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Completed

NCT Number: NCT04542577

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

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

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Key information

Conditions

Degenerative Instability Bone Diseases Musculoskeletal Diseases Post-discectomy Syndrome Post-traumatic Instabilities Spinal Diseases Spondylolisthesis Spondylolysis Spondylosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Katholisches Klinikum Koblenz, Koblenz, Germany

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion:

  • 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

Treatment and study plan

Primary outcomes

  1. Change of Spinal Disability measured by Oswestry Disability Index (ODI)

    Time frame: preoperatively, at 3 months postoperatively and at 12 months postoperatively

    The Oswestry Disability Index (ODI) is designed to measure back-specific disability. The questionnaire has 10 items concerning pain and activities of daily living including pain, personal care, lifting, Walking, sitting, standing, sleeping, sex life, social life and travelling. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 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.

Secondary outcomes

  1. Change of Pain (VAS)

    Time frame: preoperatively, at 3 months postoperatively and at 12 months postoperatively

    Pain will be assessed by the patient using the Visual Analogue Scale (VAS) which state "0" at one end representing "no pain" and "100" at the opposite end representing "maximal/worst pain"

  2. Change of Quality of Life (EQ-5D)

    Time frame: preoperatively, at 3 months postoperatively and at 12 months postoperatively

    The score is self-completion by the patient and will therefore be used in German. The Quality of Life Score "EQ-5D" is a standardized 5-dimension 5-level measure of the health status and is developed by the EuroQol Group in order to have a simple and generic measure for clinical and economic assessment. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.

  3. Bone fusion

    Time frame: 12 Months postoperatively

    After IBF surgery fusion of the treated segment is aspired. Thus, the implant design shall allow on-/ingrowth to/into the material. The fusion status can be determined from radiographs (static or dynamic). Bony fusion can be characterized quantitatively by the fusion rate.

  4. Side effects

    Time frame: up to 12 months postoperatively

    Occurrence of complications potentially associated with the implanted devices can never be fully excluded during spinal surgery. In order to monitor potential complication and to identify so far unknown complications AEs and SAEs deemed related to the investigational device are recorded.

Sponsors and collaborators

Lead sponsor

Aesculap AG

Industry

Registry information

Official study title

Multicenter PMCF Study on the Safety and Performance of PROSPACE 3D / PROSPACE 3D OBLIQUE / TSPACE 3D - A Prospective Study on Total Indications

Acronym: PROTONTO

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
Sep 9, 2020
Registry last updated
Dec 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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