Effects of Platelet-Rich Fibrin on Knee Stability and Knee FunctionPhase 4NCT05904158
Effects of Platelet-Rich Fibrin in Patients With Anterior Cruciate Ligament Reconstruction
A Phase 4 study testing Platelet-Rich Fibrin during Standard ACL reconstruction surgery and Standard ACL reconstruction surgery in people with Effects of Platelet-Rich Fibrin on Knee Stability and Knee Function, run by Hacettepe University.
Trial summary
The study was conducted to investigate the effects of platelet-rich fibrin on knee stability, knee muscle strength and knee function in patients with ACL reconstruction. Thirty patients with ACL reconstruction were included to the study and randomly divided into two groups. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Effects of Platelet-Rich Fibrin on Knee Stability and Knee Function
- What is being tested?
- Platelet-Rich Fibrin during Standard ACL reconstruction surgery and Standard ACL reconstruction surgery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2010to 20 Aug 2022
- Phase
- Phase 4
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Being isolated ACL reconstruction,
- Being between the ages of 18-45 years,
- Performing sports recreationally or professionally
Who cannot join
- Having previous knee surgery,
- Having systematic disease,
- Having multiple ligament injury on the knee or additional cartilage injuries
About this study
Official title: Effects of Platelet-Rich Fibrin on Knee Muscle Strength and Function in Patients With Anterior Cruciate Ligament Reconstruction
The study was conducted to investigate the effects of platelet-rich fibrin on knee stability, knee muscle strength and knee function in patients with ACL reconstruction. Thirty patients with ACL reconstruction were included to the study and randomly divided into two groups. Patients were assessed preoperative and at the postoperative 1-year.
Read the detailed description
The study was conducted yo investigate the effects of platelet-rich fibrin (PRF) on the knee stability and function in patients with anterior cruciate ligament (ACL) reconstruction. Thirty patients with ACL reconstruction were included to the study and randomly divided into two groups (PRF group and control group). Hamstring tendon autograft was used in all patients for the reconstruction of the teared ACL. A standardized postoperative rehabilitation program was applied to all patients. Patients' knee stability, knee muscle strength and knee function were assessed preoperatively and one-year postoperatively. Knee stability was assessed using KT-2000 Knee Arthrometer. Quadriceps femoris and hamstring muscle strength measurements were conducted with an isokinetic dynamometer at 60˚/sec and 180˚/sec angular velocities. One Leg Hop (OLH) and Y-Balance tests, and International Knee Documentation Committee (IKDC) were used to evaluate the knee function.
- Being tested
- Platelet-Rich Fibrin during Standard ACL reconstruction surgery, Standard ACL reconstruction surgery
- Keywords
- Anterior cruciate ligament, platelet-rich fibrin, return to play
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet-Rich Fibrin during Standard ACL reconstruction surgeryBiological
Plateleth-rich fibrin was obtained from patients own blood (40 cc) and applied to the tunnels which were drilled for ACL graft
Standard ACL reconstruction surgeryOther
This was a control group where patients received Standard ACL reconstruction surgery
| Study group | Role | What they receive |
|---|---|---|
| PRF Group | Experimental | Patients in this group, received PRF application during the standard ACL reconstruction surgery Receives: Biological: Platelet-Rich Fibrin during Standard ACL reconstruction surgery |
| Control Group | Active comparator | Patients in this group received a standard ACL reconstruction surgery without any other intervention. Receives: Other: Standard ACL reconstruction surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the Knee Laxity
Knee laxity was measured using Kneelax-3 Knee arthrometer
Measured: Preoperatively ans one year postoperatively
Secondary outcomes (2)
Changes in the Knee Muscle Strenght
Qudriceps and hamstring muscle strength were measured using an isokinetic dynamometer
Measured: Preoperatively ans one year postoperatively
Changes in the Knee Function
Knee function was assessed with one leg hop (OLH) test and Y-Balance tests
Measured: Preoperatively and one year postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start15 Jun 2010
- Primary completion20 Aug 2022
- Study completion20 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effects of Platelet-Rich Fibrin on Knee Stability and Knee FunctionStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised controlled design
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Collaborators
- Ankara City Hospital Bilkent
- Responsible party
- Principal investigator, SERDAR DEMIRCI, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05904158
- Sponsor's protocol ID
- E-18-2060
- Status last verified
- Jun 2023
- First submitted
- 27 May 2023
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Platelet-Rich Fibrin on Knee Muscle Strength and Function in Patients With Anterior Cruciate Ligament Reconstruction
- ClinicalTrials.gov ID
- NCT05904158
- Acronym / sponsor ID
- E-18-2060
- Keywords
- Anterior cruciate ligament, platelet-rich fibrin, return to play
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Collaborators
- Ankara City Hospital Bilkent
- Study start
- 15 Jun 2010 (actual)
- Primary completion
- 20 Aug 2022 (actual)
- Study completion
- 20 Aug 2022 (actual)
- First posted
- 15 Jun 2023 (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.
The study was conducted to investigate the effects of platelet-rich fibrin on knee stability, knee muscle strength and knee function in patients with ACL reconstruction. Thirty patients with ACL reconstruction were included to the study and randomly divided into two groups. Patients were assessed preoperative and at the postoperative 1-year.
Detailed description
The study was conducted yo investigate the effects of platelet-rich fibrin (PRF) on the knee stability and function in patients with anterior cruciate ligament (ACL) reconstruction. Thirty patients with ACL reconstruction were included to the study and randomly divided into two groups (PRF group and control group). Hamstring tendon autograft was used in all patients for the reconstruction of the teared ACL. A standardized postoperative rehabilitation program was applied to all patients. Patients' knee stability, knee muscle strength and knee function were assessed preoperatively and one-year postoperatively. Knee stability was assessed using KT-2000 Knee Arthrometer. Quadriceps femoris and hamstring muscle strength measurements were conducted with an isokinetic dynamometer at 60˚/sec and 180˚/sec angular velocities. One Leg Hop (OLH) and Y-Balance tests, and International Knee Documentation Committee (IKDC) were used to evaluate the knee function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised controlled design
| Arm | Type | Receives |
|---|---|---|
| PRF Group | Experimental | Biological: Platelet-Rich Fibrin during Standard ACL reconstruction surgeryPatients in this group, received PRF application during the standard ACL reconstruction surgery |
| Control Group | Active comparator | Other: Standard ACL reconstruction surgeryPatients in this group received a standard ACL reconstruction surgery without any other intervention. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Being isolated ACL reconstruction,
- Being between the ages of 18-45 years,
- Performing sports recreationally or professionally
Key exclusion criteria (3 listed)
- Having previous knee surgery,
- Having systematic disease,
- Having multiple ligament injury on the knee or additional cartilage injuries
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 during Standard ACL reconstruction surgeryPlateleth-rich fibrin was obtained from patients own blood (40 cc) and applied to the tunnels which were drilled for ACL graft | Biological | PRF Group |
| Standard ACL reconstruction surgeryThis was a control group where patients received Standard ACL reconstruction surgery | Other | Control Group |
Primary outcome
Changes in the Knee Laxity
Time frame: Preoperatively ans one year postoperatively
Knee laxity was measured using Kneelax-3 Knee arthrometer
2 secondary outcomes
Changes in the Knee Muscle Strenght
Time frame: Preoperatively ans one year postoperatively
Changes in the Knee Function
Time frame: Preoperatively and one year postoperatively
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 Jun 2023.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Platelet-Rich Fibrin during Standard ACL reconstruction surgery and Standard ACL reconstruction surgery in people with Effects of Platelet-Rich Fibrin on Knee Stability and Knee Function, run by Hacettepe University.
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 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Changes in the Knee Laxity (time frame: Preoperatively ans one year postoperatively). 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 15 Jun 2023.