Knee SurgeryCASNCT02435251
Changes in Anthropometry Following Ambulatory Orthopaedic Surgery
An observational study of Knee Surgery and Shoulder Surgery, run by State University of New York at Buffalo at 1 site in United States.
Trial summary
The purpose of this research is to study changes in weight, body mass index, and percentage of fat following orthopaedic knee or shoulder surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Knee Surgery, Shoulder Surgery
- What is being tested?
- dual energy X-ray absorptiometry
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Apr 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are scheduled to undergo ambulatory orthopaedic surgery at our institution.
Who may be able to join
- 18-70 years-old
- scheduled to undergo knee or shoulder ambulatory surgery
Who cannot join
- weighs greater than 350 pounds
- pregnancy
- history of bariatric surgery
- dieting or engaged in a weight loss program
- taking weight loss supplements
- undergoing other types of surgery during study period
Trial locations and contacts
1 site in 1 country.
United States1 site
UBMD Orthopaedics & Sports Medicine
Amherst, New York, 14226
About this study
The purpose of this research is to study changes in weight, body mass index, and percentage of fat following orthopaedic knee or shoulder surgery.
- Conditions
- Knee Surgery, Shoulder Surgery
- Being tested
- dual energy X-ray absorptiometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dual energy X-ray absorptiometryDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Fat mass
Measured: 6-weeks after surgery
Secondary outcomes (3)
Lean mass
Measured: 6-weeks after surgery
Weight
Measured: 6-weeks after surgery
Body mass index
Measured: 6-weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2015 (estimated)
- Study startJan 2014
- Primary completionApr 2016
- Study completionApr 2016
Why it stopped: study was no longer feasible
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee SurgeryStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leslie Bisson, State University of New York at Buffalo
- Investigators
- Leslie Bisson, MD, Principal investigator, University at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02435251
- Sponsor's protocol ID
- 458943-7
- Acronym
- CAS
- Status last verified
- Oct 2019
- First submitted
- 27 Apr 2015
- Last updated
- 23 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Anthropometry Following Ambulatory Orthopaedic Surgery
- ClinicalTrials.gov ID
- NCT02435251
- Acronym / sponsor ID
- CAS / 458943-7
- Conditions
- Knee Surgery, Shoulder Surgery
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: study was no longer feasible
- Enrolment
- 0 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 6 May 2015 (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 research is to study changes in weight, body mass index, and percentage of fat following orthopaedic knee or shoulder surgery.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are scheduled to undergo ambulatory orthopaedic surgery at our institution.
Key inclusion criteria (2 listed)
- 18-70 years-old
- scheduled to undergo knee or shoulder ambulatory surgery
Key exclusion criteria (6 listed)
- weighs greater than 350 pounds
- pregnancy
- history of bariatric surgery
- dieting or engaged in a weight loss program
- taking weight loss supplements
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 |
|---|---|---|
| dual energy X-ray absorptiometry | Device | – |
Primary outcome
Fat mass
Time frame: 6-weeks after surgery
3 secondary outcomes
Lean mass
Time frame: 6-weeks after surgery
Weight
Time frame: 6-weeks after surgery
Body mass index
Time frame: 6-weeks after surgery
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 23 Oct 2019.
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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.
Leslie Bisson, MD principal investigator
University at Buffalo
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 Knee Surgery and Shoulder Surgery, run by State University of New York at Buffalo 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 2 inclusion and 6 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 23 Oct 2019. 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 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?
Fat mass (time frame: 6-weeks 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 23 Oct 2019; AzTrials last refreshed its copy on 30 Oct 2026.