Total Knee ReplacementNCT01037400
Biochemical Approach to Measuring Surgical Trauma
An observational study of Total Knee Replacement, run by Hamilton Health Sciences Corporation at 1 site in Canada.
Trial summary
This study will examine the magnitude and time course of changes in circulating (serum and plasma) biomarker concentrations associated with musculoskeletal injury created by total knee replacement surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Total Knee Replacement
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2010to Feb 2011
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Forty men and women ages 18-75 undergoing unilateral (n = 20) or bilateral (n = 20) knee replacement surgery with no musculoskeletal injury requiring medical attention in the past 3 months or producing pain in the previous 2 weeks and no inflammatory disease other than osteoarthritis.
Who may be able to join
- Age 18 to 75
- No musculoskeletal injury requiring medical attention in the past 3 months other than entirely related to worsening symptoms of the operative knee or spinal level.
- No musculoskeletal injury producing pain in the previous 2 weeks.
- No inflammatory disease other than osteoarthritis)
- No exercise with weights in the 2 weeks before surgery.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Further Development of a Biochemical Approach to Measuring Surgical Trauma to Musculoskeletal Tissues
This study will examine the magnitude and time course of changes in circulating (serum and plasma) biomarker concentrations associated with musculoskeletal injury created by total knee replacement surgery. The sensitivity to injury will be characterized by the changes in mean serum concentration before and after surgery. Specificity for the injured state will be evaluated comparing the baseline to peak change (injury response) with the pre-surgery to follow-up baseline fluctuation (i.e. measurement noise).
- Conditions
- Total Knee Replacement
- Keywords
- Knee Replacement, Arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Total Knee Replacement Patients | Forty men and women ages 18-75 undergoing unilateral (n = 20) or bilateral (n = 20) knee replacement surgery with no musculoskeletal injury requiring medical attention in the past 3 months or producing pain in the previous 2 weeks and no inflammatory disease other than osteoarthritis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and Specificity of biomarkers in response to tissue injury
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2009 (estimated)
- Study startFeb 2010
- Primary completionFeb 2011 (estimated)
Why it stopped: No patients recruited
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ReplacementStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anthony Adili, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01037400
- Sponsor's protocol ID
- TKR Study
- Status last verified
- Sep 2014
- First submitted
- 22 Dec 2009
- Last updated
- 17 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Further Development of a Biochemical Approach to Measuring Surgical Trauma to Musculoskeletal Tissues
- ClinicalTrials.gov ID
- NCT01037400
- Acronym / sponsor ID
- TKR Study
- Conditions
- Total Knee Replacement
- Keywords
- Knee Replacement, Arthroplasty
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No patients recruited
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Feb 2011 (estimated)
- First posted
- 23 Dec 2009 (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.
This study will examine the magnitude and time course of changes in circulating (serum and plasma) biomarker concentrations associated with musculoskeletal injury created by total knee replacement surgery. The sensitivity to injury will be characterized by the changes in mean serum concentration before and after surgery. Specificity for the injured state will be evaluated comparing the baseline to peak change (injury response) with the pre-surgery to follow-up baseline fluctuation (i.e. measurement noise).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Total Knee Replacement Patients | – | –Forty men and women ages 18-75 undergoing unilateral (n = 20) or bilateral (n = 20) knee replacement surgery with no musculoskeletal injury requiring medical attention in the past 3 months or producing pain in the previous 2 weeks and no inflammatory disease other than osteoarthritis. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Forty men and women ages 18-75 undergoing unilateral (n = 20) or bilateral (n = 20) knee replacement surgery with no musculoskeletal injury requiring medical attention in the past 3 months or producing pain in the previous 2 weeks and no inflammatory disease other than osteoarthritis.
Key inclusion criteria (5 listed)
- Age 18 to 75
- No musculoskeletal injury requiring medical attention in the past 3 months other than entirely related to worsening symptoms of the operative knee or spinal level.
- No musculoskeletal injury producing pain in the previous 2 weeks.
- No inflammatory disease other than osteoarthritis)
- No exercise with weights in the 2 weeks before surgery.
Key exclusion criteria (0 listed)
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
Sensitivity and Specificity of biomarkers in response to tissue injury
Time frame: 7 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Total Knee Replacement, run by Hamilton Health Sciences Corporation at 1 site in Canada.
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 5 inclusion and 0 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: withdrawn, as of the sponsor's last update on 17 Sep 2014. 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 Canada. 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 was withdrawn before enrolling participants, so there are no results.
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?
Sensitivity and Specificity of biomarkers in response to tissue injury (time frame: 7 days). 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 17 Sep 2014; AzTrials last refreshed its copy on 3 Nov 2026.