- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01989481
Predicting the Outcome of Total Knee Arthroplasty and Spinal Surgeon
March 23, 2015 updated by: Wei Tian, Beijing Jishuitan Hospital
Prospective Study of Risk Factors and Outcomes Following Total Knee Arthroplasty and Spinal Surgeon
The purpose of this observational study is to investigate the preoperative and operative factor of pain and functional outcome at one years following total knee arthroplasty and spinal surgeon.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
2000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Chengai Wu, Doctor
- Phone Number: +86-010-58516611
- Email: wuchengai05@163.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China
- Recruiting
- Beijing Hospital
-
Contact:
- Yaonan Zhang
- Email: xyn1126@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Inpatients; Patients have been diagnosed with osteoarthritis or disc degeneration disease.
Description
Inclusion Criteria:
- The patients have been waiting for surgery for treatment of osteoarthritis or disc degeneration disease.
- Must be between 18 and 65 years of age, of either sex.
- Must demonstrate willingness to participate in the study by signing the written informed consent.
Exclusion Criteria:
- Patients with Mandatory spondylitis, infections, neoplasms, inflammation, deformities, or previous surgery of spine or knee.
- The patient is participating in an interventional clinical trial or has in an interventional clinical trial within 30 days prior to enrollment.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change of functional score over time in the patients after operation
Time Frame: 3, 6, 12 months after surgery
|
3, 6, 12 months after surgery
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change of quality of life score over time in the patients after operation
Time Frame: 3, 6, 12 monthes after surgery
|
3, 6, 12 monthes after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Wei Tian, Doctor, BeiJing JiShuiTan Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2013
Primary Completion (Anticipated)
December 1, 2015
Study Registration Dates
First Submitted
November 11, 2013
First Submitted That Met QC Criteria
November 15, 2013
First Posted (Estimate)
November 21, 2013
Study Record Updates
Last Update Posted (Estimate)
March 24, 2015
Last Update Submitted That Met QC Criteria
March 23, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2012BAI10B02-OS
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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