Post-operative ComplicationsNCT07063784
Patient Positioning for Hand, Wrist, and Elbow Surgery: Stretcher Versus Operating Room Table
An observational study of Post-operative Complications and Operative Surfaces, run by Brett Lewellyn at 1 site in United States.
Trial summary
The purpose of this study is to determine if there is any difference with regard to complication rates for performing surgery on an operating room (OR) table vs performing surgery on a stretcher with a hand table. Read more about this study
- Who is it for?
- Ages 18 to 88 years
- Conditions the study is for
- Post-operative Complications, Operative Surfaces
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2017to 18 Aug 2021
- 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 88 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: two outpatient surgery centers and an inpatient hospital center
Who may be able to join
- Inclusion criteria will involve skeletally mature adult patients who are to be operated on by the principal investigator, in a one year time frame, for any surgical procedure of the upper extremity from the fingertip to the middle portion of the arm above the elbow.
Who cannot join
- Exclusion criteria will include: the skeletally immature, any patient with pre-existing neck pain, back pain, or decubitus ulcers; and patients with preexisting "pain" related or other conflicting medical issues: i.e. fibromyalgia; patients who were unable to respond for themselves in postop follow up i.e. dementia, Parkinson's disease, Alzheimer's and stroke.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient Positioning for Hand, Wrist, and Elbow Surgery: Stretcher Versus Operating Room Table, A Randomized Controlled Trial
The purpose of this study is to determine if there is any difference with regard to complication rates for performing surgery on an operating room (OR) table vs performing surgery on a stretcher with a hand table. The OR table and the stretcher with a hand table are the two types of operative surfaces the investigators will compare. The aim of this study is to compare surgeries of finger, hand, wrist, forearm, and elbow. The investigators will conduct the research at two outpatient surgery centers and an inpatient hospital center to see if operating room surface and time of surgery has any effect on complications after surgery. The investigators also will compare the costs of the two types of operative surfaces for the surgery.
Read the detailed description
The primary objective is to determine if there is any difference with regard to complication rate for performing surgery on an OR table vs performing surgery on a stretcher with a hand table. Outcome measures will include any complications recorded by postoperative questionnaires filled out by patients, and examination of the data to see if there is any statistically significant (using P values) data.
- Conditions
- Post-operative Complications, Operative Surfaces
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 |
|---|---|---|
| patients randomized to undergo surgery on an OR table | Not described | |
| patients randomized to undergo surgery on a stretcher with a hand table | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective is to determine if there are increased or decreased complications when comparing patients who are having surgical procedures on an OR table vs a standard hospital stretcher.
Measured: From enrollment to one year postoperative
Secondary outcomes (1)
This will include determining any correlation between surgical time, length of follow up and complication rate according to surgical procedure and operating surface.
Measured: From enrollment to one year postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start3 Aug 2017
- Primary completion18 Aug 2021
- Study completion18 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-operative ComplicationsStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brett Lewellyn
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Brett Lewellyn, Orlando Health, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07063784
- Sponsor's protocol ID
- 17.048.05
- Status last verified
- Jul 2025
- First submitted
- 24 Jun 2025
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Positioning for Hand, Wrist, and Elbow Surgery: Stretcher Versus Operating Room Table, A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07063784
- Acronym / sponsor ID
- 17.048.05
- Conditions
- Post-operative Complications, Operative Surfaces
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Brett LewellynUniversity, hospital or other
- Study start
- 3 Aug 2017 (actual)
- Primary completion
- 18 Aug 2021 (actual)
- Study completion
- 18 Aug 2021 (actual)
- First posted
- 14 Jul 2025 (actual)
- 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 study is to determine if there is any difference with regard to complication rates for performing surgery on an operating room (OR) table vs performing surgery on a stretcher with a hand table. The OR table and the stretcher with a hand table are the two types of operative surfaces the investigators will compare. The aim of this study is to compare surgeries of finger, hand, wrist, forearm, and elbow. The investigators will conduct the research at two outpatient surgery centers and an inpatient hospital center to see if operating room surface and time of surgery has any effect on complications after surgery. The investigators also will compare the costs of the two types of operative surfaces for the surgery.
Detailed description
The primary objective is to determine if there is any difference with regard to complication rate for performing surgery on an OR table vs performing surgery on a stretcher with a hand table. Outcome measures will include any complications recorded by postoperative questionnaires filled out by patients, and examination of the data to see if there is any statistically significant (using P values) data.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients randomized to undergo surgery on an OR table | – | – |
| patients randomized to undergo surgery on a stretcher with a hand table | – | – |
Who may qualify
- Ages
- 18 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- two outpatient surgery centers and an inpatient hospital center
Key inclusion criteria (1 listed)
- Inclusion criteria will involve skeletally mature adult patients who are to be operated on by the principal investigator, in a one year time frame, for any surgical procedure of the upper extremity from the fingertip to the middle portion of the arm above the elbow.
Key exclusion criteria (1 listed)
- Exclusion criteria will include: the skeletally immature, any patient with pre-existing neck pain, back pain, or decubitus ulcers; and patients with preexisting "pain" related or other conflicting medical issues: i.e. fibromyalgia; patients who were unable to respond for themselves in postop follow up i.e. dementia, Parkinson's disease, Alzheimer's and stroke.
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
The primary objective is to determine if there are increased or decreased complications when comparing patients who are having surgical procedures on an OR table vs a standard hospital stretcher.
Time frame: From enrollment to one year postoperative
1 secondary outcome
This will include determining any correlation between surgical time, length of follow up and complication rate according to surgical procedure and operating surface.
Time frame: From enrollment to one year postoperative
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 5 Aug 2025.
- Individual participant dataSharing planned: No
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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 Post-operative Complications and Operative Surfaces, run by Brett Lewellyn 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 1 inclusion and 1 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 5 Aug 2025. 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?
The primary objective is to determine if there are increased or decreased complications when comparing patients who are having surgical procedures on an OR table vs a standard hospital stretcher. (time frame: From enrollment to one year postoperative). 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 5 Aug 2025.