The Degen Study: Post-market Clinical Follow-up on the PASS LP, PASS Degen and PASS Tulip Systems (PASS DEGEN)

Medicrea

Status

Completed

Conditions

Thoracolumbar Spondylolisthesis

Spinal Degeneration

Spinal Deformity

Thoracolumbar Disc Degeneration

Treatments

Device: PASS DEGEN

Device: PASS LP implants

Device: PASS TULIP PRIME

Study type

Observational

Funder types

Industry

Identifiers

NCT04670536

0313

Details and patient eligibility

About

The purpose of this post-market clinical study is to evaluate the long-term safety and efficacy of the MEDICREA's systems PASS LP, PASS DEGEN, and PASS Tulip PRIME to treat degenerative diseases. This study is supporting the clinical evaluation report. From the standard-of-care perspective, the results of The Degen study are expected to contribute to a better understanding of expected safety and clinical outcomes from a short (intra- and peri-operative) to a medium-term follow-up (post-operatively).

Enrollment

77 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients of at least 18 years old
Patient suffering from a spinal degenerative disease.
Patient requiring spinal surgery for less than 4 levels for a spinal degenerative disease
Patient implanted with MEDICREA's products, or patients who are candidate to receive including at least the PASS LP and/or PASS DEGEN and/or PASS TULIP Prime implants
Patient affiliated to a national insurance system

Exclusion criteria

Patient unable or unwilling to sign and understand an information note with proof of patient consent
Patient unable to complete a self-administered questionnaire
Patient presenting contra-indications to a Xray follow-up
Patient of more than 18 years old under a protection procedure
Patient judged as non-compliant by the investigator or not able to come back for follow-up visits up to 2 years