABG) in people with Arthrodesis Surgery Involving the Hindfoot or Ankle, run by Ferring Pharmaceuticals at 36 sites in 2 countries.
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 11 inclusion and 27 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 11 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United States, Canada. 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?
Yes. Results are posted in the registry (first posted 11 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Proportion of Subjects Who Met All Five Criteria for Subject Performance Composite (SPC) Endpoint (time frame: At week 52). 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 11 Mar 2021.