RecruitingNot ApplicableNCT05508360

"Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2)

Sponsor

Spinal Stabilization Technologies

Enrollment

72 participants

Start Date

Aug 22, 2022

Study Type

INTERVENTIONAL

Conditions

Chronic Low-back Pain Degenerative Disc Disease

Summary

This study will be a prospective, open-label, multi-center study including 72 patients that will collect additional safety and efficacy data for the Spinal Stabilization Technologies PerQdisc Nucleus Replacement System.

Eligibility

Min Age: 22 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called PerQdisc Nucleus Replacement System for people with chronic low-back pain and degenerative disc disease. The study is currently recruiting participants at 10 locations. People eligible for this study include aged 22 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEPerQdisc Nucleus Replacement System

Lumbar spine disc nucleus replacement system. All patients meeting all inclusion criteria and no exclusion criteria will be considered for nucleus replacement surgery following a review by the Medical Advisory Board.

Locations(11)

CIGE: Centro de Imunologia y Genetica

Medellín, Antioquia, Colombia

Fundacion Hospitalaria San Vicente de Paul

Medellín, Antioquia, Colombia

Cediul S.A.

Barranquilla, Atlántico, Colombia

Fundación Campbell

Barranquilla, Atlántico, Colombia

Sabbag Radiólogos S.A.

Barranquilla, Atlántico, Colombia

Sociedad de Cirugia de Bogota- Hospital de San Jose

Bogotá, D.C., Colombia

Clínica Imbanaco de Cali S.A.

Cali, Valle del Cauca Department, Colombia

Life Science Center for Innovation Hospital Clinica Biblica

San José, Costa Rica

Pacífica Salud Hospital Punta Pacífica

Panama City, Provincia de Panamá, Panama

Sanatario Americano

Asunción, Paraguay

Republican Specialized Scientific Practical Medical Center of Endocrinology named after Academician Y.Kh. Turakulova

Tashkent, Uzbekistan

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NCT05508360

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