Anterior Cruciate Ligament InjuryPRF-ACLNCT07257666
Sensory Deficit Following ACL Reconstruction: PRF Pilot Study
An observational study of Anterior Cruciate Ligament Injury and Knee Injuries, run by University of Belgrade at 1 site in Serbia.
Trial summary
Pilot, single-center, non-randomized, parallel-group clinical study designed to assess whether intraoperative application of autologous platelet-rich fibrin (PRF) at the bone-patellar tendon-bone (BPTB) donor site reduces postoperative anterior knee sensory deficit after anterior cruciate ligament (ACL) reconstruction… Read more about this study
- Who is it for?
- Ages 18 to 40 years, men only
- Conditions the study is for
- Anterior Cruciate Ligament Injury, Knee Injuries, Sensory Disorders
- What is being tested?
- Platelet-rich fibrin (PRF)
- Type of treatment
- Surgery or procedure
- How many people
- 53 participants
- Where
- 1 siteSerbia
- Study dates
- 7 Jan 2022to 14 Jul 2025
- 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 40 years
- Men only
- No healthy volunteers
- Adult
Study population: Patients undergoing ACL reconstruction with bone-patellar tendon-bone (BPTB) autograft at the University Clinical Center of Serbia
Who may be able to join
- Age 18-40 years
- Isolated anterior cruciate ligament rupture confirmed by MRI and clinical examination
- Planned ACL reconstruction with BPTB autograft
- Written informed consent provided
Who cannot join
- Previous knee surgery on the affected knee
- Associated ligament injuries requiring additional reconstruction
- Significant cartilage damage (Outerbridge grade III-IV beyond donor site changes)
- Systemic disease affecting wound healing (e.g., diabetes mellitus, autoimmune disease)
- Active infection
- Refusal or inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Platelet-rich Fibrin on the Regeneration of Patellar Ligament Defects and the Functional Recovery of Patients After Anterior Cruciate Ligament Reconstruction of the Knee
Pilot, single-center, non-randomized, parallel-group clinical study designed to assess whether intraoperative application of autologous platelet-rich fibrin (PRF) at the bone-patellar tendon-bone (BPTB) donor site reduces postoperative anterior knee sensory deficit after anterior cruciate ligament (ACL) reconstruction in competitively active male athletes. Planned enrollment is 53 participants allocated to a PRF cohort or a standard-care cohort. The primary outcome is the proportion of participants without anterior knee sensory deficit at 12 months post-surgery.
Read the detailed description
Background: Sensory deficit around the BPTB donor site is a recognized complication after ACL reconstruction and may affect patient satisfaction and functional recovery. PRF is an autologous bioregenerative product with potential to support soft-tissue healing.
Objective: To determine whether PRF application at the donor site reduces anterior knee sensory deficit compared with standard surgical care.
Design and Participants: Single-center, prospective, pilot, non-randomized study with two parallel cohorts (PRF vs standard care). Competitively active male athletes meeting prespecified eligibility criteria are followed at 4, 8, and 12 months post-surgery. Recruitment window: January 2022 to January 2023.
Interventions: In the PRF cohort, PRF is prepared intraoperatively and applied to the donor site per manufacturer protocol; the comparator cohort receives standard closure without PRF.
Assessments:
Primary outcome: Proportion of participants without anterior knee sensory deficit at 12 months. Sensory testing is performed over a predefined 9-point area lateral to the surgical scar (eyes closed; contralateral knee used as reference if uncertain).
Secondary outcomes: Patient-reported knee function instruments (International Knee Documentation Committee [IKDC] Subjective Knee Form and Lysholm Knee Scoring Scale), each reported as total score (0-100; higher scores indicate better function) at 4, 8, and 12 months; optional MRI-based assessments of the donor site per protocol; safety monitoring of adverse events.
Analysis (planned): Group comparisons using appropriate categorical and non-parametric methods with prespecified approaches to handle multiplicity.
- Conditions
- Anterior Cruciate Ligament Injury, Knee Injuries, Sensory Disorders, Bone-Patellar Tendon-Bone Autograft, Platelet-Rich Fibrin (PRF)
- Being tested
- Platelet-rich fibrin (PRF), Standard Closure (Control)
- Keywords
- Platelet-Rich Fibrin, ACL reconstruction, Bone-Patellar Tendon-Bone autograft, Anterior Cruciate Ligament Injury, Knee Surgery, Sensory Deficit, Donor Site Morbidity
- Medical subject headings
- Anterior Cruciate Ligament Injuries, Knee Injuries, Sensation Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet-rich fibrin (PRF)Biological
Also called Autologous PRF
Autologous PRF prepared intraoperatively from patient's venous blood and applied at the donor site after graft harvesting.
Standard Closure (Control)Procedure or surgery
Conventional closure of the donor site without PRF application
| Study group | Role | What they receive |
|---|---|---|
| PRF Group | Patients undergoing ACL reconstruction with a bone-patellar tendon-bone (BPTB) autograft, with platelet-rich fibrin (PRF) applied at the donor site (n=24) Receives: Biological: Platelet-rich fibrin (PRF) | |
| Control Group | Patients undergoing ACL reconstruction with a BPTB autograft, treated with standard closure without PRF (n=29) Receives: Procedure: Standard Closure (Control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants without anterior knee sensory deficit at the donor site
Sensory function assessed over a predefined 9-point area lateral to the surgical scar; deficit coded as 1 if >3 points are reported as "no or altered touch," otherwise 0. Assessment performed with eyes closed; contralateral knee used for reference if uncertain. Measure Type \& Units: Percentage of participants (%)
Measured: 12 months post-surgery
Secondary outcomes (1)
International Knee Documentation Committee (IKDC) Subjective Knee Form score (0-100; higher scores indicate better function)
Patient-reported outcome; total score ranges from 0 (worst) to 100 (best).
Measured: Baseline, 4, 8, and 12 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start7 Jan 2022
- Primary completion7 Jan 2023
- Study completion14 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament InjuryStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Belgrade
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Darko Milovanovic, University of Belgrade
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07257666
- Sponsor's protocol ID
- Eticka komisija 17/VI-3
- Other IDs
- 17/VI-3
- Acronym
- PRF-ACL
- Status last verified
- Dec 2025
- First submitted
- 23 Sep 2025
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to privacy considerations and institutional regulations. Summary results will be published in peer-reviewed journals.
Publications
Shichman I, Baruchi D, Rachevsky G, Amzallag N, Brandstetter AS, Vidra M, Morag G. Bone filling decreases donor site morbidity after anterior cruciate ligament reconstruction with bone-patellar tendon-bone autografts. Arch Orthop Trauma Surg. 2023 May;143(5):2565-2572. doi: 10.1007/s00402-022-04572-5. Epub 2022 Aug 2.
PubMed 35916963Milovanovic D, Kadija M, Gavrilovic D, Sreckovic S, Bilanovic M, Matic A, Vukman P. Sensory Deficit Following Anterior Cruciate Ligament Reconstruction with Bone-Patellar Tendon-Bone Autograft: Platelet-Rich Fibrin (PRF) Could Provide a Solution. Medicina (Kaunas). 2025 Dec 12;61(12):2202. doi: 10.3390/medicina61122202.
PubMed 41470204
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Platelet-rich Fibrin on the Regeneration of Patellar Ligament Defects and the Functional Recovery of Patients After Anterior Cruciate Ligament Reconstruction of the Knee
- ClinicalTrials.gov ID
- NCT07257666
- Acronym / sponsor ID
- PRF-ACL / Eticka komisija 17/VI-3
- Conditions
- Anterior Cruciate Ligament Injury, Knee Injuries, Sensory Disorders, Bone-Patellar Tendon-Bone Autograft, Platelet-Rich Fibrin (PRF)
- Keywords
- Platelet-Rich Fibrin, ACL reconstruction, Bone-Patellar Tendon-Bone autograft, Anterior Cruciate Ligament Injury, Knee Surgery, Sensory Deficit, Donor Site Morbidity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University of BelgradeUniversity, hospital or other
- Study start
- 7 Jan 2022 (actual)
- Primary completion
- 7 Jan 2023 (actual)
- Study completion
- 14 Jul 2025 (actual)
- First posted
- 2 Dec 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.
Pilot, single-center, non-randomized, parallel-group clinical study designed to assess whether intraoperative application of autologous platelet-rich fibrin (PRF) at the bone-patellar tendon-bone (BPTB) donor site reduces postoperative anterior knee sensory deficit after anterior cruciate ligament (ACL) reconstruction in competitively active male athletes. Planned enrollment is 53 participants allocated to a PRF cohort or a standard-care cohort. The primary outcome is the proportion of participants without anterior knee sensory deficit at 12 months post-surgery.
Detailed description
Background: Sensory deficit around the BPTB donor site is a recognized complication after ACL reconstruction and may affect patient satisfaction and functional recovery. PRF is an autologous bioregenerative product with potential to support soft-tissue healing.
Objective: To determine whether PRF application at the donor site reduces anterior knee sensory deficit compared with standard surgical care.
Design and Participants: Single-center, prospective, pilot, non-randomized study with two parallel cohorts (PRF vs standard care). Competitively active male athletes meeting prespecified eligibility criteria are followed at 4, 8, and 12 months post-surgery. Recruitment window: January 2022 to January 2023.
Interventions: In the PRF cohort, PRF is prepared intraoperatively and applied to the donor site per manufacturer protocol; the comparator cohort receives standard closure without PRF.
Assessments:
Primary outcome: Proportion of participants without anterior knee sensory deficit at 12 months. Sensory testing is performed over a predefined 9-point area lateral to the surgical scar (eyes closed; contralateral knee used as reference if uncertain).
Secondary outcomes: Patient-reported knee function instruments (International Knee Documentation Committee [IKDC] Subjective Knee Form and Lysholm Knee Scoring Scale), each reported as total score (0-100; higher scores indicate better function) at 4, 8, and 12 months; optional MRI-based assessments of the donor site per protocol; safety monitoring of adverse events.
Analysis (planned): Group comparisons using appropriate categorical and non-parametric methods with prespecified approaches to handle multiplicity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRF Group | – | Biological: Platelet-rich fibrin (PRF)Patients undergoing ACL reconstruction with a bone-patellar tendon-bone (BPTB) autograft, with platelet-rich fibrin (PRF) applied at the donor site (n=24) |
| Control Group | – | Procedure: Standard Closure (Control)Patients undergoing ACL reconstruction with a BPTB autograft, treated with standard closure without PRF (n=29) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients undergoing ACL reconstruction with bone-patellar tendon-bone (BPTB) autograft at the University Clinical Center of Serbia
Key inclusion criteria (4 listed)
- Age 18-40 years
- Isolated anterior cruciate ligament rupture confirmed by MRI and clinical examination
- Planned ACL reconstruction with BPTB autograft
- Written informed consent provided
Key exclusion criteria (6 listed)
- Previous knee surgery on the affected knee
- Associated ligament injuries requiring additional reconstruction
- Significant cartilage damage (Outerbridge grade III-IV beyond donor site changes)
- Systemic disease affecting wound healing (e.g., diabetes mellitus, autoimmune disease)
- Active infection
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 |
|---|---|---|
| Platelet-rich fibrin (PRF)Also: Autologous PRFAutologous PRF prepared intraoperatively from patient's venous blood and applied at the donor site after graft harvesting. | Biological | PRF Group |
| Standard Closure (Control)Conventional closure of the donor site without PRF application | Procedure or surgery | Control Group |
Primary outcome
Proportion of participants without anterior knee sensory deficit at the donor site
Time frame: 12 months post-surgery
Sensory function assessed over a predefined 9-point area lateral to the surgical scar; deficit coded as 1 if >3 points are reported as "no or altered touch," otherwise 0. Assessment performed with eyes closed; contralateral knee used for reference if uncertain. Measure Type \& Units: Percentage of participants (%)
1 secondary outcome
International Knee Documentation Committee (IKDC) Subjective Knee Form score (0-100; higher scores indicate better function)
Time frame: Baseline, 4, 8, and 12 months post-surgery
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 15 Dec 2025.
- Background: PubMed 35916963Shichman I, Baruchi D, Rachevsky G, Amzallag N, Brandstetter AS, Vidra M, Morag G. Bone filling decreases donor site morbidity after anterior cruciate ligament reconstruction with bone-patellar tendon-bone autografts. Arch Orthop Trauma Surg. 2023 May;143(5):2565-2572. doi: 10.1007/s00402-022-04572-5. Epub 2022 Aug 2.
- Derived from this study: PubMed 41470204Milovanovic D, Kadija M, Gavrilovic D, Sreckovic S, Bilanovic M, Matic A, Vukman P. Sensory Deficit Following Anterior Cruciate Ligament Reconstruction with Bone-Patellar Tendon-Bone Autograft: Platelet-Rich Fibrin (PRF) Could Provide a Solution. Medicina (Kaunas). 2025 Dec 12;61(12):2202. doi: 10.3390/medicina61122202.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to privacy considerations and institutional regulations. Summary results will be published in peer-reviewed journals.
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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 Anterior Cruciate Ligament Injury and Knee Injuries, run by University of Belgrade at 1 site in Serbia.
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 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 15 Dec 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 Serbia. 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?
Proportion of participants without anterior knee sensory deficit at the donor site (time frame: 12 months post-surgery). 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 NCT07257666, which also lists 2 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 15 Dec 2025; AzTrials last refreshed its copy on 26 Oct 2026.