A Study Evaluating Amplex Compared To Autograft Bone In Foot and Ankle Fusion Surgery

NCT01224119 | Unknown Phase 1 DMC

• 1 other identifier: AMX-200
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The current research study evaluates an investigational medical device called Amplex B2A(TM) Peptide Enhanced Ceramic Granules ("Amplex") for use in foot and ankle fusion. Amplex is a synthetic bone graft material. The most frequently used graft material is bone collected from the patient (autograft). Autograft involves a secondary incision with the risks of infection and lasting pain. The purpose of this study is to determine if Amplex is a safe and effective alternative to autograft.

Conditions

Arthritis

Keywords

foot ankle arthritis bone graft

Outcome Measures

Primary Outcomes (2)

• Radiographic fusion

  An independent radiologist will assess radiographic fusion based upon CT imaging.

  6 months

• Ankle Osteoarthritis Questionnaire

  This is a questionnaire completed by the subject. It consists of a number of questions concerning the amount of pain in the foot and its effect on functional activities.

  6 months

Secondary Outcomes (3)

• Ankle Osteoarthritis Questionnaire

  12 months

• Radiographic fusion

  9-12 months

• Various blood tests

  PreOp through 6 months

Study Arms (2)

Amplex (synthetic bone graft)

EXPERIMENTAL

Device: Amplex

Autograft bone

ACTIVE COMPARATOR

Procedure: Autograft bone

Interventions

Amplex DEVICE

225 micrograms of B2A per cc of ceramic granules

Amplex (synthetic bone graft)

Autograft bone PROCEDURE

Bone is collected through a separate incision at the iliac crest or tibia.

Autograft bone

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Indicated for foot and ankle surgery described as either a single, double or triple arthrodesis of the ankle, subtalar, calcaneocuboid or talonavicular joints.
• Have the ability to understand the requirements of the study, to provide written informed consent, and to comply with the study protocol
• Have the ability to understand and provide written authorization for the use and disclosure of personal health information (PHI)
• Be a skeletally mature male or a non-pregnant, non-lactating female at least 18 years of age but not older than age 75
• If a woman is of childbearing potential (not amenorrheic for the previous 24 months or not surgically sterile), then she must:
• Have a confirmed negative urine pregnancy test result prior to surgery and the administration of the study product
• Agree to use a medically approved method of contraception for the duration of the initial follow-up period of the study
• Agree to participate in postoperative clinical and radiographic evaluations and comply with the required study regimen
• Have not been sufficiently responsive to an adequate trial of non-operative treatment (e.g. modified activity, analgesics, anti-inflammatories, bracing, orthotics, physiotherapy, vitamin supplements, or injections etc. prior to study enrollment).

You may not qualify if:

• Has a large bone deficit requiring a structural graft
• Charcot joints from neuropathic destruction.
• Previous fusion or osteotomy of the proposed site
• Requires osteotomy or fusion of the midfoot joints
• Morbidly obese (BMI \>45 kg/m2)
• Women planning to become pregnant during the first year (12 months) following the procedure
• Female subjects of childbearing potential unwilling to use medically acceptable contraceptive methods (e.g., surgical sterilization, hormonal contraceptives, barrier methods, or intrauterine devices) so as to prevent pregnancy for 12 months following the study procedure
• Have at the time of surgery a systemic infection or local infection at the site of surgery
• Have an active history of systemic malignancy.
• Currently has untreated malignant neoplasm(s), or is currently undergoing radio- or chemotherapy or has been diagnosed with hypercalcemia.
• Have a 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., histories of transient ischemic attack, stroke or liver disease)
• Has a known complication of diabetes (e.g. retinopathy, renal failure, neuropathic complication in lower limb).
• Uncontrolled diabetes. If the patient has been diagnosed with diabetes, they must have an Hgb A1C level less than 7 to participate.
• Have a known hypersensitivity to any of the components of the product \[e.g., Hydroxyapatite (HA): Tricalcium Phosphate (TCP) ceramic granule\] or a known titanium allergy
• Receiving active treatment with a drug known to interfere with bone metabolism (e.g. long-term steroid therapy, methotrexate).

Sponsors & Collaborators

• BioSurface Engineering Technologies, Inc: lead

Study Sites (1)

Dr. Mark Glazebrook

Halifax, Nova Scotia, Canada

Location

Related Publications (1)

• Glazebrook M, Younger A, Wing K, Lalonde KA. A prospective pilot study of B2A-coated ceramic granules (Amplex) compared to autograft for ankle and hindfoot arthrodesis. Foot Ankle Int. 2013 Aug;34(8):1055-63. doi: 10.1177/1071100713481459. Epub 2013 Mar 5.

  PMID: 23463779 DERIVED

MeSH Terms

Conditions

Arthritis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• David M Hooper, PhD

  BioSurface Engineering Technologies, Inc

  STUDY DIRECTOR

• Mark Glazebrook, MD

  Queen Elizabeth II Health Sciences Center Halifax Infirmary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2010
• First Posted: October 19, 2010
• Study Start: January 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: March 9, 2012

Record last verified: 2012-03

Locations

CA (1)