Clinical trial NCT01613144: OsseoScrew Versus Fenestrated Pedicle Screws Augmented With Polymethylmethacrylate
Official title: Expandable Pedicle Screws Versus Fenestrated Pedicle Screws Augmented With Polymethylmethacrylate (PMMA): Complications and Clinical Outcomes in Patients With Osteoporosis or Poor Bone Quality
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoporosis
Poor Bone Quality
Keywords: Osteopenia
Stenosis
Instability
Tumor
Lead sponsor: Alphatec Spine, Inc.
Sponsor class: INDUSTRY
First posted: 2012-06-07
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 150 skeletally mature study subjects with spinal instability and osteopenia will be enrolled in the study. Subjects will be randomized 1:1 to the OsseoScrew or the control group.

Brief summary: The purpose of this clinical investigation was to collect clinical evidence of the safety and efficacy of the OsseoScrew System. The OsseoScrew System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion. The study was designed to compare the safety and efficacy of OsseoScrew compared to any other commercially available fenestrated pedicle screw system augmented with PMMA for posterior spinal fixation after surgical correction of spinal deformity or pathology.

Detailed description: This was a randomized, open-label, controlled, multi-center study in which patients were randomized in a 1:1 ratio to receive either the OsseoScrew or any commercially available fenestrated screw augmented with polymethylmethacrylate (PMMA) (Control group) for posterior spinal fixation after surgical correction of spinal deformity or pathology. The study was planned to include up to 150 skeletally mature patients with spinal instability and osteopenia at up to 10 sites. Patients were to return postoperatively at 6 weeks (± 2 weeks) and at 6, 12, and 24 months (± 2 months) for assessments.

Eligibility criteria: Inclusion Criteria:

1. ≥ 18 years of age
2. Spinal instability or deformity requiring fusion with instrumentation
3. Osteopenia defined as (T-Score of less than -1.0)
4. No response to nonoperative treatment modalities preceding enrollment.
5. Subject is willing and able to provide informed consent and agrees to release medical information for purposes of this study and to return for scheduled follow-up evaluations

Exclusion Criteria:

1. Active systemic or local infection
2. A life expectancy less than the study duration
3. Autoimmune disorders
4. Currently an alcohol, solvent, or drug abuser
5. Psychiatric or cognitive impairment that, in the opinion of the investigator, would interfere with the subject's ability to comply with the study requirements
6. History of allergies to any of the device components including but not limited to commercially pure titanium, titanium alloy, polymethylmethacrylate or Zirconium Oxide (ZrO2)

Primary outcomes:
measure: Safety Endpoint: Rate of device-related or PMMA-related complications
timeFrame: 24 months
measure: Efficacy Endpoint: Successful radiographic fusion
timeFrame: 24 months
Secondary outcomes:
measure: Oswestry Disability Index
timeFrame: 24 months
measure: Visual Analogue Scale for back pain
timeFrame: 24 months
measure: Adverse events
timeFrame: 24 months
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: O.L. Vrouwziekenhuis
city: Bruxelles
country: Belgium
facility: CHIREC du Clinique
city: Bruxelles
country: Belgium
facility: ULB Hopital Erasme
city: Liege
country: Belgium
facility: CHC St. Joseph
city: Koblenz
country: Germany
facility: Katholisches Klinikum Koblenz - Montabaur/
city: Mainz
country: Germany
facility: University Medical Center Mainz/
city: Rome
country: Italy
facility: San Giovanni Addolorata Hospital
city: Gerona
country: Spain
facility: Institut d'Assistència Sanitària
city: Leon
country: Spain
facility: Hospital de Leon
city: Stanmore
country: United Kingdom
facility: The Royal National Orthopaedic Hospital
Study officials:
affiliation: Alphatec Spine, Inc.
name: Bita Ghadimi
role: STUDY_DIRECTOR
References: