Total Knee ArthroplastyNCT01924403
Perfusion Assessment of Wound Closure Techniques in Primary Total Knee Arthroplasty
A study testing Staple Closure, Vertical Mattress Closure and Running Subcuticular Closure in people with Total Knee Arthroplasty, run by Mayo Clinic at 1 site in United States.
Trial summary
This study will assess which of the three most common methods of wound closure in primary total knee arthroplasty (staples, interrupted vertical mattress, or running subcuticular suture) provide the best wound vascular perfusion. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- Staple Closure, Vertical Mattress Closure and Running Subcuticular Closure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Jul 2014
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥ 18 years old
- Primary diagnosis of osteoarthritis
- Surgical indication for index total knee arthroplasty
Who cannot join
- Previous surgery about the knee
- Systemic corticosteroid use
- Active infection of any kind or chronic infection with HIV, Hepatitis C, or Syphilis
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Assessment of Wound Closure Techniques in Primary Total Knee Arthroplasty Using SPY Intra-operative Angiography
This study will assess which of the three most common methods of wound closure in primary total knee arthroplasty (staples, interrupted vertical mattress, or running subcuticular suture) provide the best wound vascular perfusion. This can be achieve by using SPY intra-operative vascular angiography, which is commonly used in clinical practice to assess perfusion of wound closure at the clinic. By understanding the differences in perfusion afforded by different closure techniques, surgeons will then be able to select the technique that optimizes this parameter so as to avoid complications such as tissue necrosis, wound dehiscence, or infection.
- Conditions
- Total Knee Arthroplasty
- Being tested
- Staple Closure, Vertical Mattress Closure, Running Subcuticular Closure
- Keywords
- TKA, Wound Closure, Wound Perfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Staple ClosureProcedure or surgery
Vertical Mattress ClosureProcedure or surgery
Running Subcuticular ClosureProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Staple Closure | Experimental | Staple closure will be one technique employed to close the wound in primary total knee arthroplasty. Receives: Procedure: Staple Closure |
| Running Subcuticular Closure | Experimental | Running subcuticular closure will be one technique employed to close the wound in primary total knee arthroplasty. Receives: Procedure: Running Subcuticular Closure |
| Vertical Mattress Closure | Experimental | Vertical mattress closure will be one technique employed to close the wound in primary total knee arthroplasty. Receives: Procedure: Vertical Mattress Closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perfusion of Wound Closure
Measured: Surgical Point of Care
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionJul 2014
- Study completionJul 2014
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 Mayo ClinicThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert T. Trousdale, Mayo Clinic
- Investigators
- Robert Trousdale, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01924403
- Sponsor's protocol ID
- 13-005083
- Status last verified
- Feb 2015
- First submitted
- 14 Aug 2013
- Last updated
- 16 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Wyles CC, Jacobson SR, Houdek MT, Larson DR, Taunton MJ, Sim FH, Sierra RJ, Trousdale RT. The Chitranjan Ranawat Award: Running Subcuticular Closure Enables the Most Robust Perfusion After TKA: A Randomized Clinical Trial. Clin Orthop Relat Res. 2016 Jan;474(1):47-56. doi: 10.1007/s11999-015-4209-x.
PubMed 25733009
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Wound Closure Techniques in Primary Total Knee Arthroplasty Using SPY Intra-operative Angiography
- ClinicalTrials.gov ID
- NCT01924403
- Acronym / sponsor ID
- 13-005083
- Conditions
- Total Knee Arthroplasty
- Keywords
- TKA, Wound Closure, Wound Perfusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 16 Aug 2013 (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 assess which of the three most common methods of wound closure in primary total knee arthroplasty (staples, interrupted vertical mattress, or running subcuticular suture) provide the best wound vascular perfusion. This can be achieve by using SPY intra-operative vascular angiography, which is commonly used in clinical practice to assess perfusion of wound closure at the clinic. By understanding the differences in perfusion afforded by different closure techniques, surgeons will then be able to select the technique that optimizes this parameter so as to avoid complications such as tissue necrosis, wound dehiscence, or infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Staple Closure | Experimental | Procedure: Staple ClosureStaple closure will be one technique employed to close the wound in primary total knee arthroplasty. |
| Running Subcuticular Closure | Experimental | Procedure: Running Subcuticular ClosureRunning subcuticular closure will be one technique employed to close the wound in primary total knee arthroplasty. |
| Vertical Mattress Closure | Experimental | Procedure: Vertical Mattress ClosureVertical mattress closure will be one technique employed to close the wound in primary total knee arthroplasty. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥ 18 years old
- Primary diagnosis of osteoarthritis
- Surgical indication for index total knee arthroplasty
Key exclusion criteria (3 listed)
- Previous surgery about the knee
- Systemic corticosteroid use
- Active infection of any kind or chronic infection with HIV, Hepatitis C, or Syphilis
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 |
|---|---|---|
| Staple Closure | Procedure or surgery | Staple Closure |
| Vertical Mattress Closure | Procedure or surgery | Vertical Mattress Closure |
| Running Subcuticular Closure | Procedure or surgery | Running Subcuticular Closure |
Primary outcome
Perfusion of Wound Closure
Time frame: Surgical Point of Care
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 16 Feb 2015.
- Derived from this study: PubMed 25733009Wyles CC, Jacobson SR, Houdek MT, Larson DR, Taunton MJ, Sim FH, Sierra RJ, Trousdale RT. The Chitranjan Ranawat Award: Running Subcuticular Closure Enables the Most Robust Perfusion After TKA: A Randomized Clinical Trial. Clin Orthop Relat Res. 2016 Jan;474(1):47-56. doi: 10.1007/s11999-015-4209-x.
Related trials for Total Knee Arthroplasty
RecruitingPhase 3
REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
Venous Thromboembolism (VTE)
Recruiting
SII Levels Following iPACK Block With Adductor Canal Block in Knee Arthroplasty
Knee Osteoarthritis
Enrolling by invitationObservational study
Persona SoluTion PPS Femur PMCF
Rhematoid Arthritis, Osteo Arthritis of the Knee
Recruiting
ACB and iPACK Blocks With Intravenous Dexamethasone and Perineural Dexmedetomidine in Total Knee Arthroplasty
Knee Osteoarthritis
RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Symptomatic Venous Thromboembolism (VTE)
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.
Robert Trousdale, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Staple Closure, Vertical Mattress Closure and Running Subcuticular Closure in people with Total Knee Arthroplasty, run by Mayo Clinic 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 3 inclusion and 3 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 16 Feb 2015. 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?
Perfusion of Wound Closure (time frame: Surgical Point of Care). 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 NCT01924403, 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 16 Feb 2015.