Necrosis of Femoral HeadNCT02063542
CSF Cholinergic Biomarkers and Postoperative Cognitive Change
An observational study of Necrosis of Femoral Head and Knee Osteoarthritis, run by RenJi Hospital at 1 site in China.
Trial summary
Previous study demonstrated that the condition of central cholinergic nerve is important for the postoperative cognitive dysfunction. In present study investigators hypothesized that the acetylcholine concentration in the cerebral spinal fluid is associated to the postoperative cognitive changes in aged patients… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Necrosis of Femoral Head, Knee Osteoarthritis, Fracture of Lower Limb
- How many people
- 102 participants
- Where
- 1 siteChina
- Study dates
- Jul 2014to Jul 2016
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Aged patients undergoing total knee replacement surgery.
Who may be able to join
- Elder than 60 years old
- Spoke proficient Mandarin Chinese
- Agree to undergoing spinal plus general anesthesia
- Selected total knee replacement surgery
Who cannot join
- Patients with neurological and/or psychiatric diseases, including AD, stroke and psychosis
- Have contraindication for spinal anesthesia such as clotting disorder local infection in the puncture site
- Existing cognitive impairment as evidenced by Mini-Mental State Examination scores below 24
- Several audition or vision disorder
- Unwillingness to comply with the protocol or procedures.
Trial locations and contacts
1 site in 1 country.
China1 site
Renji hospital, School of Medicine, Shanghai Jiaotong University
Shanghai, Shanghai Municipality, 200127
About this study
Official title: Cerebrospinal Fluid Cholinergic Biomarkers and Postoperative Cognitive Change in Aged Patients
Previous study demonstrated that the condition of central cholinergic nerve is important for the postoperative cognitive dysfunction. In present study investigators hypothesized that the acetylcholine concentration in the cerebral spinal fluid is associated to the postoperative cognitive changes in aged patients undergoing osteopathic surgery.
- Keywords
- Postoperative cognitive changes, Acetylcholine in CSF, Surgery
- Medical subject headings
- Osteoarthritis, Knee
What is being measured
The primary outcome is the main question the study is designed to answer.
Short-term postoperative cognitive dysfunction rate
Measured: The day before surgery and 7 days after surgery (or before leave hospital)
Concentration of Acetylcholine in CSF
Measured: During spinal anesthesia
Concentration of choline acetyltransferase in CSF
Measured: During spinal anesthesia
Concentration of acetylcholinesterase in CSF
Measured: During spinal anesthesia
Secondary outcomes (1)
Long-term postoperative cognitive dysfunction rate
Measured: Two months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2014 (estimated)
- Study startJul 2014
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Necrosis of Femoral HeadStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, diansan su, RenJi Hospital
- Investigators
- Diansan Su, Dr., Study chair, Renji Hospital, School of Medicine, Shanghai Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02063542
- Sponsor's protocol ID
- ACHandPOCD
- Status last verified
- May 2019
- First submitted
- 8 Feb 2014
- Last updated
- 22 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebrospinal Fluid Cholinergic Biomarkers and Postoperative Cognitive Change in Aged Patients
- ClinicalTrials.gov ID
- NCT02063542
- Acronym / sponsor ID
- ACHandPOCD
- Keywords
- Postoperative cognitive changes, Acetylcholine in CSF, Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- Jul 2014 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 14 Feb 2014 (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.
Previous study demonstrated that the condition of central cholinergic nerve is important for the postoperative cognitive dysfunction. In present study investigators hypothesized that the acetylcholine concentration in the cerebral spinal fluid is associated to the postoperative cognitive changes in aged patients undergoing osteopathic surgery.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Aged patients undergoing total knee replacement surgery.
Key inclusion criteria (4 listed)
- Elder than 60 years old
- Spoke proficient Mandarin Chinese
- Agree to undergoing spinal plus general anesthesia
- Selected total knee replacement surgery
Key exclusion criteria (5 listed)
- Patients with neurological and/or psychiatric diseases, including AD, stroke and psychosis
- Have contraindication for spinal anesthesia such as clotting disorder local infection in the puncture site
- Existing cognitive impairment as evidenced by Mini-Mental State Examination scores below 24
- Several audition or vision disorder
- Unwillingness to comply with the protocol or procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Short-term postoperative cognitive dysfunction rate
Time frame: The day before surgery and 7 days after surgery (or before leave hospital)
Concentration of Acetylcholine in CSF
Time frame: During spinal anesthesia
Concentration of choline acetyltransferase in CSF
Time frame: During spinal anesthesia
Concentration of acetylcholinesterase in CSF
Time frame: During spinal anesthesia
1 secondary outcome
Long-term postoperative cognitive dysfunction rate
Time frame: Two months after surgery
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 22 May 2019.
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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.
Diansan Su, Dr. study chair
Renji Hospital, School of Medicine, Shanghai Jiaotong University
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 Necrosis of Femoral Head and Knee Osteoarthritis, run by RenJi Hospital at 1 site in China.
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 4 inclusion and 5 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 22 May 2019. 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 China. 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?
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?
Short-term postoperative cognitive dysfunction rate (time frame: The day before surgery and 7 days after surgery (or before leave hospital)). The study lists 4 primary outcomes in all. 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 22 May 2019.