Enrollment on hold
An Observational Study to Gather Real-World Data on the VOLT Wrist Treatment System
NCT No.: NCT 0 0
Study Type: OBSERVATIONAL
Phase:
Region: California - Northern
Acronym: VOLT
Official Title
An Observational Study to Gather Real-World Data on the VOLT Wrist Treatment System
Purpose
The purpose of this research is to evaluate your healing outcomes following your treatment with a bone plate. Bone plates are used for several different trauma applications including fixation of fractures, fusions, non-unions and malunions, or osteotomies. Bone plates are commonly used in bone healing procedures like the one you are undergoing. Tyber Medical LLC, (the manufacturer of the bone plate that will be used in your bone healing procedure) would like to gather information about the ability of their bone plate to support your bone healing procedure.
Detailed Description
Eligibility Criteria
Inclusion Criteria
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Subjects will be considered for inclusion in ARM 1 of this observational study if all of the following criteria are met:
1. Subject underwent treatment with the VOLT™ Wrist Treatment System within the last 3 years.
2. Subject is skeletally mature and at least 18 years of age at the time of surgery.
3. Subject has a final healing outcome determination with corresponding radiographs and/or CT scans for confirmation.
Subjects will be considered for inclusion in ARM 2 of this observational study if all of the following criteria are met:
1. Subject will undergo treatment with the VOLT™ Wrist Treatment System.
2. Subject is skeletally mature and at least 18 years of age at the time of surgery.
3. Subject will obtain a final healing outcome determination with corresponding radiographs and/or CT scans to confirm the final healing outcome.
4. Subject has signed a HIPAA authorization.
5. Subject has signed an informed consent.
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Exclusion Criteria
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Subjects will be excluded from ARM 1 of this observational study if they meet any of the following criteria:
1. Subject has not completed treatment with the VOLT™ Wrist Treatment System.
2. Subject was not skeletally mature or at least 18 years of age at the time of surgery.
3. Subject did not obtain a final healing outcome determination by his/her physician.
4. Subject did not obtain radiographs and/or CT scans to confirm his/her final healing outcome.
Subjects will be excluded from ARM 2 of this observational study if they meet any of the following criteria:
1. Subject has not signed the informed consent.
2. Subject will not undergo treatment with the VOLT™ Wrist Treatment System.
3. Subject is not skeletally mature or will not be 18 years of age at the time of surgery.
4. Subject has not signed a HIPAA authorization permitting research activities.
5. Subject is unable to complete the radiographs and/or CT scans required to determine final healing outcomes.
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Keywords and/or Specific Medical Conditions
Sponsors
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