Minimally invasive transforaminal lumbar interbody fusion (MIS TLIF): perioperative and postoperative complications in patients aged 80 and older
Organizational Data
- DRKS-ID:
- DRKS00007997
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2015-04-08
- Last update in DRKS:
- 2020-10-19
- Registration type:
- Retrospective
Acronym/abbreviation of the study
No Entry
URL of the study
No Entry
Brief summary in lay language
As part of a stabilization of the lumbar spine, screws are introduced through a bony bridge (pedicle) into the vertebral body; furthermore, a spacer (cage) is introduced into the intervertebral disc space to ensure sufficient stability in spinal segments with instability or degenerative disease. The minimally invasive technique called transforaminal lumbar interbody fusion (MIS TLIF) offers advantages compared to the open technique such as smaller incisions, less muscle trauma, less frequent wound complications, less blood loss during surgery, earlier mobilization and earlier discharge from hospital. For this surgical technique, the evidence regarding the perioperative and postoperative complications in older patients is very limited. Available studies stated no significantly increased risk in patients over 65 or 70 years. The proportion of patients with an age of at least 80 years, however, was low in these studies. Data regarding the perioperative and postoperative complications after MIS TLIF for patients with an age of at least 80 years is not available. The aim of this research project is the retrospective investigation of perioperative and postoperative complications in patients with an age of at least 80 years after lumbar interbody fusion minimally invasive (MIS TLIF).
Brief summary in scientific language
As part of a stabilization of the lumbar spine, transpedicular screws are introduced into the vertebral body, and a cage is introduced into the intervertebral disc space to ensure sufficient stability in spinal segments with instability or degenerative disease. The minimally invasive technique called transforaminal lumbar interbody fusion (MIS TLIF) offers advantages compared to the open technique such as smaller incisions, less muscle trauma, less frequent wound complications, less blood loss during surgery, earlier mobilization and earlier discharge from hospital. For this surgical technique, the evidence regarding the perioperative and postoperative complications in older patients is very limited. Available studies stated no significantly increased risk in patients over 65 or 70 years. The proportion of patients with an age of at least 80 years, however, was low in these studies. Data regarding the perioperative and postoperative complications after MIS TLIF for patients with an age of at least 80 years is not available. The aim of this research project is the retrospective investigation of perioperative and postoperative complications in patients with an age of at least 80 years after lumbar interbody fusion minimally invasive (MIS TLIF).
Health condition or problem studied
- ICD10:
- M53.26
- ICD10:
- M43.16
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- Assessment of perioperative and postoperative complications in patients ≥ 80 years who underwent MIS TLIF between March 2009 and February 2014 due to lumbar instability or degeneration.
Endpoints
- Primary outcome:
- Occurrence of major complications within 30 days of MIS TLIF: death, myocardial infarction, stroke, pulmonary embolism, severe pneumonia / mechanical ventilation, reoperation, new motor deficit grade ≤ 3/5.
- Secondary outcome:
- Occurrence of minor complications within 30 days of MIS TLIF: new motor deficit grade > 3/5, slight pneumonia / transient dependency on oxygen, postoperative confusion, urinary tract infection, anemia requiring transfusion, deep vein thrombosis, intraoperative durotomy, hepatic impairment, depressive episode, sacroiliac joint syndrome.
Study Design
- Purpose:
- Treatment
- Retrospective/prospective:
- No Entry
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center Klinik für Neurochirurgie Freiburg im Breisgau
Recruitment period and number of participants
- Planned study start date:
- No Entry
- Actual study start date:
- 2015-04-06
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2016-07-15
- Target Sample Size:
- 20
- Final Sample Size:
- 21
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 80 Years
- Maximum Age:
- 90 Years
- Additional Inclusion Criteria:
- Patients ≥ 80 years who underwent MIS TLIF between March 2009 and February 2014 due to lumbar instability or degeneration.
Exclusion Criteria
Patient age < 80 years. MIS TLIF due to infection or trauma.
Addresses
Primary Sponsor
- Address:
- Universitätsklinikum FreiburgHugstetter Strasse 4979095 FreiburgGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uniklinik-freiburg.de
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Neurochirurgische Universitätsklinik FreiburgDr. med. Jan-Helge KlinglerBreisacher Str. 6479106 FreiburgGermany
- Telephone:
- +49 761 270 50010
- Fax:
- +49 761 270 50080
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uniklinik-freiburg.de/neurochirurgie/live/index.html
Contact for Public Queries
- Address:
- Neurochirurgische Universitätsklinik FreiburgDr. med. Jan-Helge KlinglerBreisacher Str. 6479106 FreiburgGermany
- Telephone:
- +49 761 270 50010
- Fax:
- +49 761 270 50080
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uniklinik-freiburg.de/neurochirurgie/live/index.html
Principal Investigator
- Address:
- Neurochirurgische Universitätsklinik FreiburgDr. med. Jan-Helge KlinglerBreisacher Str. 6479106 FreiburgGermany
- Telephone:
- +49 761 270 50010
- Fax:
- +49 761 270 50080
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uniklinik-freiburg.de/neurochirurgie/live/index.html
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Klinik für NeurochirurgieBreisacher Str. 6479106 FreiburgGermany
- Telephone:
- 0761 270 50010
- Fax:
- 0761 270 50080
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uniklinik-freiburg.de/neurochirurgie.html
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission der Albert-Ludwigs-Universität FreiburgEngelberger Str. 2179106 FreiburgGermany
- Telephone:
- +49-761-27072600
- Fax:
- +49-761-27072630
- 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:
- 2015-03-16
- Ethics committee number:
- 128/15
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2015-03-26
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:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- PubMed - Abstract
- 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