TerminatedNot Applicable

Circumferential Vertebral Reconstruction of Osteoporotic Compression Fractures Using a Novel Bipedicular Peek Implant

Stopped: financial constraints

United States30 participantsStarted 2022-05-10

Plain-language summary

The RECONSTRUCT study is a multi-center, prospective, single arm, post-market, pilot study to evaluate clinical and radiologic outcome data regarding the use of the Vertebral Implant PEEK (VIP) implant in the treatment of symptomatic, acute (\<8week) vertebral compression fractures who have failed conservative care strategies.

Who can participate

Age range50 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.

Inclusion criteria

✓. For a patient rendered nonambulatory as a result of pain from a VCF, pain persisting at a level that prevents ambulation despite 24 hours of analgesic therapy; or
✓. For a patient with sufficient pain from a VCF such that physical therapy is intolerable, pain persisting at that level despite 24 hours of analgesic therapy; or
✓. For a patient with pain from a VCF, unacceptable side effects such as excessive sedation, confusion, or constipation as a result of the analgesic therapy necessary to reduce pain to a tolerable level.

What they're measuring

Number of adverse events

Timeframe: End of study at 18 months

Trial details

NCT IDNCT05337696

SponsorIcahn School of Medicine at Mount Sinai

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-03-07

View on ClinicalTrials.gov More Vertebral Compression Fractures trials