Conduit Cages and Fibergraft BG Putty

Официальное название

Assess Clinical and Radiographic Outcomes of Conduit Cages and Fibergraft in Cervical and Lumbar Procedures

Обзор

The Conduit cages are intended to restore the intervertebral height and to facilitate the intervertebral body fusion in the cervical and lumbar spine in skeletally mature patients with degenerative disc disease and instabilities at one or more levels of the spine. The Fibergraft Bioactive Glass (BG) is engineered to mimic the body's natural bone healing process. While previous studies have described the use of conduit cages in interbody fixation procedures, these studies did not specifically study the clinical and radiographic outcomes of patients who have received these implants in addition to Fibergraft. We aim to recruit patients with degenerative disc disease, and instabilities at one to multilevel contiguous levels between C2-T1 and 1-2 contiguous levels between L2-S1 of the spine with accompanying radicular symptoms, ruptured or herniated discs, and pseudarthrosis and spondylodesis. We will then follow these patients for a duration of two years to report their clinical and radiographic outcomes to determine fusion, complication rate, and revision surgeries if any.

Вмешательства

• Устройство Use of conduit cages and fibergraft BG Putty
  Patients who require spine surgery under standard of care and meet the inclusion and exclusion criteria identified, will be recruited from clinic. Consent for participation in study will be signed at the same time as consent for surgery. All PROMs and scans will be done as standard of care and data will be obtained through chart review for this study.

Первичные конечные точки

• Fusion [Срок оценки: 2 years (At baseline, postoperatively at 6 weeks, 3 months, 6 months, 12 months, and 24 months)]

Вторичные конечные точки (4)

• Visual Analog Scale (VAS) [Срок оценки: 2 years (At baseline, postoperatively at 6 weeks, 3 months, 6 months, 12 months, and 24 months)]
• Oswestry Disability Index [Срок оценки: 2 years (At baseline, postoperatively at 6 weeks, 3 months, 6 months, 12 months, and 24 months)]
• SF-12 [Срок оценки: 2 years (At baseline, postoperatively at 6 weeks, 3 months, 6 months, 12 months, and 24 months)]
• Neck Disability Index [Срок оценки: 2 years (At baseline, postoperatively at 6 weeks, 3 months, 6 months, 12 months, and 24 months)]

Критерии участия

Критерии включения

• Age ≥ 18 years
• Have a radiograph-based diagnosis of degenerative disc disease, ruptured or herniated discs,
• Pathology of the cervical or lumbar spine.
• Pathology to be between C2-T1 in the cervical group.
• Pathology to be between L2-S1 in the lumbar group.
• Patients with 1-2 contiguous levels in both ACDF and Lumbar groups.
• Patients receiving the surgery/devices as standard of care prescribed by the treating physician.

Критерии исключения

• Patients < 18 years
• BMI > 40 kg/m2 to be excluded
• Patients with a bone density (DEXA) score of <2.0 to be excluded
• 3 or more levels for ACDF or Lumbar interbody to be excluded
• Patients with previous pseudoarthrosis or failed spondylodesis to be excluded
• Current smokers and patients who quit smoking within 6 weeks prior to presentation will be excluded

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

США · 1 центр

• University of Pittsburgh Medical Center — Pittsburgh

Идентификаторы

NCT: NCT06704919 · STUDY24040009

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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