Clinical and Radiological Investigation of a New Spinal Fixateur Interne (Ennovate®)

Total Indications Ennovate® Non-Interventional Study on Clinical and Radiological Results With Pedicle Screw Fixation

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03550846

Acronym

TENNIS

Enrollment

188

Registered

2018-06-08

Start date

2018-04-12

Completion date

2022-11-18

Last updated

2023-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Fusion

Keywords

Spinal Fusion

Brief summary

This study is planned and conducted to document all patients in the participating Centers, who are treated with the CE-marked product, the Fixateur Ennovate®, regardless of the diagnosis or indication. Data on performance and safety of the product, validated patient based questionnaires (Oswestry Disability Index, ODI) as well as the satisfaction of the patients in general are captured.

Detailed description

The list of spinal treatments is growing, and healthcare authorities today are at times limiting their access due to a lack of evidence of safety and efficiency. The study enables a quick, but detailed implant documentation, which is of great interest for the current and future users of the internal fixation system targeted in this study. It includes the relevant outcomes to evaluate safety and efficacy of the implant system for various indications in trauma and degenerative disorders.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

\- Consent in the documentation of clinical and radiological results

Exclusion criteria

\- If it is clear that the patient cannot participate in a follow-up examination, he will be excluded from the study documentation.

Design outcomes

Primary

Measure	Time frame	Description
Change of Clinical Results from Preoperative Status to Follow-Up at 12 Months	preoperative, 12 months postoperative	Clinical Results measured by Oswestry Disability Index (ODI). ODI contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel, each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. Each question is scored on a scale of 0 (indicating the least amount of disability) to 5 5 (indicating most severe disability). The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.

Countries

Germany

Outcome results