Use of Radiostereometric Analysis Beads (RSA) to Measure Motion in the Spine, Following Lumbar Spinal Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Radiostereometric Analysis (RSA) is a new imaging technique used to measure motions in the spine. It provides more accurate measurements that could help in diagnosing problems in the spine earlier than standard xray techniques.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Assessment of segmental spinal motion has been and continues to be a difficult clinical problem. X-ray measurement error of up to 10 degrees for simple measurements for flexion, extension and side bending have been recorded. It is extremely difficult to measure small changes in vertebral alignment that may prove to have clinical significance. The measurement accuracy of the RSA technique far exceeds any manual techniques to date. RSA allows the surgeon to monitor spatial relationships within the spine over time with a much higher accuracy then conventional techniques.

This is a non-randomized prospective study design looking at the use of RSA in spinal surgery patients. Subjects in this study will undergo their indicated surgery. Prior to closure, they will be implanted with tantalum beads, which will serve as landmarks when the RSA film pairs are taken post-operatively. The subjects will have standard post-operative x-rays 6 weeks-3 months post-op and again at 12 months post-op. Yearly visits after this are anticipated for 5-10 years with proper funding.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Spinal Fusion Lumbar Discectomy

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

spinal motion tantalum beads

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Radiostereometric Analysis beads inserted during surgery

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients undergoing Spinal fusion or discectomy

Exclusion Criteria

* pregnant women

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bruce E. Fredrickson, MD

Role: PRINCIPAL_INVESTIGATOR

State University of New York - Upstate Medical University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

SUNY Upstate Medical University

Syracuse, New York, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SUNY UMU IRB# 4715

Identifier Type: -

Identifier Source: org_study_id