Knee DiseaseFibrin4FastNCT04165863
Effectiveness of Treatment With Rich Platelet Fibrin (PRF) VS Gold Standard in Patients Undergoing Knee Replacement
A study testing total knee replacement surgery in people with Knee Disease, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
Randomized controlled single blind trial for the evaluation of the treatment of the surgical wound healing process with Platelet-Rich-Fibrin compared to the gold standard (without Platelet-Rich-Fibrin) in patients undergoing knee replacement. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Knee Disease
- What is being tested?
- total knee replacement surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteItaly
- Study dates
- 20 Jan 2020to 4 Nov 2021
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females undergoing a total knee prosthesis.
- Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions.
- Hb > 11 g/dl; Platelet value > 150.000 plt/mmc;
- Patients with non clinical alteration of ECG;
- Signature of informed consent;
Who cannot join
- Patients incapable of understanding and of wanting;
- Systemic disorders such as diabetes, rheumatic diseases;
- Patients with malignancy;
- Thyroid metabolic disorders ;
- Abuse of alcohol, drugs and pharmaceutical drugs
- Body mass index > 40;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Treatment With Rich Platelet Fibrin (PRF) VS Gold Standard in the Healing Process of Surgical Wounds in Patients Undergoing Knee Replacement
Randomized controlled single blind trial for the evaluation of the treatment of the surgical wound healing process with Platelet-Rich-Fibrin compared to the gold standard (without Platelet-Rich-Fibrin) in patients undergoing knee replacement.
- Conditions
- Knee Disease
- Being tested
- total knee replacement surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
total knee replacement surgeryProcedure or surgery
total knee replacement surgery
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | treatment of the surgical wound healing process with Platelet-rich-fibrin in patients undergoing total knee replacement surgery Receives: Procedure: total knee replacement surgery |
| B | Active comparator | Gold standard treatment of the surgical wound healing process without Platelet-rich-fibrin in patients undergoing total knee replacement surgery Receives: Procedure: total knee replacement surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical improvement of the healing process
Clinical improvement of the healing process, assessed by application of the Hollander Wound Evaluation Scales at 2 weeks of follow up
Measured: 2 weeks
Secondary outcomes (1)
Dermatology life quality
Dermatology life quality index improvement at 3 days, 15 days and 1 month
Measured: 3 days, 15 days and 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2019
- Study start20 Jan 2020
- Primary completion4 Nov 2021
- Study completion4 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Knee DiseaseStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04165863
- Sponsor's protocol ID
- Fibrin4Fast
- Acronym
- Fibrin4Fast
- Status last verified
- Nov 2019
- First submitted
- 14 Nov 2019
- Last updated
- 19 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Harato K, Tanikawa H, Morishige Y, Kaneda K, Niki Y. What are the important surgical factors affecting the wound healing after primary total knee arthroplasty? J Orthop Surg Res. 2016 Jan 13;11:7. doi: 10.1186/s13018-016-0340-y.
PubMed 26762213Galat DD, McGovern SC, Larson DR, Harrington JR, Hanssen AD, Clarke HD. Surgical treatment of early wound complications following primary total knee arthroplasty. J Bone Joint Surg Am. 2009 Jan;91(1):48-54. doi: 10.2106/JBJS.G.01371.
PubMed 19122078Rui M, Zheng X, Sun SS, Li CY, Zhang XC, Guo KJ, Zhao FC, Pang Y. A prospective randomised comparison of 2 skin closure techniques in primary total hip arthroplasty surgery. Hip Int. 2018 Jan;28(1):101-105. doi: 10.5301/hipint.5000534.
PubMed 29148019
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Treatment With Rich Platelet Fibrin (PRF) VS Gold Standard in the Healing Process of Surgical Wounds in Patients Undergoing Knee Replacement
- ClinicalTrials.gov ID
- NCT04165863
- Acronym / sponsor ID
- Fibrin4Fast / Fibrin4Fast
- Conditions
- Knee Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 20 Jan 2020 (actual)
- Primary completion
- 4 Nov 2021 (actual)
- Study completion
- 4 Nov 2021 (actual)
- First posted
- 18 Nov 2019 (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.
Randomized controlled single blind trial for the evaluation of the treatment of the surgical wound healing process with Platelet-Rich-Fibrin compared to the gold standard (without Platelet-Rich-Fibrin) in patients undergoing knee replacement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Procedure: total knee replacement surgerytreatment of the surgical wound healing process with Platelet-rich-fibrin in patients undergoing total knee replacement surgery |
| B | Active comparator | Procedure: total knee replacement surgeryGold standard treatment of the surgical wound healing process without Platelet-rich-fibrin in patients undergoing total knee replacement surgery |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males or females undergoing a total knee prosthesis.
- Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions.
- Hb > 11 g/dl; Platelet value > 150.000 plt/mmc;
- Patients with non clinical alteration of ECG;
- Signature of informed consent;
Key exclusion criteria (6 listed)
- Patients incapable of understanding and of wanting;
- Systemic disorders such as diabetes, rheumatic diseases;
- Patients with malignancy;
- Thyroid metabolic disorders ;
- Abuse of alcohol, drugs and pharmaceutical drugs
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 replacement surgerytotal knee replacement surgery | Procedure or surgery | A, B |
Primary outcome
clinical improvement of the healing process
Time frame: 2 weeks
Clinical improvement of the healing process, assessed by application of the Hollander Wound Evaluation Scales at 2 weeks of follow up
1 secondary outcome
Dermatology life quality
Time frame: 3 days, 15 days and 1 month
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 19 Jan 2022.
- Results publication: PubMed 26762213Harato K, Tanikawa H, Morishige Y, Kaneda K, Niki Y. What are the important surgical factors affecting the wound healing after primary total knee arthroplasty? J Orthop Surg Res. 2016 Jan 13;11:7. doi: 10.1186/s13018-016-0340-y.
- Results publication: PubMed 19122078Galat DD, McGovern SC, Larson DR, Harrington JR, Hanssen AD, Clarke HD. Surgical treatment of early wound complications following primary total knee arthroplasty. J Bone Joint Surg Am. 2009 Jan;91(1):48-54. doi: 10.2106/JBJS.G.01371.
- Results publication: PubMed 29148019Rui M, Zheng X, Sun SS, Li CY, Zhang XC, Guo KJ, Zhao FC, Pang Y. A prospective randomised comparison of 2 skin closure techniques in primary total hip arthroplasty surgery. Hip Int. 2018 Jan;28(1):101-105. doi: 10.5301/hipint.5000534.
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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?
A study testing total knee replacement surgery in people with Knee Disease, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
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 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: finished, as of the sponsor's last update on 19 Jan 2022. 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 Italy. 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?
clinical improvement of the healing process (time frame: 2 weeks). 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 NCT04165863, which also lists 3 linked publications.
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 19 Jan 2022.