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

NCT04542577 | Completed

• 1 other identifier: AAG-O-H-2003
• Study Type: observational
• Target: 208
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Degenerative Instability; Spondylolisthesis; Post-discectomy Syndrome; Post-traumatic Instabilities

Keywords

Lumbar interbody Fusion; Intervertebral Implant

Outcome Measures

Primary Outcomes (1)

• Change of Spinal Disability measured by Oswestry Disability Index (ODI)

  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.

  preoperatively, at 3 months postoperatively and at 12 months postoperatively

Secondary Outcomes (4)

• Change of Pain (VAS)

  preoperatively, at 3 months postoperatively and at 12 months postoperatively

• Change of Quality of Life (EQ-5D)

  preoperatively, at 3 months postoperatively and at 12 months postoperatively

• Bone fusion

  12 Months postoperatively

• Side effects

  up to 12 months postoperatively

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All Patients undergoing PROSPACE 3D, PROSPACE 3D OBLIQUE or TSPACE 3D surgery in the participating Hospitals meeting the inclusion criteria are included in the study.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Aesculap AG: lead

Study Sites (2)

Katholisches Klinikum Koblenz

Koblenz, 56073, Germany

Location

Sana Kliniken Sommerfeld

Kremmen, 16766, Germany

Location

MeSH Terms

Conditions

Spondylolisthesis

Condition Hierarchy (Ancestors)

Spondylolysis; Spondylosis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Design

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

Study Record Dates

• First Submitted: September 2, 2020
• First Posted: September 9, 2020
• Study Start: September 23, 2020
• Primary Completion: January 9, 2023
• Study Completion: January 25, 2024
• Last Updated: December 18, 2024

Record last verified: 2024-12

Locations

DE (2)