Surgical Procedure, Unspecified Clinical Trial
Official title:
Conservative Versus Surgical Treatment of Native Vertebral Osteomyelitis: a Randomized Multicentre Trial
Verified date | June 2020 |
Source | Charite University, Berlin, Germany |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The optimal treatment of uncomplicated native vertebral osteomyelitis (NVO) is unknown. While
some authors recommend surgical treatment (consisting of spinal debridement, decompression
and instrumentation using hardware implantation of hardware), others recommend conservative
treatment (with antimicrobial therapy alone). In the proposed randomized controlled
multicentric trial, we plan to compare the outcome of conservative vs, surgical treatment of
NVO regarding (i) infection outcome (i.e. infection-free proportion of subjects), (ii)
functional outcome (pain intensity, spine scores, general mobility, quality of life
evaluation), and (iii) socioeconomic impact (direct and indirect costs due to NVO).
A total of 350 subjects will be screened, 300 subjects will be randomized 1:1 into 2 arms:
experimental (surgical treatment) and control (conservative treatment). Subjects in both
groups will receive pathogen-directed antimicrobial therapy for 6 weeks. Excluded will be
patients with acute neurologic impairment, extensive bone destruction, epidural/intraspinal
abscess and with spinal hardware.
The clinical impact of this study is enormous since it will generate evidence for rational
treatment guidelines. We hypothesize that the conservative treatment of uncomplicated NVO is
non-inferior to surgical therapy regarding infection outcome. If the conservative treatment
of NVO demonstrate non-inferiority, patients may benefit from avoiding unnecessary surgical
intervention.
Status | Not yet recruiting |
Enrollment | 300 |
Est. completion date | July 1, 2022 |
Est. primary completion date | July 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Subjects aged =18 years with NVO, diagnosed by microbiology (positive blood culture or vertebral tissue culture) or histopathology. - Subjects are willing to participate in the study (signed informed consent) and comply with planned follow-up assessments at 3, 6 and 12 months). Exclusion Criteria: - Infection due to Mycobacterium spp. or Brucella spp. - Infection associated with spinal hardware - Acute neurologic impairment - Extensive defect of vertebral body (>2 cm) - Extensive epidural abscess (>1 cm) or intraspinal abscess (any size) - Spinal instability/deformity requiring immediate stabilisation |
Country | Name | City | State |
---|---|---|---|
Germany | Charité Universitätsmedizin Berlin | Berlin |
Lead Sponsor | Collaborator |
---|---|
Charite University, Berlin, Germany |
Germany,
Berbari EF, Kanj SS, Kowalski TJ, Darouiche RO, Widmer AF, Schmitt SK, Hendershot EF, Holtom PD, Huddleston PM 3rd, Petermann GW, Osmon DR. Executive Summary: 2015 Infectious Diseases Society of America (IDSA) Clinical Practice Guidelines for the Diagnosi — View Citation
Bernard L, Dinh A, Ghout I, Simo D, Zeller V, Issartel B, Le Moing V, Belmatoug N, Lesprit P, Bru JP, Therby A, Bouhour D, Dénes E, Debard A, Chirouze C, Fèvre K, Dupon M, Aegerter P, Mulleman D; Duration of Treatment for Spondylodiscitis (DTS) study grou — View Citation
Murillo O, Grau I, Lora-Tamayo J, Gomez-Junyent J, Ribera A, Tubau F, Ariza J, Pallares R. The changing epidemiology of bacteraemic osteoarticular infections in the early 21st century. Clin Microbiol Infect. 2015 Mar;21(3):254.e1-8. doi: 10.1016/j.cmi.201 — View Citation
Rutges JP, Kempen DH, van Dijk M, Oner FC. Outcome of conservative and surgical treatment of pyogenic spondylodiscitis: a systematic literature review. Eur Spine J. 2016 Apr;25(4):983-99. doi: 10.1007/s00586-015-4318-y. Epub 2015 Nov 19. Review. — View Citation
Shiban E, Janssen I, Wostrack M, Krieg SM, Ringel F, Meyer B, Stoffel M. A retrospective study of 113 consecutive cases of surgically treated spondylodiscitis patients. A single-center experience. Acta Neurochir (Wien). 2014 Jun;156(6):1189-96. doi: 10.10 — View Citation
Valancius K, Hansen ES, Høy K, Helmig P, Niedermann B, Bünger C. Failure modes in conservative and surgical management of infectious spondylodiscitis. Eur Spine J. 2013 Aug;22(8):1837-44. doi: 10.1007/s00586-012-2614-3. Epub 2012 Dec 18. — View Citation
Zimmerli W. Clinical practice. Vertebral osteomyelitis. N Engl J Med. 2010 Mar 18;362(11):1022-9. doi: 10.1056/NEJMcp0910753. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of infection-free subjects | Treatment success: Infection-free status defined as (i) absence of clinical signs of native vertebral osteomyelitis (fever, local signs at surgical site), (ii) normal laboratory findings (serum C-reactive protein), (iii) absence of radiological signs of active native vertebral osteomyelitis (progressive bone destruction, implant loosening or migration), and (iv) absence of unplanned surgical interventions or additional antimicrobial treatment. Confirmed failure: Persistence or relapse of infection due to the same pathogen. Possible failure: Subjects not fulfilling the criteria for treatment success but have no diagnosis of persistence or relapse of native vertebral osteomyelitis |
12 months after treatment initiation | |
Secondary | Functional outcome regarding pain intensity | Pain intensity according to the numerical rating scale (NRS) for the indication of the perceived pain. Values are from 0 (no pain) to 10 (greatest pain imaginable) | 12 months after treatment initiation | |
Secondary | Functional outcome regarding mobility according to Nurick scale | Nurick scale: A six grade system (0-5) based on the difficulty in walking: Grade 0: signs or symptoms of root involvement but without evidence of spinal cord disease Grade 1: signs of spinal cord disease but no difficulty in walking. Grade 2: slight difficulty in walking which does not prevent full-time employment Grade 3: difficulty in walking which prevented full time employment or the ability to do all housework, but which was not so severe as to require someone else's help to walk Grade 4: able to walk only with someone else's help or with the aid of a frame. Grade 5 : chairbound or bedridden. |
12 months after treatment initiation | |
Secondary | Functional outcome regarding mobility according Oswestry Disability Index | The Oswestry Disability Index (ODI) will be used in patients with low back pain. There are 10 questions to evaluate how the back or leg pain is affecting the patient's ability to manage in everyday life. Scoring Method Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. The obtained score can be multiplied by 2 to produce a percentage score. Interpretation 0%-20%: Minimal disability 20%-40% Moderate disability 40%-60%: Severe disability 60%-80%: Crippled 80%-100%: These patients are either bed-bound or exaggerating their symptoms |
12 months after treatment initiation | |
Secondary | Functional outcome regarding quality of life using EuroQOL score | EuroQOL questionnaire is a measure of both clinical and economic value in health care. It consists of a descriptive system and a visual analogue scale (EQ VAS). The descriptive system has 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The visual analogue scale has 3 levels of severity (no problems, some problems, extreme problems). |
12 months after treatment initiation | |
Secondary | Functional outcome regarding quality of life using SF-36 questionnaire | The questionnaire is composed of 36 questions organized in eight scales: physical functioning, role limitations due to physical health problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and general mental health. Respondents rate each activity on a three-level scale (a lot, a little, not at all). Item responses are then summed with results expressed on a scale ranging from 0 to 100, representing higher values a better function. |
12 months after treatment initiation |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04061629 -
Minimal Occlusive Pressure With Cuffed ETTs: The Effect of 3 Different Sizes of cETT on Intracuff Pressure in Children
|
||
Completed |
NCT03299920 -
Opioid Consumption After Knee Arthroscopy
|
N/A | |
Not yet recruiting |
NCT03213548 -
Aesthetic and Functional Results of Alar Base Modifications in Rhinoplasty
|
N/A | |
Completed |
NCT06164158 -
Role of Procedural Videos in Teaching the Surgery Residents
|
N/A | |
Recruiting |
NCT03854669 -
Experimental Pain Reporting Accuracy and Clinical Post-operative Pain
|
N/A | |
Active, not recruiting |
NCT03776591 -
Open D3 Right Hemicolectomy Compared to Laparoscopic CME for Right Sided Colon Cancer
|
N/A | |
Completed |
NCT04332679 -
Non-resorbable Membranes Versus Titanium Meshes and Resorbable Membranes
|
N/A | |
Completed |
NCT03305666 -
Trial of Injected Liposomal Bupivacaine vs Bupivacaine Infusion After Surgical Stabilization of Rib Fractures
|
Phase 4 | |
Completed |
NCT05008107 -
Virtual Reality as a Perioperative Teaching Tool for Families
|
N/A | |
Terminated |
NCT02399111 -
A Trial to Evaluate Negative Pressure Incision Management System for Groin Wounds in Vascular Surgery Patients
|
N/A | |
Terminated |
NCT00753766 -
Multifactorial Pre-operative Intervention in Diabetes Mellitus
|
N/A | |
Active, not recruiting |
NCT03684720 -
Using 'Guided-Discovery-Learning' to Optimize and Maximize Transfer of Surgical Simulation
|
N/A | |
Recruiting |
NCT04134975 -
Evaluation of the Contribution of Intraoperative Scans Coupled With the Navigation for the Precision of the Positioning of the Pedicle Screws During a Lumbar Spine Surgery: a Prospective Randomised Study
|
N/A | |
Completed |
NCT06148701 -
Preoperative Anesthesia Automatic System:a Retrospective Cohort Study
|
||
Active, not recruiting |
NCT04202874 -
A Trial Comparing Surgeon-administered TAP Block With Placebo After Midline Laparotomy in Gynecologic Oncology
|
Phase 3 | |
Completed |
NCT05428579 -
Status of Surgical Resection and Histologic Subtype as Predictors of Local Recurrence in Retroperitoneal Liposarcoma
|
||
Completed |
NCT02626546 -
Predictors, Risk Factors and Outcome Following Major Surgery
|
||
Recruiting |
NCT06278610 -
Pelvic Exenteration and Laterally Extended Pelvic Resection
|
||
Recruiting |
NCT05044832 -
Decreasing Emergence Agitation With Personalized Music
|
N/A | |
Completed |
NCT04327895 -
Surgery in Context of Terrorist Attack : a Survey of French Surgeons
|