Degenerative Disc DiseaseNCT01513577
Percutaneous Minimal Invasive Pedicular Screw and Rod Insertion in Circumferential Lumbar Fusion
A study testing Pedicle screws and Percutaneous stab incisions in people with Degenerative Disc Disease, run by Northern Orthopaedic Division, Denmark.
Trial summary
Convalescence after lumbar surgery is dependent on the extensiveness of the surgical procedure. Minimal invasive techniques in lumbar spine surgery are reported to achieve excellent clinical results with less pain, morbidity and disability. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degenerative Disc Disease
- What is being tested?
- Pedicle screws and Percutaneous stab incisions
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Jan 2003to Jun 2006
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Degenerative disc disease in one of the three lower lumbar levels.
Who cannot join
- Previous fusion, metabolic bone disease, co-morbidity or psychological instability.
About this study
Official title: Percutaneous Minimal Invasive Pedicular Screw and Rod Insertion Reduces Hospital Stay and Morbidity Compared to Open Midline Approach in Circumferential Lumbar Fusion. A Randomized Study With 2 Years Follow-up
Convalescence after lumbar surgery is dependent on the extensiveness of the surgical procedure. Minimal invasive techniques in lumbar spine surgery are reported to achieve excellent clinical results with less pain, morbidity and disability.
Read the detailed description
To achieve lumbar fusion when there is no need for decompression of the neural structures a posterior midline approach and a left anterior retroperitoneal approach is used. The retroperitoneal anterior approach to the lumbar spine offers some benefits compared with the posterior approach. Dural injury and epidural scarring can be avoided, and an interbody fusion graft can be placed with minimal risk to the nerve roots. However, the extensive posterior midline approach with extensive muscle dissection is necessary to place the pedicular screws.
A report of a follow-up period of 2 years of a randomized trial of minimal invasive insertion of pedicular screws and rods in lumbar fusion.
- Conditions
- Degenerative Disc Disease
- Being tested
- Pedicle screws, Percutaneous stab incisions
- Keywords
- Lumbar fusion, Pedicular screws, Minimal invasive technique, Randomized controlled trial
- Medical subject headings
- Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pedicle screwsOther
The control group received posterior fixation with pedicle screws through a midline approach. Through the approach bone was harvested from the right posterior iliac crest. Before closure of the posterior approach an epidural catheter and a drain was placed.
Percutaneous stab incisionsOther
The intervention group received posterior fixation through 6 percutaneous stab incisions with the use of the sextant system. Through a separate 3-4 cm long incision, bone was harvested from the right posterior iliac crest. After decorticating the transverse processes through the stab wounds, the bone graft was placed with a 10 ml cut syringe. An epidural catheter was placed at the end of the posterior procedure.
| Study group | Role | What they receive |
|---|---|---|
| Minimal invasive pedicular screw | Experimental | Not described Receives: Other: Pedicle screws |
| Standard open insertion | Experimental | Not described Receives: Other: Percutaneous stab incisions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percutaneous technique versus conventional open technique.
The investigators want to assess the effects of percutaneous posterior technique versus conventional open posterior technique on post-fusion pain, mobilization, convalescence, disability and bony fusion in 360 degree lumbar fusion.
Measured: Two years
Secondary outcomes (1)
Improvements of recovery and convalescence.
To investigate operative time, blood loss, use of analgesic, days until ambulation without aids, hospitalization, Oswestry Disability Index.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2012 (estimated)
- Study startJan 2003
- Primary completionDec 2004
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Disc DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northern Orthopaedic Division, Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sten Rasmussen, M.D., Principal investigator, Orthopaedic Surgery Research Unit, Aalborg University Hospital, DenmarkHenrik Kehlet, M.D., Study chair, Department of Orthopaedic Surgery, Vejle and Give Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01513577
- Sponsor's protocol ID
- ON-07-009-RAS
- Status last verified
- Sep 2014
- First submitted
- 14 Dec 2011
- Last updated
- 15 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Minimal Invasive Pedicular Screw and Rod Insertion Reduces Hospital Stay and Morbidity Compared to Open Midline Approach in Circumferential Lumbar Fusion. A Randomized Study With 2 Years Follow-up
- ClinicalTrials.gov ID
- NCT01513577
- Acronym / sponsor ID
- ON-07-009-RAS
- Conditions
- Degenerative Disc Disease
- Keywords
- Lumbar fusion, Pedicular screws, Minimal invasive technique, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Northern Orthopaedic Division, DenmarkUniversity, hospital or other
- Study start
- Jan 2003
- Primary completion
- Dec 2004 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 20 Jan 2012 (estimated)
- 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.
Convalescence after lumbar surgery is dependent on the extensiveness of the surgical procedure. Minimal invasive techniques in lumbar spine surgery are reported to achieve excellent clinical results with less pain, morbidity and disability.
Detailed description
To achieve lumbar fusion when there is no need for decompression of the neural structures a posterior midline approach and a left anterior retroperitoneal approach is used. The retroperitoneal anterior approach to the lumbar spine offers some benefits compared with the posterior approach. Dural injury and epidural scarring can be avoided, and an interbody fusion graft can be placed with minimal risk to the nerve roots. However, the extensive posterior midline approach with extensive muscle dissection is necessary to place the pedicular screws.
A report of a follow-up period of 2 years of a randomized trial of minimal invasive insertion of pedicular screws and rods in lumbar fusion.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minimal invasive pedicular screw | Experimental | Other: Pedicle screws |
| Standard open insertion | Experimental | Other: Percutaneous stab incisions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Degenerative disc disease in one of the three lower lumbar levels.
Key exclusion criteria (1 listed)
- Previous fusion, metabolic bone disease, co-morbidity or psychological instability.
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 |
|---|---|---|
| Pedicle screwsThe control group received posterior fixation with pedicle screws through a midline approach. Through the approach bone was harvested from the right posterior iliac crest. Before closure of the posterior approach an epidural catheter and a drain was placed. | Other | Minimal invasive pedicular screw |
| Percutaneous stab incisionsThe intervention group received posterior fixation through 6 percutaneous stab incisions with the use of the sextant system. Through a separate 3-4 cm long incision, bone was harvested from the right posterior iliac crest. After decorticating the transverse processes through the stab wounds, the bone graft was placed with a 10 ml cut syringe. An epidural catheter was placed at the end of the posterior procedure. | Other | Standard open insertion |
Primary outcome
Percutaneous technique versus conventional open technique.
Time frame: Two years
The investigators want to assess the effects of percutaneous posterior technique versus conventional open posterior technique on post-fusion pain, mobilization, convalescence, disability and bony fusion in 360 degree lumbar fusion.
1 secondary outcome
Improvements of recovery and convalescence.
Time frame: Two years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2014.
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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.
Sten Rasmussen, M.D. principal investigator
Orthopaedic Surgery Research Unit, Aalborg University Hospital, Denmark
Henrik Kehlet, M.D. study chair
Department of Orthopaedic Surgery, Vejle and Give Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Pedicle screws and Percutaneous stab incisions in people with Degenerative Disc Disease, run by Northern Orthopaedic Division, Denmark.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 15 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percutaneous technique versus conventional open technique. (time frame: Two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Sep 2014.