Total Knee ArthroplastyNCT00999570
High Volume Specialty Knee Replacement Surgeons Achieve Better Clinical and Quality-of-Life Scores
An observational study of Total Knee Arthroplasty, run by Singapore General Hospital at 1 site in Singapore.
Trial summary
To determine whether specialty training or high volume of operative experience is associated with better clinical outcome and quality-of-life scores. Read more about this study
- Who is it for?
- Ages 37 to 90 years
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- Specialty training for knee surgeons
- How many people
- 3,458 participants
- Where
- 1 siteSingapore
- Study dates
- Jan 2004to Dec 2007
- 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 37 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients seen at Singapore General Hospital who require total knee arthroplasty
Who may be able to join
- patients who require total knee arthroplasty seen during the specified period
Who cannot join
- revision total knee arthroplasty
- unicompartmental or bicompartmental knee arthroplasty
Trial locations and contacts
1 site in 1 country.
About this study
To determine whether specialty training or high volume of operative experience is associated with better clinical outcome and quality-of-life scores.
Read the detailed description
Primary total knee replacements are becoming a commonly performed procedure. Many general orthopaedists can perform large numbers of such surgeries. Thus, we aim to find out if there is value of having surgeons with AR fellowship training to perform primary total knee arthroplasty. This has an implication in the direction of the training of future AR surgeons and in the distribution of operative cases.
- Conditions
- Total Knee Arthroplasty
- Being tested
- Specialty training for knee surgeons
- Keywords
- outcome, quality of life, total knee arthroplasty, clinical outcome scores post total knee arthroplasty, quality of life scores post total knee arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specialty training for knee surgeonsOther
| Study group | Role | What they receive |
|---|---|---|
| Patients operated by AR trained surgeons | patients who had their total knee replacements performed by surgeons who have completed a fellowship training in adult reconstruction surgery Receives: Other: Specialty training for knee surgeons | |
| Patients operated by non-AR surgeons | patients who had their total knee replacements performed by orthopaedic surgeons who did not complete an adult reconstruction fellowship training |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine whether specialty training or high volume of operative experience is associated with better clinical outcome and quality-of-life scores.
Measured: 2 years
Secondary outcomes (1)
To determine which other factors are predictors of better outcome score and quality-of-life scores.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2009 (estimated)
- Study startJan 2004
- Primary completionMay 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- More trials run by Singapore General 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-control
- Time perspective
- Prospective
- Enrolment
- 3,458 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Sok Chuen Tan, MBBS, MRCS, Principal investigator, Singapore General HospitalSeng Jin Yeo, FRCS, FAMS, Study director, Singapore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00999570
- Sponsor's protocol ID
- 2009/626/D
- Status last verified
- Oct 2009
- First submitted
- 20 Oct 2009
- Last updated
- 22 Oct 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Katz JN, Mahomed NN, Baron JA, Barrett JA, Fossel AH, Creel AH, Wright J, Wright EA, Losina E. Association of hospital and surgeon procedure volume with patient-centered outcomes of total knee replacement in a population-based cohort of patients age 65 years and older. Arthritis Rheum. 2007 Feb;56(2):568-74. doi: 10.1002/art.22333.
PubMed 17265491
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Volume Specialty Knee Replacement Surgeons Achieve Better Clinical and Quality-of-Life Scores
- ClinicalTrials.gov ID
- NCT00999570
- Acronym / sponsor ID
- 2009/626/D
- Conditions
- Total Knee Arthroplasty
- Keywords
- outcome, quality of life, total knee arthroplasty, clinical outcome scores post total knee arthroplasty, quality of life scores post total knee arthroplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,458 participants (actual)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Study start
- Jan 2004
- Primary completion
- May 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 22 Oct 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.
To determine whether specialty training or high volume of operative experience is associated with better clinical outcome and quality-of-life scores.
Detailed description
Primary total knee replacements are becoming a commonly performed procedure. Many general orthopaedists can perform large numbers of such surgeries. Thus, we aim to find out if there is value of having surgeons with AR fellowship training to perform primary total knee arthroplasty. This has an implication in the direction of the training of future AR surgeons and in the distribution of operative cases.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients operated by AR trained surgeons | – | Other: Specialty training for knee surgeonspatients who had their total knee replacements performed by surgeons who have completed a fellowship training in adult reconstruction surgery |
| Patients operated by non-AR surgeons | – | –patients who had their total knee replacements performed by orthopaedic surgeons who did not complete an adult reconstruction fellowship training |
Who may qualify
- Ages
- 37 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients seen at Singapore General Hospital who require total knee arthroplasty
Key inclusion criteria (1 listed)
- patients who require total knee arthroplasty seen during the specified period
Key exclusion criteria (2 listed)
- revision total knee arthroplasty
- unicompartmental or bicompartmental knee arthroplasty
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Specialty training for knee surgeons | Other | Patients operated by AR trained surgeons |
Primary outcome
To determine whether specialty training or high volume of operative experience is associated with better clinical outcome and quality-of-life scores.
Time frame: 2 years
1 secondary outcome
To determine which other factors are predictors of better outcome score and quality-of-life scores.
Time frame: 2 years
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 Oct 2009.
- Background: PubMed 17265491Katz JN, Mahomed NN, Baron JA, Barrett JA, Fossel AH, Creel AH, Wright J, Wright EA, Losina E. Association of hospital and surgeon procedure volume with patient-centered outcomes of total knee replacement in a population-based cohort of patients age 65 years and older. Arthritis Rheum. 2007 Feb;56(2):568-74. doi: 10.1002/art.22333.
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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.
Sok Chuen Tan, MBBS, MRCS principal investigator
Singapore General Hospital
Seng Jin Yeo, FRCS, FAMS study director
Singapore General 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 Total Knee Arthroplasty, run by Singapore General Hospital at 1 site in Singapore.
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 1 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: finished, as of the sponsor's last update on 22 Oct 2009. 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 Singapore. 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?
To determine whether specialty training or high volume of operative experience is associated with better clinical outcome and quality-of-life scores. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00999570, which also lists 1 linked publication.
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 Oct 2009.