We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

ARTEBONE Bone Void Filler in Arthrodesis Procedure of the Ankle

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02480868
First Posted: June 25, 2015
Last Update Posted: July 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
BBS-Bioactive Bone Substitutes Oy
  Purpose
The purpose of this investigation is to assess safety and performance of ARTEBONE Bone Void Filler in the single arthrodesis procedure.

Condition Intervention
Osteoarthritis Device: ARTEBONE

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Clinical Investigation to Assess Safety and Performance of ARTEBONE as Bone Void Filler in a Single Arthrodesis Procedure of the Ankle (Ankle Joint or Subtalar Joint)

Resource links provided by NLM:


Further study details as provided by BBS-Bioactive Bone Substitutes Oy:

Primary Outcome Measures:
  • The incidence of unanticipated serious adverse device effects [ Time Frame: Before or at 12 months ]
  • Bone fusion rates [ Time Frame: At 6 months (plus or minus 2 weeks) ]
    Bone fusion rates assessed by sequential post-operative radiographs and Computer tomography at 6 months (both evaluated by two independent radiologists).

  • Bone fusion rates [ Time Frame: At 12 months (plus or minus 2 weeks) ]
    Bone fusion rates assessed by sequential post-operative radiographs at 12 months (evaluated by two independent radiologists).


Secondary Outcome Measures:
  • Adverse events [ Time Frame: Within 12 months ]

    Adverse events recorded either voluntarily by the subject in response to a non-leading question (i.e. "how have you been feeling?") or following a clinical observation.

    All adverse events will be assessed by the investigator according to their severity, relationship to the investigational product, action taken, and outcome status as defined in the ISO14155 guideline.


  • Time-points for returning to work [ Time Frame: Within 12 months ]
    Secondary performance endpoint

  • Functional performance (Scores of American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Scale) [ Time Frame: 6 months (plus or minus 2 weeks) ]
    Functional performance at 6 months, secondary performance endpoint

  • Functional performance (Scores of American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Scale) [ Time Frame: 12 months (plus or minus 2 weeks) ]
    Functional performance at 12 months, secondary performance endpoint

  • Subjective pain evaluation (VAS) for fusion site and at weight bearing [ Time Frame: 12 weeks (plus or minus 1 week) ]
    Secondary performance endpoint

  • Subjective pain evaluation (VAS) for fusion site and at weight bearing [ Time Frame: 6 months (plus or minus 2 weeks) ]
    Secondary performance endpoint

  • Subjective pain evaluation (VAS) for fusion site and at weight bearing [ Time Frame: 12 months (plus or minus 2 weeks) ]
    Secondary performance endpoint


Estimated Enrollment: 35
Study Start Date: January 2014
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ARTEBONE
Bone Void Filler
Device: ARTEBONE
4,3 g Bone Void Filler

Detailed Description:

This is a multi-centre, prospective clinical investigation in subjects in need of a single arthrodesis procedure of the ankle (ankle joint or subtalar joint) to relieve persistent pain due to primary or secondary osteoarthritis.

The objectives of the study are to assess safety and performance of ARTEBONE as Bone Void Filler in the single arthrodesis procedure of the ankle (ankle joint or subtalar joint).

The study will be monitored regularly by Clinical Research Associates (CRAs). Monitoring procedures include one or more visits designed to clarify all prerequisites before the study commences. Interim monitoring visits will take place on a regular basis according to a schedule fixed by mutual agreement. During these visits, the CRA will check for completion of the entries on the Case Report Forms (CRFs), their compliance with the Clinical Investigation Plan (CIP), the standard operating procedures (SOP), Good Clinical Practice and International Organization for Standardization 14155 (ISO 14155), and will compare the CRF entries with the source data, as well as update the Investigator´s File (IF).

Source data verification will be performed in an unassisted way (direct access to source documents), unless otherwise required by the local ethics committee.

The sample size of 30 subjects was considered adequate for the safety and performance evaluation in this indication based on earlier discussions with the authorities.

An interim analyses will be performed for 6 months data. There will be descriptive analysis only and comparison to literature. Literature search has been done according to European Union (EU) guidelines.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. The patient has undergone previous fusion surgery of the proposed fusion site.
  2. 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.
  3. There is radiographic evidence of bone cysts, segmental defects or growth plate fracture around the fusion site that may negatively impact bony fusion.
  4. The patient currently has untreated malignant neoplasm(s) at the surgical site, or is currently undergoing radio- or chemotherapy.
  5. The patient has severe diabetes with neuropathy.
  6. The patient has a metabolic disorder known to adversely affect the skeleton, other than primary osteoporosis or diabetes (e.g., renal osteodystrophy or hypercalcemia).
  7. The patient uses chronic medications known to affect the skeleton (e.g., glucocorticoid usage > 10 mg/day).
  8. The patient uses immunosuppressive treatment or medication for osteoporosis.
  9. The patient has systemic or severe local inflammation or infections.
  10. The patient has a pre-fracture neuromuscular or musculoskeletal deficiency which might limit the ability to perform objective functional measurements.
  11. 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.
  12. The patient has an allergy to reindeer protein.
  13. The patient has received an investigational therapy or approved therapy for investigational use within 30 days of surgery.
  14. 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.
  15. The patient is pregnant or a female intending to become pregnant during the study period.
  16. The patient is deemed morbidly obese (body mass index [BMI] > 45 kg/m2).
  17. The patient has a recent history of smoking during the past six months prior to screening for study entry.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02480868


Locations
Finland
Central Hospital of Central Finland
Jyväskylä, Finland, 40620
South Karelia Central Hospital
Lappeenranta, Finland, 53101
Oulu University Hospital
Oulu, Finland, 90220
Helsinki University Central Hospital Peijas
Vantaa, Finland, 00029
Poland
Autonomous Public Clinical Hospital No. 1 of Pomeranian Medical University in Szczecin named after professor Tadeusz Sokołowski
Szczecin, Poland, 71252
Sponsors and Collaborators
BBS-Bioactive Bone Substitutes Oy
Investigators
Principal Investigator: Juhana Leppilahti, Professor Oulu University Hospital
  More Information

Responsible Party: BBS-Bioactive Bone Substitutes Oy
ClinicalTrials.gov Identifier: NCT02480868     History of Changes
Other Study ID Numbers: ARTEBONE 01
First Submitted: April 9, 2015
First Posted: June 25, 2015
Last Update Posted: July 19, 2017
Last Verified: July 2016

Keywords provided by BBS-Bioactive Bone Substitutes Oy:
Primary or secondary osteoarthritis
fusion of the ankle

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases