Idys™ TLIF 3DTi Post Market Clinical Follow-up

Clariance

Status: Unknown

Conditions: Degenerative Disc Disease; Grade 1 Spondylolisthesis

Treatments: Device: Spine fusion surgery with Clariance Idys TLIF 3DTi

Study type: Observational

Funder types: Industry

Identifiers

NCT04584619

31PMCF-DrG

Details and patient eligibility

About

The aim of this observational post-marketing study is to provide additional information on the safety and effectiveness of Idys™ TLIF 3DTi at up to 24 months post transforaminal lumbar fusion in usual surgical practice.

Full description

The primary endpoint is to evaluate the effectiveness of the Idys™ TLIF (Transforaminal Lumbar Interbody Fusion) 3DTi (Porous Titanium additive manufacturing) by measuring the evolution of the rate of fusion during the postoperative period.

The secondary endpoints are to analyze the safety and the patient's benefit of the Idys™ TLIF 3DTi by evaluating several point of view:

• The adverse events related to the surgery;
• The functional improvement between preoperative state and the different follow-up time points using the Oswestry Disability Index (ODI);
• The improvement of back pain between preoperative state and the different follow-up time points using the Visual Analog Scale (VAS) (legs and back);
• The evolution of several radiologic lumbar parameters to assess the correction and its stability.

Enrollment: 25 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• English Speaking patients

• Patient with skeletal maturity

• Patient with

  • degenerative disc disease at one or two levels from L2 to S1 and/or
  • grade 1 spondylolisthesis

• Surgical treatment with Idys TLIF 3DTi interbody fusion device used in conjunction with a posterior fixation system (pedicle screws and rod).

Exclusion criteria

• Off-label indications.
• Any medical or surgical condition which would preclude the potential benefit of spinal implant surgery.
• Any patient having a prior fusion at the level to be treated.
• Any patient being vulnerable
• Non-English speakers