CompletedNot Applicable

ARTEBONE Bone Void Filler in Arthrodesis Procedure of the Ankle

Finland, Poland34 participantsStarted 2014-01

Plain-language summary

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

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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 incidence of unanticipated serious adverse device effects

Timeframe: Before or at 12 months

Bone fusion rates

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

Bone fusion rates

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

NCT IDNCT02480868

SponsorBBS-Bioactive Bone Substitutes Oy

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-12-14

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.