Osteoarthritis;NCT01989481
Predicting the Outcome of Total Knee Arthroplasty and Spinal Surgeon
An observational study of Osteoarthritis; and Intervertebral Disc Degeneration, run by Beijing Jishuitan Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Osteoarthritis;, Intervertebral Disc Degeneration
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- Nov 2013to Dec 2015
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Inpatients; Patients have been diagnosed with osteoarthritis or disc degeneration disease.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Hospital
Beijing, Beijing Municipality
Yaonan Zhang, xyn1126@163.com
About this study
Official title: 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.
- Conditions
- Osteoarthritis;, Intervertebral Disc Degeneration
- Medical subject headings
- Osteoarthritis, Intervertebral Disc Degeneration
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of functional score over time in the patients after operation
Measured: 3, 6, 12 months after surgery
Secondary outcomes (1)
Change of quality of life score over time in the patients after operation
Measured: 3, 6, 12 monthes after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis;Studies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Jishuitan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking Union Medical College Hospital, Peking University Third Hospital, Chinese PLA General Hospital, Beijing Hospital
- Responsible party
- Principal investigator, Wei Tian, Beijing Jishuitan Hospital
- Investigators
- Wei Tian, Doctor, Principal investigator, Beijing Jishuitan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01989481
- Sponsor's protocol ID
- 2012BAI10B02-OS
- Status last verified
- Mar 2015
- First submitted
- 11 Nov 2013
- Last updated
- 24 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Risk Factors and Outcomes Following Total Knee Arthroplasty and Spinal Surgeon
- ClinicalTrials.gov ID
- NCT01989481
- Acronym / sponsor ID
- 2012BAI10B02-OS
- Conditions
- Osteoarthritis;, Intervertebral Disc Degeneration
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Beijing Jishuitan HospitalUniversity, hospital or other
- Collaborators
- Peking Union Medical College Hospital, Peking University Third Hospital, Chinese PLA General Hospital, Beijing Hospital
- Study start
- Nov 2013
- Primary completion
- Dec 2015 (estimated)
- First posted
- 21 Nov 2013 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inpatients; Patients have been diagnosed with osteoarthritis or disc degeneration disease.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
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
Change of functional score over time in the patients after operation
Time frame: 3, 6, 12 months after surgery
1 secondary outcome
Change of quality of life score over time in the patients after operation
Time frame: 3, 6, 12 monthes after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2015.
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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.
Wei Tian, Doctor principal investigator
Beijing Jishuitan Hospital
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 Osteoarthritis; and Intervertebral Disc Degeneration, run by Beijing Jishuitan 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 24 Mar 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chengai Wu, Doctor (+86-010-58516611, wuchengai05@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of functional score over time in the patients after operation (time frame: 3, 6, 12 months after surgery). 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 24 Mar 2015.