NCT03501810

Brief Summary

Study to Assess the Safety and Performance of the OrtoWell® Distractor in Patients Undergoing Spinal Surgery

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 12, 2018

Completed
24 days until next milestone

Study Start

First participant enrolled

April 5, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 18, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
Last Updated

April 18, 2018

Status Verified

April 1, 2018

Enrollment Period

4 months

First QC Date

March 12, 2018

Last Update Submit

April 17, 2018

Conditions

Spinal Surgery

Outcome Measures

Primary Outcomes (1)

  • Device Reliability

    Assessed by positioning accuracy,holding capability and ease of use

    During the procedure

Secondary Outcomes (10)

  • Length of Procedure (hours)

    During the procedure

  • Major complications

    Intra and peri operative periods

  • Major complications

    1 month

  • Hospital stay

    Assessed at Discharge, approximately 3 days

  • Minor complications

    1 month

  • +5 more secondary outcomes

Interventions

Distractor use for vertebrae separationDEVICE

Distractor use where separation of vertebrae is required, including corpectomy, insertion of disc prosthesis, insertion of an anterior lumbar interbody fusion (ALIF) cage, and tumor surgery

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing anterior or lateral spinal surgery, where separation of vertebrae is required, including corpectomy, insertion of disc prosthesis, insertion of an anterior lumbar interbody fusion (ALIF) cage, and tumor surgery

You may qualify if:

  • Patients undergoing spinal surgery, where use of the OrtoWell® Distractor System is indicated
  • Signed written informed consent

You may not qualify if:

  • Pregnant patients at the time of spinal surgery
  • Known osteoporosis
  • BMI ≥ 30
  • Obstacles to performing radioscopy (primarily lateral), such as obesity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitätsklinikum Bonn

Bonn, 53127, Germany

RECRUITING

Related Publications (1)

  • Bornemann R, Himstedt J, Boszczyk B, Bowald S, Sander K, Mikulowski S, Farhoud HMES, Pflugmacher R. A Prospective Clinical Study to Evaluate Safety and Performance of an Intra-Surgical Hydraulic Distractor During Spinal Surgeries. Med Devices (Auckl). 2025 Oct 24;18:525-536. doi: 10.2147/MDER.S537601. eCollection 2025.

    PMID: 41164796DERIVED

Study Officials

  • Robert Pflugmacher, Prof

    University Hospital, Bonn

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stan Mikulowski

CONTACT

46 8 558 093 69stan.mikulowski@ortoway.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2018

First Posted

April 18, 2018

Study Start

April 5, 2018

Primary Completion

July 31, 2018

Study Completion

September 30, 2018

Last Updated

April 18, 2018

Record last verified: 2018-04

Locations

DE(1)