PMCF Study on the Safety and Performance of PROSPACE 3D / PROSPACE 3D OBLIQUE / TSPACE 3D

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

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Recruitment Status

COMPLETED

Total Enrollment

208 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-23

Study Completion Date

2024-01-25

Brief Summary

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Prospective, pure data collection of all PROSPACE 3D, PROSPACE 3D Oblique, TSPACE 3D patients in selected centers (not interventional, multicenter

Detailed Description

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The study collects a data set for each patient receiving a PROSPACE 3D, PROSPACE 3D Oblique, or TSPACE 3D implant. It is intended to collect data preoperatively, intraoperatively and at one follow-up- assessment after a minimum of one year postoperatively containing

* Basic medical history
* Type of surgical procedure
* Treated segments
* Implant characteristics (including additional implants for anterior/posterior stabilization)
* Scores: ODI, Pain (VAS), EQ-5D
* Patient satisfaction

Conditions

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Degenerative Instability Spondylolisthesis Post-discectomy Syndrome Post-traumatic Instabilities

Keywords

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Lumbar interbody Fusion Intervertebral Implant

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patient is minimum 18 years old
* Written informed consent for the documentation of clinical and radiological results
* Patient's indication according to IFU
* Patient is not pregnant

Exclusion:

\- Patient is not willing or able to participate at the follow-up examination

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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Katholisches Klinikum Koblenz

Koblenz, , Germany

Site Status

Sana Kliniken Sommerfeld

Kremmen, , Germany

Site Status

Countries

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Germany

Other Identifiers

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AAG-O-H-2003

Identifier Type: -

Identifier Source: org_study_id