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OsteoarthritisNCT02480868

ARTEBONE Bone Void Filler in Arthrodesis Procedure of the Ankle

A study testing ARTEBONE in people with Osteoarthritis, run by BBS-Bioactive Bone Substitutes Oy at 5 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Osteoarthritis
What is being tested?
ARTEBONE
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
5 sitesin 2 countries
Study dates
Jan 2014to 14 Dec 2017
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).
Show all 17Show fewer
  • 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.
  • The patient is deemed morbidly obese (body mass index [BMI] > 45 kg/m2).
  • The patient has a recent history of smoking during the past six months prior to screening for study entry.

Trial locations and contacts

5 sites in 2 countries.

5 sites in 2 countries

Finland4 sites

  • Central Hospital of Central Finland

    Jyväskylä, 40620

  • South Karelia Central Hospital

    Lappeenranta, 53101

  • Oulu University Hospital

    Oulu, 90220

  • Helsinki University Central Hospital Peijas

    Vantaa, 00029

Other trials in Finland

Poland1 site

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

    Szczecin, 71252

Other trials in Poland

About this study

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)

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

Read the 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.

Conditions
Osteoarthritis
Being tested
ARTEBONE
Keywords
Primary or secondary osteoarthritis, fusion of the ankle
Medical subject headings
Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ARTEBONEDevice

    4,3 g Bone Void Filler

Study groups in NCT02480868
Study groupRoleWhat they receive
ARTEBONEExperimentalBone Void Filler
Receives: Device: ARTEBONE

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The incidence of unanticipated serious adverse device effects

    Measured: Before or at 12 months

  2. Bone fusion rates

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

    Measured: At 6 months (plus or minus 2 weeks)

  3. Bone fusion rates

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

    Measured: At 12 months (plus or minus 2 weeks)

Secondary outcomes (7)

  1. Adverse events

    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.

    Measured: Within 12 months

  2. Time-points for returning to work

    Secondary performance endpoint

    Measured: Within 12 months

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

    Functional performance at 6 months, secondary performance endpoint

    Measured: 6 months (plus or minus 2 weeks)

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

    Functional performance at 12 months, secondary performance endpoint

    Measured: 12 months (plus or minus 2 weeks)

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

    Secondary performance endpoint

    Measured: 12 weeks (plus or minus 1 week)

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

    Secondary performance endpoint

    Measured: 6 months (plus or minus 2 weeks)

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

    Secondary performance endpoint

    Measured: 12 months (plus or minus 2 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2015 (estimated)
  2. Study startJan 2014
  3. Primary completion14 Dec 2017
  4. Study completion14 Dec 2017

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02480868
Sponsor's protocol ID
ARTEBONE 01
Status last verified
Dec 2017
First submitted
9 Apr 2015
Last updated
20 Dec 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing ARTEBONE in people with Osteoarthritis, run by BBS-Bioactive Bone Substitutes Oy at 5 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 5 inclusion and 17 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 20 Dec 2017. 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 Finland, Poland. 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?

The incidence of unanticipated serious adverse device effects (time frame: Before or at 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02480868.

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 20 Dec 2017.

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