WithdrawnNot Applicable

A Multi-Center, Prospective Registry to Evaluate the Continued Safety and Performance of Clavicle Plates

Stopped: The study was suspended and terminated.

United States0Started 2021-05-20

Plain-language summary

The objective of the registry is to evaluate the continued safety and performance of Arthrex Clavicle Plates used to treat clavicle fractures.

Age range18 Years

SexALL

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

✓. The subject requires surgery using the Arthrex Clavicle Plate for clavicle fracture.
✓. The subject is 18 years of age or over.
✓. The subject is not considered a vulnerable subject (i.e., child, pregnant, nursing, prisoner, or ward of the state).
✓. Subject signed informed consent and is willing and able to comply with all study requirements

✕. Insufficient quantity or quality of bone.
✕. Blood supply limitations and previous infections, which may retard healing.
✕. Foreign-body sensitivity.
✕. Any active infection or blood supply limitations.
✕. Conditions that tend to limit the patient's ability or willingness to restrict activities or follow directions during the healing period.
✕. Subjects that are skeletally immature.

To assess a change in Visual Analogue Scale (VAS) survey

Timeframe: Preoperatively, 3 months, 6 months and 12 months postoperatively

To assess a change in Veterans Rand 12-Item Health Survey (VR-12)

Timeframe: Preoperatively, 3 months, 6 months and 12 months postoperatively

To assess a change in American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES)

Timeframe: Preoperatively, 3 months, 6 months and 12 months postoperatively

NCT IDNCT04986553

SponsorArthrex, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-07-30