Osteoarthritis Clinical Trial
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)
Verified date | December 2017 |
Source | BBS-Bioactive Bone Substitutes Oy |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this investigation is to assess safety and performance of ARTEBONE Bone Void Filler in the single arthrodesis procedure.
Status | Completed |
Enrollment | 34 |
Est. completion date | December 14, 2017 |
Est. primary completion date | December 14, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Finland | Central Hospital of Central Finland | Jyväskylä | |
Finland | South Karelia Central Hospital | Lappeenranta | |
Finland | Oulu University Hospital | Oulu | |
Finland | Helsinki University Central Hospital Peijas | Vantaa | |
Poland | Autonomous Public Clinical Hospital No. 1 of Pomeranian Medical University in Szczecin named after professor Tadeusz Sokolowski | Szczecin |
Lead Sponsor | Collaborator |
---|---|
BBS-Bioactive Bone Substitutes Oy |
Finland, Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The incidence of unanticipated serious adverse device effects | Before or at 12 months | ||
Primary | 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) | |
Primary | 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 | 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. |
Within 12 months | |
Secondary | Time-points for returning to work | Secondary performance endpoint | Within 12 months | |
Secondary | Functional performance (Scores of American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Scale) | Functional performance at 6 months, secondary performance endpoint | 6 months (plus or minus 2 weeks) | |
Secondary | Functional performance (Scores of American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Scale) | Functional performance at 12 months, secondary performance endpoint | 12 months (plus or minus 2 weeks) | |
Secondary | Subjective pain evaluation (VAS) for fusion site and at weight bearing | Secondary performance endpoint | 12 weeks (plus or minus 1 week) | |
Secondary | Subjective pain evaluation (VAS) for fusion site and at weight bearing | Secondary performance endpoint | 6 months (plus or minus 2 weeks) | |
Secondary | Subjective pain evaluation (VAS) for fusion site and at weight bearing | Secondary performance endpoint | 12 months (plus or minus 2 weeks) |
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