Spinal SurgeryNCT03501810
Study Assessing Safety and Performance of OrtoWell Distractor in Patients Undergoing Spinal Surgery
An observational study of Spinal Surgery, run by OrtoWay AB at 1 site in Germany.
Trial summary
Study to Assess the Safety and Performance of the OrtoWell® Distractor in Patients Undergoing Spinal Surgery Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Spinal Surgery
- What is being tested?
- Distractor use for vertebrae separation
- Type of treatment
- Medical device
- How many people
- 32 participants
- Where
- 1 siteGermany
- Study dates
- 5 Apr 2018to 30 Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Patients undergoing spinal surgery, where use of the OrtoWell® Distractor System is indicated
- Signed written informed consent
Who cannot join
- Pregnant patients at the time of spinal surgery
- Known osteoporosis
- BMI ≥ 30
- Obstacles to performing radioscopy (primarily lateral), such as obesity
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Universitätsklinikum Bonn
Bonn, 53127
Robert Pflugmacher
About this study
Official title: Prospective, Single-Arm, Post-Market Clinical Follow-up (PMCF) Study to Further Assess the Safety and Performance of the OrtoWell® Distractor in Patients Undergoing Spinal Surgery
Study to Assess the Safety and Performance of the OrtoWell® Distractor in Patients Undergoing Spinal Surgery
Read the detailed description
This is a Prospective, single-arm, multi-center, observational, post-market clinical follow-up study The OrtoWell® Distractor System (CE marked) is a device intended for separating and holding apart vertebral bodies in the spinal column, to facilitate removal of damaged discs, and implantation of disc prostheses or spinal cage prostheses, as well as for repositioning the vertebral bodies following implantation of disc or cage prostheses The OrtoWell® Distractor System will be used in 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 The study will enroll up to 32 patients in Germany that require one of the above listed intervention except the patients with a known osteoporosis Study subjects are expected to participate for approximately 30 days following the surgery. Participation will involve a screening period, surgery and scheduled follow-up assessment at 30 days post implant
- Conditions
- Spinal Surgery
- Being tested
- Distractor use for vertebrae separation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Device Reliability
Assessed by positioning accuracy,holding capability and ease of use
Measured: During the procedure
Secondary outcomes (10)
Length of Procedure (hours)
Length of Procedure
Measured: During the procedure
Major complications
Evaluation of the major complications (cardiopulmonary, stroke, wound complications)
Measured: Intra and peri operative periods
Major complications
Major complications at 1 month
Measured: 1 month
Hospital stay
Total duration of hospital stay assessed at Discharge
Measured: Assessed at Discharge, approximately 3 days
Minor complications
Minor complications at 1 month
Measured: 1 month
All cause mortality
All cause mortality at 1 month
Measured: 1 month
Re operation
Re operation at 1 month
Measured: 1 month
Re hospitalization
Re hospitalization at 1 month
Measured: 1 month
Device related SAE
Device related SAE at 1 month
Measured: 1 month
All AEs
All AEs at 1 month
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start5 Apr 2018
- Primary completion31 Jul 2018 (estimated)
- Study completion30 Sep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OrtoWay AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MedPass International
- Responsible party
- Sponsor
- Investigators
- Robert Pflugmacher, Prof, Principal investigator, University Hospital, Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03501810
- Sponsor's protocol ID
- 01-2017
- Status last verified
- Apr 2018
- First submitted
- 12 Mar 2018
- Last updated
- 18 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 41164796
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Single-Arm, Post-Market Clinical Follow-up (PMCF) Study to Further Assess the Safety and Performance of the OrtoWell® Distractor in Patients Undergoing Spinal Surgery
- ClinicalTrials.gov ID
- NCT03501810
- Acronym / sponsor ID
- 01-2017
- Conditions
- Spinal Surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- OrtoWay ABIndustry (pharma, biotech, devices)
- Collaborators
- MedPass International
- Study start
- 5 Apr 2018 (actual)
- Primary completion
- 31 Jul 2018 (estimated)
- Study completion
- 30 Sep 2018 (estimated)
- First posted
- 18 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study to Assess the Safety and Performance of the OrtoWell® Distractor in Patients Undergoing Spinal Surgery
Detailed description
This is a Prospective, single-arm, multi-center, observational, post-market clinical follow-up study The OrtoWell® Distractor System (CE marked) is a device intended for separating and holding apart vertebral bodies in the spinal column, to facilitate removal of damaged discs, and implantation of disc prostheses or spinal cage prostheses, as well as for repositioning the vertebral bodies following implantation of disc or cage prostheses The OrtoWell® Distractor System will be used in 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 The study will enroll up to 32 patients in Germany that require one of the above listed intervention except the patients with a known osteoporosis Study subjects are expected to participate for approximately 30 days following the surgery. Participation will involve a screening period, surgery and scheduled follow-up assessment at 30 days post implant
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- Patients undergoing spinal surgery, where use of the OrtoWell® Distractor System is indicated
- Signed written informed consent
Key exclusion criteria (4 listed)
- Pregnant patients at the time of spinal surgery
- Known osteoporosis
- BMI ≥ 30
- Obstacles to performing radioscopy (primarily lateral), such as obesity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Distractor use for vertebrae separationDistractor 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 | Device | – |
Primary outcome
Device Reliability
Time frame: During the procedure
Assessed by positioning accuracy,holding capability and ease of use
10 secondary outcomes
Length of Procedure (hours)
Time frame: During the procedure
Major complications
Time frame: Intra and peri operative periods
Major complications
Time frame: 1 month
Hospital stay
Time frame: Assessed at Discharge, approximately 3 days
Minor complications
Time frame: 1 month
All cause mortality
Time frame: 1 month
Re operation
Time frame: 1 month
Re hospitalization
Time frame: 1 month
Device related SAE
Time frame: 1 month
All AEs
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2018.
- Derived from this study: PubMed 41164796Bornemann 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Pflugmacher, Prof principal investigator
University Hospital, Bonn
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Surgery, run by OrtoWay AB at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stan Mikulowski (46 8 558 093 69, stan.mikulowski@ortoway.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device Reliability (time frame: During the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03501810, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2018.