Navigation-guided and 3D-imaging controlled minimally invasive posterior instrumentation in patients with pyogenic thoracolumbar spondylodiscitis
Organizational Data
- DRKS-ID:
- DRKS00010843
- Recruitment Status:
- Recruiting ongoing
- Date of registration in DRKS:
- 2016-08-15
- Last update in DRKS:
- 2019-01-02
- Registration type:
- Retrospective
Acronym/abbreviation of the study
Spondylodiscitis
URL of the study
No Entry
Brief summary in lay language
No Entry
Brief summary in scientific language
Pyogenic spondylodiscitis is an infectious disease of the spine with an incidence of around 1: 250.000. The disease can either be caused by a bacterial (such as Staphylococci, Salmonella, Neisseria, Brucella), mycotic, viral or a parasitic spread (usually haematogenic), or by a iatrogenic infection following previous operation. In many cases, however, the infectious agent cannot be detected (Spondylitis fungax). A pyogenic spondylodiscitis is present as soon as both, the intervertebral disc and the adjacent vertebral bodies, are affected by infectious formations, and it thus occurs mainly in the anterior parts of the spine. The course of spondylodiscitis is variable and can range from no clinical signs to sepsis or neurological deficits due to epidural abscesses. Bacterial invasion of the intervertebral disc and destruction of the adjacent bony structures frequently leads to pronounced local pain and immobilization of the patients. The treatment depends on factors such as localization of the infection, grade of osseous destruction, neurological deficits and general symptoms. A conservative treatment with antibiotic agents and immobilization for several weeks is traditionally recommended in the early stage of the disease. Indications for operative treatment are significant neurological deficits caused by compression of the spinal cord or the cauda equina, spinal instability, progressive bony destruction/ deformity, or progressive pain after conservative therapy. Furthermore, surgical treatment should also be considered in patients with therapy-refractory pain, particularly in elderly patients, since longer periods of immobilization can cause thromboembolic complications and muscle wasting. The optimal treatment of the patient should thus be minimally incriminating, effectively restore the stability of the spine, and allow for fast pain reduction and ambulation. A sole minimal invasive instrumentation of the thoracolumbar spine using a percutaneous/ transmuscular pedicle screw and rod system meets these criteria and might be an effective and safe alternative to the traditional invasive operation methods. The aim of this study is to show that a minimally invasive instrumentation can effectively restore the stability of the thoracolumbar spine and avoid kyphotic deformity. In combination with standard antibiotic treatment this surgical procedure should be sufficient to cure the infection.
Health condition or problem studied
- ICD10:
- M46.4 - Discitis, unspecified
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- We want to prospectively examine 25 patients, that we will operate with the described minimally invasive technique (A minimal invasive instrumentation of the thoracolumbar spine using a percutaneous/ transmuscular pedicle screw and rod system from behind). Perioperative laboratory and radiological data as well as intraoperative data will be collected during the hospital course. Pre- and postoperative clinical data collection will be supplemented by a questionnaire that incorporates the Charlson Comorbidity Index, the Oswestry Disability Index, the Visual Analogue Scale, and the EuroQol EQ-5D score. During follow-up visits at 6 weeks, 6 months, and 12 months clinical data will again be collected with help of the questionnaire, and the status of the instrumentation, the sagittal profile of the spine, as well as the formation of bridging bony spurs will be assessed by X-ray or CT scans, according to the standard of the respective study center.
Endpoints
- Primary outcome:
- Primary endpoint: Difference (vs. preoperative) Oswestry Disability Index (ODI) at 6 months
- Secondary outcome:
- Secondary endpoints: Pain and disability postoperative, at 6 weeks, 6 months, and 12 months (ODI; Visual Analogue Scale/ VAS; Macnab criteria), quality of life (EQ-5D-3L), time to mobilization, laboratory values (leukocytes, CRP), screw misplacement (Gertzbein/ Robbins), intra-/perioperative complications, reoperations, sagittal profile angles, formation of bridging bony spurs.
Study Design
- Purpose:
- Treatment
- Allocation:
- N/A (single arm study)
- Control:
-
- Uncontrolled/single arm
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Single (group)
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting ongoing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- University medical center Würzburg
- University medical center Universitätsklinikum Gießen und Marburg, Standort Gießen
- University medical center Mainz
- University medical center Freiburg im Breisgau
Recruitment period and number of participants
- Planned study start date:
- No Entry
- Actual study start date:
- 2016-04-19
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 50
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- Subjects with the indication for operative treatment of pyogenic thoracolumbar spondylodiscitis (minimally invasive posterior instrumentation +/- decompression +/- vertebral body biopsy; navigation-guidance/3D-imaging).
Exclusion Criteria
•Patient not suitable for anaesthesia •Treatment with any other (surgical or conservative) procedure •Incomplete data •No study consent
Addresses
Primary Sponsor
- Address:
- NeurochirurgiePD Dr. med. Karsten SchöllerKlinikstrasse 3335392 GiessenGermany
- Telephone:
- 0641-985-52900
- Fax:
- 0641/985-57169
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.ukgm.de/ugm_2/deu/ugi_nch/index.html
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- NeurochirurgiePD Dr. med. Karsten SchöllerKlinikstrasse 3335392 GiessenGermany
- Telephone:
- 0641-985-52900
- Fax:
- 0641/985-57169
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.ukgm.de/ugm_2/deu/ugi_nch/index.html
Contact for Public Queries
- Address:
- NeurochirurgieEnea ThanasiKlinikstrasse 3335392 GießenGermany
- Telephone:
- 0641-985-52900
- Fax:
- 0641/985-57169
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.ukgm.de/ugm_2/deu/ugi_nch/index.html
Principal Investigator
- Address:
- NeurochirurgiePD Dr. med. Karsten SchöllerKlinikstrasse 3335392 GiessenGermany
- Telephone:
- 0641-985-52900
- Fax:
- 0641/985-57169
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.ukgm.de/ugm_2/deu/ugi_nch/index.html
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Klinik für Neurochirurgie UKGM, Standort GießenKlinikstrsse 3335392 GießenGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission des Fachbereichs Medizin der Justus-Liebig-Universität GießenFrankfurter Straße 51-5335392 GießenGermany
- Telephone:
- +49-641-9942470
- Fax:
- +49-641-9942479
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2015-10-22
- Ethics committee number:
- 191/15
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2016-04-18
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No Entry
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- Studienprotokoll
- Background literature:
- Gatt ME, Paltiel O, Bursztyn M (2004) Is prolonged immobilization a risk factor for symptomatic venous thromboembolism in elderly bedridden patients? Results of a historical-cohort study. Thromb Haemost 91:538–543.
- Hadjipavlou AG, Mader JT, Necessary JT, Muffoletto AJ (2000) Hematogenous pyogenic spinal infections and their surgical management. Spine 25:1668–1679.
- McHenry MC, Easley KA, Locker GA (2002) Vertebral osteomyelitis: long-term outcome of 253 patients from 7 Cleveland area hospitals. Clin Infect Dis 34:1342–1350.
- Prandoni P, Villalta S, Tormene D, Spiezia L, Pesavento R (2007) Immobilization resulting from chronic medical diseases: a new risk factor for recurrent venous thromboembolism in anticoagulated patients. J Thromb Haemost 5:1786–1787.
- Safran O, Rand N, Kaplan L, Sagiv S, Floman Y (1998) Sequential or simultaneous, same-day anterior decompression and posterior stabilization in the management of vertebral osteomyelitis of the lumbar spine. Spine 23:1885–1890.
- Sapico FL, Montgomerie JZ (1979) Pyogenic vertebral osteomyelitis: report of nine cases and review of the literature. Rev Infect Dis 1:754–776.
- Wisneski RJ (1991) Infectious disease of the spine. Diagnostic and treatment considerations. Orthop Clin North Am 22:491–501.
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry