OsseoScrew Versus Fenestrated Pedicle Screws Augmented With Polymethylmethacrylate

NCT01613144 | Completed FDA Device

• 1 other identifier: REC-000784
• Study Type: observational
• Target: 94
• Locations: 5 countries
• Sites: 10

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.

Conditions

Osteoporosis; Poor Bone Quality

Keywords

Osteopenia; Stenosis; Instability; Tumor

Outcome Measures

Primary Outcomes (2)

• Safety Endpoint: Rate of device-related or PMMA-related complications

  The proportion of patients who were free from device-related or PMMA-related complications leading to revision, supplemental fixation, non-elective removal, or reoperation throughout the study. Complications included, but were not limited to device or PMMA fracture, device or PMMA-related loosening, device or PMMA-related device disassembly, device migration or PMMA extravasation.

  24 months

• Efficacy Endpoint: Successful radiographic fusion

  Presence of continuous bridging bone across the implant

  24 months

Secondary Outcomes (3)

• Oswestry Disability Index

  24 months

• Visual Analogue Scale for back pain

  24 months

• Adverse events

  24 months

Study Arms (2)

OsseoScrew

Test Product: OsseoScrew Spinal Fixation System

Device: OsseoScrew Spinal Fixation System

Fenestrated Screw

Control Product: Any commercially available fenestrated screw system augmented with PMMA

Interventions

OsseoScrew Spinal Fixation System DEVICE

Surgical intervention

OsseoScrew

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• ≥ 18 years of age
• Spinal instability or deformity requiring fusion with instrumentation
• Osteopenia defined as (T-Score of less than -1.0)
• No response to nonoperative treatment modalities preceding enrollment.
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Alphatec Spine, Inc.: lead

Study Sites (10)

O.L. Vrouwziekenhuis

Aalst, Belgium

Location

CHIREC du Clinique

Brussels, Belgium

Location

ULB Hopital Erasme

Brussels, Belgium

Location

CHC St. Joseph

Liège, Belgium

Location

Katholisches Klinikum Koblenz - Montabaur/

Koblenz, Germany

Location

University Medical Center Mainz/

Mainz, Germany

Location

San Giovanni Addolorata Hospital

Rome, Italy

Location

Institut d'Assistència Sanitària

Girona, Spain

Location

Hospital de Leon

León, Spain

Location

The Royal National Orthopaedic Hospital

Stanmore, United Kingdom

Location

MeSH Terms

Conditions

Osteoporosis; Bone Diseases, Metabolic; Constriction, Pathologic; Neoplasms

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Bita Ghadimi

  Alphatec Spine, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2012
• First Posted: June 7, 2012
• Study Start: May 1, 2012
• Primary Completion: February 12, 2017
• Study Completion: November 8, 2017
• Last Updated: February 25, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2); IT (1); GB (1); ES (2); BE (4)