Meniscus TearFCARNCT06541756
Fibrine Clot-augmented Repair of Longitudinal Meniscus Tears
A study testing Fibrine Clot-augmented Meniscal Repair and Conventional Meniscal Repair in people with Meniscus Tear and Meniscus Lesion, run by Ankara City Hospital Bilkent at 2 sites in Turkey (Türkiye).
Trial summary
Longitudinal meniscal tears are a type of meniscal injury characterized by a displaced fragment of the meniscus that flips over into the joint, often resembling a buckle or handle. These tears typically occur in the medial meniscus and are often associated with traumatic knee injuries, particularly in athletes. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Meniscus Tear, Meniscus Lesion, Fibrin Blood Clot
- What is being tested?
- Fibrine Clot-augmented Meniscal Repair and Conventional Meniscal Repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 25 Jul 2024to 31 Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Presenting with a painful meniscus (lateral or medial) longitudinal tear
- Being between the ages of 18 and 50
- Not having undergone surgery on the same knee before
- Having an MRI taken at the end of the 1st year post-surgery
Who cannot join
- Having additional collateral ligamentous damage along with the meniscus tear (such as MCL or LCL)
- Incomplete clinical scores at the end of the study
- A history of previous surgery on the same knee
- Having an active infection
- Not having a control MRI at the end of the 1st year
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Ankara Bilkent City Hospital
Ankara, 06000
Enejd Veizi, MD, +905439799959, dr.nad89@hotmail.com
- Recruiting
Ankara Etlik City Hospital
Ankara, 06000
Yasin Erdoğan, MD, +905056056097, yasin-erdgn@hotmail.com
About this study
Official title: Fibrine Clot-augmented Repair of Longitudinal Meniscus Tears - A Prospectively Randomized Controlled Trial
Longitudinal meniscal tears are a type of meniscal injury characterized by a displaced fragment of the meniscus that flips over into the joint, often resembling a buckle or handle. These tears typically occur in the medial meniscus and are often associated with traumatic knee injuries, particularly in athletes.
The displaced meniscal fragment can cause mechanical symptoms such as locking, clicking, or catching of the knee, as well as pain and swelling. If not properly treated, buckle-handle meniscal tears can lead to further complications, including chronic knee instability, increased risk of osteoarthritis, and persistent joint pain.Repairing a longitudinal meniscal tear offers several advantages over partial meniscectomy, particularly in preserving knee function and preventing long-term complications.
Read more
Meniscal repair aims to restore the integrity of the meniscus, which plays a crucial role in load distribution, shock absorption, and joint stability.
Utilizing a fibrin clot during the repair of a buckle-handle meniscal tear can enhance the healing process and improve surgical outcomes. Fibrin clots act as a biological scaffold, promoting tissue regeneration by providing a matrix that facilitates cellular migration and proliferation.
The purpose of this study was to compare longitudinal meniscal tear repair reinforced with fibrin clot with routine end-to-end repair in a prospective randomized controlled trial.
Read the detailed description
This study is designed as a prospective randomized controlled clinical trial. It aims to include patients presenting to the Orthopedics and Traumatology clinics at Ankara Bilkent and Etlik City Hospitals with longitudinal meniscus tears between August 2024 and December 2028. Participants will be randomly assigned to one of two groups: one receiving meniscus repair with fibrin clot reinforcement and the other receiving standard repair.
Patients in the standard repair group will undergo routine meniscus repair surgery using arthroscopic all-inside or inside-out sutures, with spinal anesthesia. For the fibrin clot group, a fibrin clot will be prepared from 50cc of bone marrow aspirate obtained from the iliac crest and mixed for 15 minutes. The fibrin clot will be shaped into a cylindrical form and compressed between the torn edges of the meniscus using a trocar system, then secured with sutures. After completing the repairs, the surgical wounds and portals will be closed, and an elastic bandage will be applied. The post-operative rehabilitation protocols will be the same for all patients.
Patients will be clinically followed for at least one year, with healing rates compared using control magnetic resonance imaging at the end of the first year.
- Conditions
- Meniscus Tear, Meniscus Lesion, Fibrin Blood Clot, Knee Injuries
- Being tested
- Fibrine Clot-augmented Meniscal Repair, Conventional Meniscal Repair
- Medical subject headings
- Knee Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fibrine Clot-augmented Meniscal RepairProcedure or surgery
The fibrin clot will be prepared from 50cc of bone marrow aspirate obtained from the iliac crest and mixed for 15 minutes. The fibrin clot will be shaped into a cylindrical form and compressed between the torn edges of the meniscus using a trocar system, then secured with sutures.
Conventional Meniscal RepairProcedure or surgery
Patients in the standard repair group will undergo routine meniscus repair surgery using arthroscopic all-inside or inside-out sutures.
| Study group | Role | What they receive |
|---|---|---|
| Fibrin Clot-augmented group | Experimental | Patients in the experimental repair group will undergo routine meniscus repair surgery in addition to a fibrin clot placed within the ruptured sides using arthroscopic all-inside or inside-out sutures. The fibrin clot will be prepared from 50cc of bone marrow aspirate obtained from the iliac crest and mixed for 15 minutes. The clot will be shaped into a cylindrical form and compressed between the torn edges of the meniscus using a trocar system, then secured with sutures. Receives: Procedure: Fibrine Clot-augmented Meniscal Repair |
| Conventionally repaired group | Active comparator | Patients in the control repair group will undergo routine meniscus repair surgery using arthroscopic all-inside or inside-out sutures. The ruptured sides will be approximated as usual and the procedure will be considered completed. Receives: Procedure: Conventional Meniscal Repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with a healed meniscus on MRI
Meniscal healing at 1 year follow up as detected on the control MRI (yes / no / partial)
Measured: Postoperative 1st year
Secondary outcomes (3)
Tegner Activity Scale
minimum value:0, maximum value 10, higher values mean better outcome
Measured: Postoperative 1.st year
The Knee injury and Osteoarthritis Outcome Score (KOOS)
minimum value:0, maximum value 100, higher values mean better outcome
Measured: Postoperative 1.st year
Tegner-Lysholm Score
minimum value:0, maximum value 100, higher values mean better outcome
Measured: Postoperative 1.st year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start25 Jul 2024
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Meniscus TearStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe 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
- Model description
- Prospective Randomized Controlled Study
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Collaborators
- Ankara Etlik City Hospital
- Responsible party
- Principal investigator, Enejd Veizi, MD, Ankara City Hospital Bilkent
- Investigators
- Enejd Veizi, MD, Principal investigator, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06541756
- Sponsor's protocol ID
- E2-24-7900
- Acronym
- FCAR
- Status last verified
- Sep 2025
- First submitted
- 1 Aug 2024
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Keller RE, O'Donnell EA, Medina GIS, Linderman SE, Cheng TTW, Sabbag OD, Oh LS. Biological augmentation of meniscal repair: a systematic review. Knee Surg Sports Traumatol Arthrosc. 2022 Jun;30(6):1915-1926. doi: 10.1007/s00167-021-06849-5. Epub 2022 Mar 8.
PubMed 35258647Chrysanthou C, Laliotis N, Paraskevas GK, Anastasopoulos N, Packer G. Enhancing Meniscal Repair: Investigating the Impact of an Exogenous Fibrin Clot. Cureus. 2024 Jan 27;16(1):e53083. doi: 10.7759/cureus.53083. eCollection 2024 Jan.
PubMed 38288322Rodriguez AN, Reist H, Liechti DJ, Geeslin AG, LaPrade RF. Shuttling Technique for Directed Fibrin Clot Placement During Augmented Inside-Out Repair of Horizontal Meniscus Tears. Arthrosc Tech. 2022 Nov 17;11(12):e2205-e2211. doi: 10.1016/j.eats.2022.08.027. eCollection 2022 Dec.
PubMed 36632380Kinoshita T, Hashimoto Y, Orita K, Iida K, Takahashi S, Nakamura H. Bone Marrow-Derived Fibrin Clots Stimulate Healing of a Knee Meniscal Defect in a Rabbit Model. Arthroscopy. 2023 Jul;39(7):1662-1670. doi: 10.1016/j.arthro.2022.12.013. Epub 2022 Dec 24.
PubMed 36574822Kale S, Deore S, Gunjotikar A, Singh S, Ghodke R, Agrawal P. Arthroscopic meniscus repair and augmentation with autologous fibrin clot in Indian population: A 2-year prospective study. J Clin Orthop Trauma. 2022 Aug 6;32:101969. doi: 10.1016/j.jcot.2022.101969. eCollection 2022 Sep.
PubMed 36035781
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fibrine Clot-augmented Repair of Longitudinal Meniscus Tears - A Prospectively Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06541756
- Acronym / sponsor ID
- FCAR / E2-24-7900
- Conditions
- Meniscus Tear, Meniscus Lesion, Fibrin Blood Clot, Knee Injuries
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Collaborators
- Ankara Etlik City Hospital
- Study start
- 25 Jul 2024 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 7 Aug 2024 (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.
Longitudinal meniscal tears are a type of meniscal injury characterized by a displaced fragment of the meniscus that flips over into the joint, often resembling a buckle or handle. These tears typically occur in the medial meniscus and are often associated with traumatic knee injuries, particularly in athletes.
The displaced meniscal fragment can cause mechanical symptoms such as locking, clicking, or catching of the knee, as well as pain and swelling. If not properly treated, buckle-handle meniscal tears can lead to further complications, including chronic knee instability, increased risk of osteoarthritis, and persistent joint pain.Repairing a longitudinal meniscal tear offers several advantages over partial meniscectomy, particularly in preserving knee function and preventing long-term complications.
Meniscal repair aims to restore the integrity of the meniscus, which plays a crucial role in load distribution, shock absorption, and joint stability.
Utilizing a fibrin clot during the repair of a buckle-handle meniscal tear can enhance the healing process and improve surgical outcomes. Fibrin clots act as a biological scaffold, promoting tissue regeneration by providing a matrix that facilitates cellular migration and proliferation.
The purpose of this study was to compare longitudinal meniscal tear repair reinforced with fibrin clot with routine end-to-end repair in a prospective randomized controlled trial.
Detailed description
This study is designed as a prospective randomized controlled clinical trial. It aims to include patients presenting to the Orthopedics and Traumatology clinics at Ankara Bilkent and Etlik City Hospitals with longitudinal meniscus tears between August 2024 and December 2028. Participants will be randomly assigned to one of two groups: one receiving meniscus repair with fibrin clot reinforcement and the other receiving standard repair.
Patients in the standard repair group will undergo routine meniscus repair surgery using arthroscopic all-inside or inside-out sutures, with spinal anesthesia. For the fibrin clot group, a fibrin clot will be prepared from 50cc of bone marrow aspirate obtained from the iliac crest and mixed for 15 minutes. The fibrin clot will be shaped into a cylindrical form and compressed between the torn edges of the meniscus using a trocar system, then secured with sutures. After completing the repairs, the surgical wounds and portals will be closed, and an elastic bandage will be applied. The post-operative rehabilitation protocols will be the same for all patients.
Patients will be clinically followed for at least one year, with healing rates compared using control magnetic resonance imaging at the end of the first year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective Randomized Controlled Study
| Arm | Type | Receives |
|---|---|---|
| Fibrin Clot-augmented group | Experimental | Procedure: Fibrine Clot-augmented Meniscal RepairPatients in the experimental repair group will undergo routine meniscus repair surgery in addition to a fibrin clot placed within the ruptured sides using arthroscopic all-inside or inside-out sutures. The fibrin clot will be prepared from 50cc of bone marrow aspirate obtained from the iliac crest and mixed for 15 minutes. The clot will be shaped into a cylindrical form and compressed between the torn edges of the meniscus using a trocar system, then secured with sutures. |
| Conventionally repaired group | Active comparator | Procedure: Conventional Meniscal RepairPatients in the control repair group will undergo routine meniscus repair surgery using arthroscopic all-inside or inside-out sutures. The ruptured sides will be approximated as usual and the procedure will be considered completed. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Presenting with a painful meniscus (lateral or medial) longitudinal tear
- Being between the ages of 18 and 50
- Not having undergone surgery on the same knee before
- Having an MRI taken at the end of the 1st year post-surgery
Key exclusion criteria (5 listed)
- Having additional collateral ligamentous damage along with the meniscus tear (such as MCL or LCL)
- Incomplete clinical scores at the end of the study
- A history of previous surgery on the same knee
- Having an active infection
- Not having a control MRI at the end of the 1st year
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 |
|---|---|---|
| Fibrine Clot-augmented Meniscal RepairThe fibrin clot will be prepared from 50cc of bone marrow aspirate obtained from the iliac crest and mixed for 15 minutes. The fibrin clot will be shaped into a cylindrical form and compressed between the torn edges of the meniscus using a trocar system, then secured with sutures. | Procedure or surgery | Fibrin Clot-augmented group |
| Conventional Meniscal RepairPatients in the standard repair group will undergo routine meniscus repair surgery using arthroscopic all-inside or inside-out sutures. | Procedure or surgery | Conventionally repaired group |
Primary outcome
Number of patients with a healed meniscus on MRI
Time frame: Postoperative 1st year
Meniscal healing at 1 year follow up as detected on the control MRI (yes / no / partial)
3 secondary outcomes
Tegner Activity Scale
Time frame: Postoperative 1.st year
The Knee injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Postoperative 1.st year
Tegner-Lysholm Score
Time frame: Postoperative 1.st year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Background: PubMed 35258647Keller RE, O'Donnell EA, Medina GIS, Linderman SE, Cheng TTW, Sabbag OD, Oh LS. Biological augmentation of meniscal repair: a systematic review. Knee Surg Sports Traumatol Arthrosc. 2022 Jun;30(6):1915-1926. doi: 10.1007/s00167-021-06849-5. Epub 2022 Mar 8.
- Background: PubMed 38288322Chrysanthou C, Laliotis N, Paraskevas GK, Anastasopoulos N, Packer G. Enhancing Meniscal Repair: Investigating the Impact of an Exogenous Fibrin Clot. Cureus. 2024 Jan 27;16(1):e53083. doi: 10.7759/cureus.53083. eCollection 2024 Jan.
- Background: PubMed 36632380Rodriguez AN, Reist H, Liechti DJ, Geeslin AG, LaPrade RF. Shuttling Technique for Directed Fibrin Clot Placement During Augmented Inside-Out Repair of Horizontal Meniscus Tears. Arthrosc Tech. 2022 Nov 17;11(12):e2205-e2211. doi: 10.1016/j.eats.2022.08.027. eCollection 2022 Dec.
- Background: PubMed 36574822Kinoshita T, Hashimoto Y, Orita K, Iida K, Takahashi S, Nakamura H. Bone Marrow-Derived Fibrin Clots Stimulate Healing of a Knee Meniscal Defect in a Rabbit Model. Arthroscopy. 2023 Jul;39(7):1662-1670. doi: 10.1016/j.arthro.2022.12.013. Epub 2022 Dec 24.
- Background: PubMed 36035781Kale S, Deore S, Gunjotikar A, Singh S, Ghodke R, Agrawal P. Arthroscopic meniscus repair and augmentation with autologous fibrin clot in Indian population: A 2-year prospective study. J Clin Orthop Trauma. 2022 Aug 6;32:101969. doi: 10.1016/j.jcot.2022.101969. eCollection 2022 Sep.
- 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.
Enejd Veizi, MD principal investigator
Ankara City Hospital Bilkent
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fibrine Clot-augmented Meniscal Repair and Conventional Meniscal Repair in people with Meniscus Tear and Meniscus Lesion, run by Ankara City Hospital Bilkent at 2 sites in Turkey (Türkiye).
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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Enejd Veizi, MD (+905439799959, dr.nad89@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with a healed meniscus on MRI (time frame: Postoperative 1st year). 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 NCT06541756, which also lists 5 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 2 Oct 2025.