CompletedNot Applicable

Retrospective Modulus ALIF Study

United States123 participantsStarted 2022-08-18

Plain-language summary

The primary objective of this study is to evaluate the safety and performance of the Modulus ALIF System in patients undergoing anterior lumbar interbody fusion (ALIF) as measured by reported complications, radiographic outcomes, and patient-reported outcomes.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Availability of progress notes and radiographic information preoperatively and a minimum of 6 months following surgery
✓. Male or female patients who are ≥18 years of age at the time of surgery
✓. Had undergone a regiment of at least six (6) months of nonoperative care treatment prior to being treated with the Modulus ALIF system, except in patients with progressive neurological deficits, neurogenic claudication causing significant disability, or developed cauda equine syndrome
✓. Treated with ALIF procedure with the Modulus ALIF System at:
✓. Supplemental fixation cleared by the applicable regulatory body for use in the thoracolumbar spine unless the procedure meets all of the following criteria:

Exclusion criteria

✕. Patient was a prisoner at the time of Modulus ALIF treatment
✕. Patient was participating in another clinical study during treatment that would confound study data

What they're measuring

Rates of complications attributable to the use of the Modulus ALIF System

Timeframe: 12 months

Proportion of subjects with apparent radiographic fusion at 6 months or greater postoperative

Timeframe: 12 months

Trial details

NCT IDNCT05566704

SponsorNuVasive

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2022-10-15

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