ARTEBONE Bone Void Filler in Arthrodesis Procedure of the Ankle

NCT02480868 | Completed

• 1 other identifier: ARTEBONE 01
• Study Type: interventional
• Target: 34
• Locations: 2 countries
• Sites: 5

Brief Summary

The purpose of this investigation is to assess safety and performance of ARTEBONE Bone Void Filler in the single arthrodesis procedure.

Conditions

Osteoarthritis

Keywords

Primary or secondary osteoarthritis; fusion of the ankle

Outcome Measures

Primary Outcomes (3)

• The incidence of unanticipated serious adverse device effects

  Before or at 12 months

• Bone fusion rates

  Bone fusion rates assessed by sequential post-operative radiographs and Computer tomography at 6 months (both evaluated by two independent radiologists).

  At 6 months (plus or minus 2 weeks)

• Bone fusion rates

  Bone fusion rates assessed by sequential post-operative radiographs at 12 months (evaluated by two independent radiologists).

  At 12 months (plus or minus 2 weeks)

Secondary Outcomes (7)

• Adverse events

  Within 12 months

• Time-points for returning to work

  Within 12 months

• Functional performance (Scores of American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Scale)

  6 months (plus or minus 2 weeks)

• Functional performance (Scores of American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Scale)

  12 months (plus or minus 2 weeks)

• Subjective pain evaluation (VAS) for fusion site and at weight bearing

  12 weeks (plus or minus 1 week)

Study Arms (1)

ARTEBONE

EXPERIMENTAL

Bone Void Filler

Device: ARTEBONE

Interventions

ARTEBONE DEVICE

4,3 g Bone Void Filler

ARTEBONE

Eligibility Criteria

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

You may qualify if:

• The patient has signed the independent ethics committee approved informed consent form specific to this investigation prior to enrollment.
• The patient is diagnosed with primary or secondary osteoarthritis requiring fusion of the ankle joint (tibiotalar) or the subtalar joint.
• The fusion site should be able to be rigidly stabilized with two or three screws across the fusion site.
• The patient is independent, ambulatory, and could comply with all post-operative evaluations and visits.
• The patient is at least 18 years of age and considered to be skeletally mature.

You may not qualify if:

• The patient has undergone previous fusion surgery of the proposed fusion site.
• The fusion site requires other than screw fixation, more than three screws across the fusion site to achieve rigid fixation, or more than one kit (3 cc) of graft material.
• There is radiographic evidence of bone cysts, segmental defects or growth plate fracture around the fusion site that may negatively impact bony fusion.
• The patient currently has untreated malignant neoplasm(s) at the surgical site, or is currently undergoing radio- or chemotherapy.
• The patient has severe diabetes with neuropathy.
• The patient has a metabolic disorder known to adversely affect the skeleton, other than primary osteoporosis or diabetes (e.g., renal osteodystrophy or hypercalcemia).
• The patient uses chronic medications known to affect the skeleton (e.g., glucocorticoid usage \> 10 mg/day).
• The patient uses immunosuppressive treatment or medication for osteoporosis.
• The patient has systemic or severe local inflammation or infections.
• The patient has a pre-fracture neuromuscular or musculoskeletal deficiency which might limit the ability to perform objective functional measurements.
• The patient is physically or mentally compromised (e.g., currently being treated for a psychiatric disorder, senile dementia, Alzheimer's disease, etc.) to the extent that the investigator judges the patient to be unable or unlikely to remain compliant.
• The patient has an allergy to reindeer protein.
• The patient has received an investigational therapy or approved therapy for investigational use within 30 days of surgery.
• The patient is a prisoner, known or suspected to be transient, or has a history of drug/alcohol abuse within the 12 months prior to screening for study entry.
• The patient is pregnant or a female intending to become pregnant during the study period.

Sponsors & Collaborators

• BBS-Bioactive Bone Substitutes Oy: lead

Study Sites (5)

Central Hospital of Central Finland

Jyväskylä, 40620, Finland

Location

South Karelia Central Hospital

Lappeenranta, 53101, Finland

Location

Oulu University Hospital

Oulu, 90220, Finland

Location

Helsinki University Central Hospital Peijas

Vantaa, 00029, Finland

Location

Autonomous Public Clinical Hospital No. 1 of Pomeranian Medical University in Szczecin named after professor Tadeusz Sokołowski

Szczecin, 71252, Poland

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Juhana Leppilahti, Professor

  Oulu University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2015
• First Posted: June 25, 2015
• Study Start: January 1, 2014
• Primary Completion: December 14, 2017
• Study Completion: December 14, 2017
• Last Updated: December 20, 2017

Record last verified: 2017-12

Locations

FI (4); PL (1)