Failed Total Knee ArthroplastyNCT01923805
Vitagel Revision Total Knee Arthroplasty
A study testing Vitagel in people with Failed Total Knee Arthroplasty, run by The Cleveland Clinic at 1 site in United States.
Trial summary
This prospective study will evaluate the effectiveness of Vitagel (VG) in reducing blood loss associated with Revision Total Knee Arthroplasty (RTKA) procedures by assessing the patient's change in hemoglobin/hematocrit. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Failed Total Knee Arthroplasty
- What is being tested?
- Vitagel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Mar 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must meet all of the following criteria in order to be considered appropriate candidates for participation in the study:
- Is scheduled for RTKA (may be the second stage/reimplantation of a two-stage revision for infection);
- Is able and willing to provide voluntary written informed consent for participation in the study and able to comply with protocol requirements;
- Is between the ages of 18 and 85 at the time of surgery. Both male and female will be included;
- Is physically and mentally willing and able to comply with the clinical and evaluation follow-up schedule;
Who cannot join
- The following exclusion criteria address safety and follow-up concerns or contraindications that could confound the study. If a patient exhibits any one of the following criteria, the patient is not eligible to participate in this study:
- Is known to be sensitive to any materials of bovine origin;
- Is undergoing a bilateral RTKA;
- Is undergoing a single component revision (i.e. tibial or femoral component only)
- Is undergoing a polyethylene revision only
- Is predonating autologous blood;
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- Have a preoperative platelet count of less than 100,000
- Have a previous history of venous thromboembolism or deep vein thrombosis;
- Have a medical condition requiring anticoagulation
- Currently using Coumadin;
- Have a history of Heparin induced thrombocytopenia or Lovenox induced thrombocytopenia;
- Have a history of rheumatoid arthritis or inflammatory arthritis;
- Have peripheral vascular disease;
- Have evidence of bleeding or metabolic-based hemolytic disorder (hemophilia or anticoagulation use), or hypercoaguable disorder;
- Have a history of liver disease. Patients with liver dysfunction from cirrhosis or hepatitis may have impaired production of factors in the clotting cascade which may make these individuals more prone to bleed, especially with the use of anticoagulants. For this reason, these patients will also be excluded from the study if a baseline INR is greater than 1.3 or APTT greater than 32.4;
- Have a history of failed treatment for abuse of, or are actively abusing, illegal drugs, solvents, or alcohol;
- Have a systemic infection or infection at site of surgery;
- Is a prisoner;
- Is pregnant or nursing and;
- Have a condition deemed by physician or medical staff to be non-conducive to patient's ability to complete the study, or a potential risk to the patient's health and well-being.
- Clinical evidence of cancer and/or infection at surgical site
- Use during the procedure of any other approved or unapproved product for the purpose of hemostasis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Randomized Evaluation of a Collagen/Thrombin Autologous Platelet Hemostatic Agent During Revision Knee Arthroplasty
This prospective study will evaluate the effectiveness of Vitagel (VG) in reducing blood loss associated with Revision Total Knee Arthroplasty (RTKA) procedures by assessing the patient's change in hemoglobin/hematocrit. Transfusion rates with the use of VG compared to the current standard of care will also be evaluated. The effectiveness of VG to potentially reduce pain, and increase return to function and quality of life will be assessed through the modified Knee Injury and Osteoarthritis Outcome Score (Modified KOOS), the Numerical Assessment Pain Scale (NAPS), and the SF-12 health survey. Analgesic use will be recorded post-operatively.
Read the detailed description
This is a prospective, randomized, blinded clinical trial involving 4 orthopedic surgeons who perform Revision Total Knee Arthroplasty (RTKA), including Trevor Murray (PI), Viktor Krebs, Robert Molloy, and Carlos Higuera. A total of eighty subjects scheduled for RTKA, who meet all inclusion criteria and exhibit none of the exclusion criteria will be invited to participate in the study. Only subjects who sign the Institutional Review Board-approved Informed Consent Form will be entered into the Study.
In the forty treatment Subjects, VG will be applied to each surgical site. The forty control subjects will receive the surgeon's standard of care, without the use of any other hemostatic agents. The subjects will not be informed of their assignment, and the research investigator making the determination on blood transfusion requirements for all study subjects will also be blinded to the subject assigned arm of the study. The research investigator performing RTKA will remain blinded to the study arm until the randomization envelope is opened, which will take place during surgery, after hemostasis is achieved using bovie electrocautery, and prior to closure of the knee capsule.
Assessments will be made per the Time and Events Schedule.
Subjects will be evaluated for intra- and post-operative complications, and all such events, should they occur, will be recorded during the course of the study. Details describing the event, cause of event, its treatment and resolution will be documented.
- Conditions
- Failed Total Knee Arthroplasty
- Being tested
- Vitagel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VitagelDevice
Vitagel
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Vitagel Receives: Device: Vitagel |
| Control | No intervention | Standard of care for surgical hemostasis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transfusion Requirements
The primary objective of this study is to test for significant differences in transfusion requirements in patients managed with RTKA.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 12 weeks.
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 startApr 2013
- Primary completionMar 2014
- Study completionMar 2014
Why it stopped: Difficulty enrolling patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Failed Total Knee ArthroplastyStudies of the same condition, open and under way.
- More trials run by The Cleveland 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Stryker Nordic
- Responsible party
- Sponsor
- Investigators
- Trevor Murray, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01923805
- Sponsor's protocol ID
- 12-1128
- Status last verified
- May 2017
- First submitted
- 26 Jul 2013
- Last updated
- 7 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: Study terminated early
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Evaluation of a Collagen/Thrombin Autologous Platelet Hemostatic Agent During Revision Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT01923805
- Acronym / sponsor ID
- 12-1128
- Conditions
- Failed Total Knee Arthroplasty
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty enrolling patients
- Enrolment
- 8 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- Stryker Nordic
- Study start
- Apr 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 16 Aug 2013 (estimated)
- Results
- Posted 7 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective study will evaluate the effectiveness of Vitagel (VG) in reducing blood loss associated with Revision Total Knee Arthroplasty (RTKA) procedures by assessing the patient's change in hemoglobin/hematocrit. Transfusion rates with the use of VG compared to the current standard of care will also be evaluated. The effectiveness of VG to potentially reduce pain, and increase return to function and quality of life will be assessed through the modified Knee Injury and Osteoarthritis Outcome Score (Modified KOOS), the Numerical Assessment Pain Scale (NAPS), and the SF-12 health survey. Analgesic use will be recorded post-operatively.
Detailed description
This is a prospective, randomized, blinded clinical trial involving 4 orthopedic surgeons who perform Revision Total Knee Arthroplasty (RTKA), including Trevor Murray (PI), Viktor Krebs, Robert Molloy, and Carlos Higuera. A total of eighty subjects scheduled for RTKA, who meet all inclusion criteria and exhibit none of the exclusion criteria will be invited to participate in the study. Only subjects who sign the Institutional Review Board-approved Informed Consent Form will be entered into the Study.
In the forty treatment Subjects, VG will be applied to each surgical site. The forty control subjects will receive the surgeon's standard of care, without the use of any other hemostatic agents. The subjects will not be informed of their assignment, and the research investigator making the determination on blood transfusion requirements for all study subjects will also be blinded to the subject assigned arm of the study. The research investigator performing RTKA will remain blinded to the study arm until the randomization envelope is opened, which will take place during surgery, after hemostasis is achieved using bovie electrocautery, and prior to closure of the knee capsule.
Assessments will be made per the Time and Events Schedule.
Subjects will be evaluated for intra- and post-operative complications, and all such events, should they occur, will be recorded during the course of the study. Details describing the event, cause of event, its treatment and resolution will be documented.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Device: VitagelVitagel |
| Control | No intervention | –Standard of care for surgical hemostasis. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients must meet all of the following criteria in order to be considered appropriate candidates for participation in the study:
Key exclusion criteria (22 listed)
- The following exclusion criteria address safety and follow-up concerns or contraindications that could confound the study. If a patient exhibits any one of the following criteria, the patient is not eligible to participate in this study:
- Clinical evidence of cancer and/or infection at surgical site
- Use during the procedure of any other approved or unapproved product for the purpose of hemostasis
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 |
|---|---|---|
| VitagelVitagel | Device | Treatment Group |
Primary outcome
Transfusion Requirements
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 12 weeks.
The primary objective of this study is to test for significant differences in transfusion requirements in patients managed with RTKA.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Study terminated early
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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.
Trevor Murray, MD principal investigator
The Cleveland 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 Vitagel in people with Failed Total Knee Arthroplasty, run by The Cleveland 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 5 inclusion and 22 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: stopped early, as of the sponsor's last update on 7 Jun 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?
Yes. Results are posted in the registry (first posted 7 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Transfusion Requirements (time frame: Participants will be followed for the duration of hospital stay, an expected average of 12 weeks.). 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 7 Jun 2017.