ArthritisNCT01545362
Effect of Preop Nutritional Status on Outcomes of Staged Bilateral Total Knee Arthroplasty
An observational study of Arthritis, run by Heekin Orthopedic Research Institute at 1 site in United States.
Trial summary
To determine if preop nutritional status is an indicator for outcomes of bilateral staged total knee arthroplasty. The investigators expect that patients having staged bilateral total knee arthroplasty with the second procedure performed within one week of the first and have a total lymphocyte count >1500 per cubic… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Arthritis
- What is being tested?
- Total knee arthroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Nov 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cohort selected from patients in orthopaedic clinic
Who may be able to join
- Patient is a male or non-pregnant female over the age of 21.
- Patient requires a bilateral staged knee arthroplasty (within 7 days)
- Patient has signed and dated an IRB approved consent form.
- Patient is able and willing to participate in the study according to the protocol for the full length of expected term of follow-up, and to follow their physician's directions.
- Patient has failed to respond to conservative treatment modalities.
Who cannot join
- Patient's bone stock is compromised by disease or infection, which cannot provide adequate support and/or fixation to the prosthesis.
- Patient is a prisoner.
- Surgery on the second side cancelled or delayed past 7 days by patient request subject will be terminated from the study.
- BMI >35
Trial locations and contacts
1 site in 1 country.
United States1 site
Heekin Orthopedic Specialists
Jacksonville, Florida, 32204
About this study
Official title: The Effect of Preop Nutritional Status on Outcomes of Staged Bilateral Total Knee Replacements Performed Within One Week
To determine if preop nutritional status is an indicator for outcomes of bilateral staged total knee arthroplasty. The investigators expect that patients having staged bilateral total knee arthroplasty with the second procedure performed within one week of the first and have a total lymphocyte count >1500 per cubic millimeter and serum albumin level >35 grams per liter will have the same or less complications and shorter length of stay than those with lower lymphocyte count and albumin level.
Read the detailed description
Association of malnutrition with postoperative complications after TKA has been reported in the form of increased rate of periprosthetic infection, longer hospital stay, etc. Reduced serum albumin and total lymphocyte count are commonly used to define malnutrition.
The goal was to evaluate the impact of the nutritional status on the outcomes of primary staged bilateral TKAs performed one-week apart during two separate hospitalizations.
Fifty consecutive patients with mean age of 67 years, mean BMI of 28.9 and 2.3 mean ASA score were followed for one year.
Prior to the first surgery 32% had a TLC <1500 cells/mm3 and 84% had a SA <3.5 g/dL. Before the second surgery 62% had a reduced TLC and all but one had a reduced SA.
Nine patients had a total of 12 perioperative blood transfusions (2 after the first surgery and 10 after the second surgery). The average length of stay was 3 days after each TKA.
None of the patients with the lowest TLC or SA before the first or the second stage had a revision.
Bilateral TKAs performed seven days apart in two separate hospitalizations is a safe and practical approach for qualified patients. The postoperative course was similar after each surgery. The preoperative nutritional status defined by TLC and SA did not influence the postoperative outcomes.
- Conditions
- Arthritis
- Being tested
- Total knee arthroplasty
- Medical subject headings
- Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total knee arthroplastyProcedure or surgery
Total knee arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| Staged bilateral total knee arthroplasty | Patients that have bilateral total knee arthroplasty staged within one week Receives: Procedure: Total knee arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood loss until drain is pulled
Measured: postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2012 (estimated)
- Study startNov 2011
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthritisStudies 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heekin Orthopedic Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, R. David Heekin, MD, Heekin Orthopedic Research Institute
- Investigators
- R. David Heekin, M.D., Principal investigator, Heekin Institute for Orthopedic Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01545362
- Sponsor's protocol ID
- 2010-004
- Status last verified
- Jan 2017
- First submitted
- 1 Mar 2012
- Last updated
- 12 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preop Nutritional Status on Outcomes of Staged Bilateral Total Knee Replacements Performed Within One Week
- ClinicalTrials.gov ID
- NCT01545362
- Acronym / sponsor ID
- 2010-004
- Conditions
- Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Heekin Orthopedic Research InstituteUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 6 Mar 2012 (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 if preop nutritional status is an indicator for outcomes of bilateral staged total knee arthroplasty. The investigators expect that patients having staged bilateral total knee arthroplasty with the second procedure performed within one week of the first and have a total lymphocyte count >1500 per cubic millimeter and serum albumin level >35 grams per liter will have the same or less complications and shorter length of stay than those with lower lymphocyte count and albumin level.
Detailed description
Association of malnutrition with postoperative complications after TKA has been reported in the form of increased rate of periprosthetic infection, longer hospital stay, etc. Reduced serum albumin and total lymphocyte count are commonly used to define malnutrition.
The goal was to evaluate the impact of the nutritional status on the outcomes of primary staged bilateral TKAs performed one-week apart during two separate hospitalizations.
Fifty consecutive patients with mean age of 67 years, mean BMI of 28.9 and 2.3 mean ASA score were followed for one year.
Prior to the first surgery 32% had a TLC <1500 cells/mm3 and 84% had a SA <3.5 g/dL. Before the second surgery 62% had a reduced TLC and all but one had a reduced SA.
Nine patients had a total of 12 perioperative blood transfusions (2 after the first surgery and 10 after the second surgery). The average length of stay was 3 days after each TKA.
None of the patients with the lowest TLC or SA before the first or the second stage had a revision.
Bilateral TKAs performed seven days apart in two separate hospitalizations is a safe and practical approach for qualified patients. The postoperative course was similar after each surgery. The preoperative nutritional status defined by TLC and SA did not influence the postoperative outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Staged bilateral total knee arthroplasty | – | Procedure: Total knee arthroplastyPatients that have bilateral total knee arthroplasty staged within one week |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cohort selected from patients in orthopaedic clinic
Key inclusion criteria (5 listed)
- Patient is a male or non-pregnant female over the age of 21.
- Patient requires a bilateral staged knee arthroplasty (within 7 days)
- Patient has signed and dated an IRB approved consent form.
- Patient is able and willing to participate in the study according to the protocol for the full length of expected term of follow-up, and to follow their physician's directions.
- Patient has failed to respond to conservative treatment modalities.
Key exclusion criteria (4 listed)
- Patient's bone stock is compromised by disease or infection, which cannot provide adequate support and/or fixation to the prosthesis.
- Patient is a prisoner.
- Surgery on the second side cancelled or delayed past 7 days by patient request subject will be terminated from the study.
- BMI >35
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 |
|---|---|---|
| Total knee arthroplastyTotal knee arthroplasty | Procedure or surgery | Staged bilateral total knee arthroplasty |
Primary outcome
Blood loss until drain is pulled
Time frame: postoperatively
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 12 Jan 2017.
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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.
R. David Heekin, M.D. principal investigator
Heekin Institute for Orthopedic Research
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 Arthritis, run by Heekin Orthopedic Research Institute at 1 site in United States.
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 4 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 12 Jan 2017. 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 United States. 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?
Blood loss until drain is pulled (time frame: postoperatively). 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 12 Jan 2017.