OsteoarthritisPhase 4PRP014NCT02923700
Leukocyte-rich PRP vs Leukocyte-poor PRP for the Treatment of Knee Cartilage Degeneration: a Randomized Controlled Trial
A Phase 4 study testing Leukocyte-rich PRP intra-articular injections and Leukocyte-poor PRP intra-articular injections in people with Osteoarthritis, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
Platelet-rich Plasma (PRP) is the most exploited biologic agents currently used for the treatment of osteoarthritis (OA) of different joints, in particular knee OA. In previous studies, it has been showed its potential to reduce pain and improve functional status in patients treated by simple intra-articular… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Leukocyte-rich PRP intra-articular injections and Leukocyte-poor PRP intra-articular injections
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteItaly
- Study dates
- 26 Sep 2016to 27 May 2021
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients affected by mono-lateral symptomatic knee articular degenerative pathology with history of chronic (for at least 4 months) pain or swelling;
- imaging findings of degenerative changes of the joint (osteoarthritis or chondropathy with Kellgren Lawrence Score from 0 to 3 at X-ray evaluation).
Who cannot join
- age > 80 years;
- Kellgren-Lawrence score at X-ray evaluation > 3;
- major axial deviation (varus >5° , valgus > 5°),
- systemic disorders such as diabetes, rheumatoid arthritis, haematological diseases (coagulopathy), severe cardiovascular diseases, infections, immunodepression;
- patients in therapy with anticoagulants or antiaggregants;
- use of NSAIDs in the 5 days before blood donation;
- patients with Hb values < 11 g/dl and platelet values < 150,000/mmc.
Trial locations and contacts
1 site in 1 country.
About this study
Platelet-rich Plasma (PRP) is the most exploited biologic agents currently used for the treatment of osteoarthritis (OA) of different joints, in particular knee OA.
In previous studies, it has been showed its potential to reduce pain and improve functional status in patients treated by simple intra-articular injections. However, there are several PRP formulation currently available in clinical use, and therefore it is very difficult to compare data coming from trials using different products. The most debated aspect concerning PRP formulation is the role of leukocytes, which might stimulate an early inflammatory response in the joint due to the release of metalloproteases and other pro-inflammatory cytokines.
Read more
The investigators hypothesized that the presence of leukocytes in PRP could be clinically relevant in terms of outcome, so the present double blind randomized controlled trial was designed to compare leukocyte-rich and leukocyte-poor PRP injections for the treatment of knee OA.
A power analysis has been performed for the primary endpoint of IKDC (International Knee Documentation Committee) subjective score improvement at the 12-month follow-up for PRP. From a pilot study, a standard deviation of 15.2 points was found. With an alpha error of 0.05, a beta error of 0.2 and a minimal clinically significant difference of 6.7 points corresponding at 1/3 of the documented mean improvement, the minimum sample size was 83 for each group. Considering a possible drop out of 15%, 96 patients per group are required for total 192 patients, selected according to well-defined inclusion criteria (see 'Eligibility criteria' section). Patients are then assigned to two different treatment groups, according to a randomization list. The first group of treatment consists of three weekly intra-articular injections of autologous leukocyte-rich PRP, whereas the second group of patients will be treated by three intra-articular injections of leukocyte-poor PRP.
PRP will be obtained with the following procedure: a 300-ml autologous venous blood sample will undergo 2 centrifugations (the first at 1480 rpm for 6 minutes to separate erythrocytes, and a second at 3400 rpm for 15 minutes to concentrate platelets) to produced 20 ml of leukocyte-rich PRP. In case of patients allocated to receive leukocyte-poor PRP, a special filter will be then used to separate leukocytes and obtain leukocyte-poor PRP.
The total amount of PRP will be divided into 4 small units of 5 ml each. One unit is sent to the laboratory for analysis of platelet concentration and for a quality test, 3 units are stored at -30° C.
One week after the PRP production, the injective treatment starts, with 3 weekly injections. At the moment of the injection the syringe is properly covered to prevent the patient from discovering the substance he was receiving. After the injection, patients are sent home with instructions to limit the use of the leg for at least 24 h and to use cold therapy/ice on the affected area to relieve pain. During this period, the use of non-steroidal medication is forbidden.
Patients are prospectively evaluated basally and at 2, 6, and 12 months of follow-up using clinical subjective scores and objective parameters to determine clinical outcome (see 'Outcome measure' section). Patient satisfaction and adverse events will be also reported. All the clinical evaluations are performed by a medical staff not involved in the injective procedure, in order to keep the study double blinded. At the end of the study, the nature of the injected substance is revealed to the patients.
- Conditions
- Osteoarthritis
- Being tested
- Leukocyte-rich PRP intra-articular injections, Leukocyte-poor PRP intra-articular injections
- Keywords
- platelet rich plasma, intra-articular injection, leukocytes
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leukocyte-rich PRP intra-articular injectionsBiological
Leukocyte-poor PRP intra-articular injectionsBiological
| Study group | Role | What they receive |
|---|---|---|
| Leukocyte-rich PRP group | Experimental | Three weekly knee intra-articular injections of leukocyte-rich PRP Receives: Biological: Leukocyte-rich PRP intra-articular injections |
| Leukocyte-poor PRP group | Experimental | Three weekly knee intra-articular injections of leukocyte-poor PRP Receives: Biological: Leukocyte-poor PRP intra-articular injections |
What is being measured
The primary outcome is the main question the study is designed to answer.
IKDC (International knee documentation committee) score trend over time
Measured: basal (i.e. pre-treatment), 1 month, 2 months, 6 months and 12 months after treatment
Secondary outcomes (4)
KOOS (Knee Outcome Osteoarthritis Score) trend over time
Measured: basal (i.e. pre-treatment), 1 month, 2 months, 6 months and 12 months after treatment
VAS (Visual Analogue Scale) for Pain trend over time
Measured: basal (i.e. pre-treatment), 1 month, 2 months, 6 months and 12 months after treatment
Tegner Score trend over time
Measured: basal (i.e. pre-treatment), 1 month, 2 months, 6 months and 12 months after treatment
Adverse events report during follow-up period
Measured: ba1 month, 2 months, 6 months and 12 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2016 (estimated)
- Study start26 Sep 2016
- Primary completion26 Sep 2017
- Study completion27 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Berardo Di Matteo, MD, Study chair, I Clinic, Rizzoli Orthopaedic Institute, Bologna, ItalyAlessandro Di Martino, MD, Study chair, I Clinic, Rizzoli Orthopaedic Institute, Bologna, ItalyFrancesco Tentoni, MD, Study chair, I Clinic, Rizzoli Orthopaedic Institute, Bologna, ItalyAlice Roffi, BA, Study chair, Rizzoli Orthopaedic Institute, Bologna, ItalyElizaveta Kon, MD, Principal investigator, I Clinic, Rizzoli Orthopaedic Institute, Bologna, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02923700
- Sponsor's protocol ID
- PRP014
- Acronym
- PRP014
- Status last verified
- Aug 2021
- First submitted
- 30 Sep 2016
- Last updated
- 4 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Di Matteo B, Loibl M, Andriolo L, Filardo G, Zellner J, Koch M, Angele P. Biologic agents for anterior cruciate ligament healing: A systematic review. World J Orthop. 2016 Sep 18;7(9):592-603. doi: 10.5312/wjo.v7.i9.592. eCollection 2016 Sep 18.
PubMed 27672573van Drumpt RA, van der Weegen W, King W, Toler K, Macenski MM. Safety and Treatment Effectiveness of a Single Autologous Protein Solution Injection in Patients with Knee Osteoarthritis. Biores Open Access. 2016 Aug 1;5(1):261-8. doi: 10.1089/biores.2016.0014. eCollection 2016.
PubMed 27668131Mlynarek RA, Kuhn AW, Bedi A. Platelet-Rich Plasma (PRP) in Orthopedic Sports Medicine. Am J Orthop (Belle Mead NJ). 2016 Jul-Aug;45(5):290-326.
PubMed 27552452Sanchez M, Delgado D, Sanchez P, Muinos-Lopez E, Paiva B, Granero-Molto F, Prosper F, Pompei O, Perez JC, Azofra J, Padilla S, Fiz N. Combination of Intra-Articular and Intraosseous Injections of Platelet Rich Plasma for Severe Knee Osteoarthritis: A Pilot Study. Biomed Res Int. 2016;2016:4868613. doi: 10.1155/2016/4868613. Epub 2016 Jul 4.
PubMed 27462609Mariani E, Canella V, Cattini L, Kon E, Marcacci M, Di Matteo B, Pulsatelli L, Filardo G. Leukocyte-Rich Platelet-Rich Plasma Injections Do Not Up-Modulate Intra-Articular Pro-Inflammatory Cytokines in the Osteoarthritic Knee. PLoS One. 2016 Jun 3;11(6):e0156137. doi: 10.1371/journal.pone.0156137. eCollection 2016.
PubMed 27258008Sadabad HN, Behzadifar M, Arasteh F, Behzadifar M, Dehghan HR. Efficacy of Platelet-Rich Plasma versus Hyaluronic Acid for treatment of Knee Osteoarthritis: A systematic review and meta-analysis. Electron Physician. 2016 Mar 25;8(3):2115-22. doi: 10.19082/2115. eCollection 2016 Mar.
PubMed 27123220Yang J, Lu Y, Guo A. Platelet-rich plasma protects rat chondrocytes from interleukin-1beta-induced apoptosis. Mol Med Rep. 2016 Nov;14(5):4075-4082. doi: 10.3892/mmr.2016.5767. Epub 2016 Sep 23.
PubMed 27665780Yin WJ, Xu HT, Sheng JG, An ZQ, Guo SC, Xie XT, Zhang CQ. Advantages of Pure Platelet-Rich Plasma Compared with Leukocyte- and Platelet-Rich Plasma in Treating Rabbit Knee Osteoarthritis. Med Sci Monit. 2016 Apr 17;22:1280-90. doi: 10.12659/msm.898218.
PubMed 27086145Smyth NA, Haleem AM, Ross KA, Hannon CP, Murawski CD, Do HT, Kennedy JG. Platelet-Rich Plasma May Improve Osteochondral Donor Site Healing in a Rabbit Model. Cartilage. 2016 Jan;7(1):104-11. doi: 10.1177/1947603515599190.
PubMed 26958322Smith PA. Intra-articular Autologous Conditioned Plasma Injections Provide Safe and Efficacious Treatment for Knee Osteoarthritis: An FDA-Sanctioned, Randomized, Double-blind, Placebo-controlled Clinical Trial. Am J Sports Med. 2016 Apr;44(4):884-91. doi: 10.1177/0363546515624678. Epub 2016 Feb 1.
PubMed 26831629Di Martino A, Boffa A, Andriolo L, Romandini I, Altamura SA, Cenacchi A, Roverini V, Zaffagnini S, Filardo G. Leukocyte-Rich versus Leukocyte-Poor Platelet-Rich Plasma for the Treatment of Knee Osteoarthritis: A Double-Blind Randomized Trial. Am J Sports Med. 2022 Mar;50(3):609-617. doi: 10.1177/03635465211064303. Epub 2022 Feb 1.
PubMed 35103547
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leukocyte-rich PRP vs Leukocyte-poor PRP for the Treatment of Knee Cartilage Degeneration: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02923700
- Acronym / sponsor ID
- PRP014 / PRP014
- Conditions
- Osteoarthritis
- Keywords
- platelet rich plasma, intra-articular injection, leukocytes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 26 Sep 2016 (actual)
- Primary completion
- 26 Sep 2017 (actual)
- Study completion
- 27 May 2021 (actual)
- First posted
- 4 Oct 2016 (estimated)
- 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.
Platelet-rich Plasma (PRP) is the most exploited biologic agents currently used for the treatment of osteoarthritis (OA) of different joints, in particular knee OA.
In previous studies, it has been showed its potential to reduce pain and improve functional status in patients treated by simple intra-articular injections. However, there are several PRP formulation currently available in clinical use, and therefore it is very difficult to compare data coming from trials using different products. The most debated aspect concerning PRP formulation is the role of leukocytes, which might stimulate an early inflammatory response in the joint due to the release of metalloproteases and other pro-inflammatory cytokines.
The investigators hypothesized that the presence of leukocytes in PRP could be clinically relevant in terms of outcome, so the present double blind randomized controlled trial was designed to compare leukocyte-rich and leukocyte-poor PRP injections for the treatment of knee OA.
A power analysis has been performed for the primary endpoint of IKDC (International Knee Documentation Committee) subjective score improvement at the 12-month follow-up for PRP. From a pilot study, a standard deviation of 15.2 points was found. With an alpha error of 0.05, a beta error of 0.2 and a minimal clinically significant difference of 6.7 points corresponding at 1/3 of the documented mean improvement, the minimum sample size was 83 for each group. Considering a possible drop out of 15%, 96 patients per group are required for total 192 patients, selected according to well-defined inclusion criteria (see 'Eligibility criteria' section). Patients are then assigned to two different treatment groups, according to a randomization list. The first group of treatment consists of three weekly intra-articular injections of autologous leukocyte-rich PRP, whereas the second group of patients will be treated by three intra-articular injections of leukocyte-poor PRP.
PRP will be obtained with the following procedure: a 300-ml autologous venous blood sample will undergo 2 centrifugations (the first at 1480 rpm for 6 minutes to separate erythrocytes, and a second at 3400 rpm for 15 minutes to concentrate platelets) to produced 20 ml of leukocyte-rich PRP. In case of patients allocated to receive leukocyte-poor PRP, a special filter will be then used to separate leukocytes and obtain leukocyte-poor PRP.
The total amount of PRP will be divided into 4 small units of 5 ml each. One unit is sent to the laboratory for analysis of platelet concentration and for a quality test, 3 units are stored at -30° C.
One week after the PRP production, the injective treatment starts, with 3 weekly injections. At the moment of the injection the syringe is properly covered to prevent the patient from discovering the substance he was receiving. After the injection, patients are sent home with instructions to limit the use of the leg for at least 24 h and to use cold therapy/ice on the affected area to relieve pain. During this period, the use of non-steroidal medication is forbidden.
Patients are prospectively evaluated basally and at 2, 6, and 12 months of follow-up using clinical subjective scores and objective parameters to determine clinical outcome (see 'Outcome measure' section). Patient satisfaction and adverse events will be also reported. All the clinical evaluations are performed by a medical staff not involved in the injective procedure, in order to keep the study double blinded. At the end of the study, the nature of the injected substance is revealed to the patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Leukocyte-rich PRP group | Experimental | Biological: Leukocyte-rich PRP intra-articular injectionsThree weekly knee intra-articular injections of leukocyte-rich PRP |
| Leukocyte-poor PRP group | Experimental | Biological: Leukocyte-poor PRP intra-articular injectionsThree weekly knee intra-articular injections of leukocyte-poor PRP |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients affected by mono-lateral symptomatic knee articular degenerative pathology with history of chronic (for at least 4 months) pain or swelling;
- imaging findings of degenerative changes of the joint (osteoarthritis or chondropathy with Kellgren Lawrence Score from 0 to 3 at X-ray evaluation).
Key exclusion criteria (7 listed)
- age > 80 years;
- Kellgren-Lawrence score at X-ray evaluation > 3;
- major axial deviation (varus >5° , valgus > 5°),
- systemic disorders such as diabetes, rheumatoid arthritis, haematological diseases (coagulopathy), severe cardiovascular diseases, infections, immunodepression;
- patients in therapy with anticoagulants or antiaggregants;
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 |
|---|---|---|
| Leukocyte-rich PRP intra-articular injections | Biological | Leukocyte-rich PRP group |
| Leukocyte-poor PRP intra-articular injections | Biological | Leukocyte-poor PRP group |
Primary outcome
IKDC (International knee documentation committee) score trend over time
Time frame: basal (i.e. pre-treatment), 1 month, 2 months, 6 months and 12 months after treatment
4 secondary outcomes
KOOS (Knee Outcome Osteoarthritis Score) trend over time
Time frame: basal (i.e. pre-treatment), 1 month, 2 months, 6 months and 12 months after treatment
VAS (Visual Analogue Scale) for Pain trend over time
Time frame: basal (i.e. pre-treatment), 1 month, 2 months, 6 months and 12 months after treatment
Tegner Score trend over time
Time frame: basal (i.e. pre-treatment), 1 month, 2 months, 6 months and 12 months after treatment
Adverse events report during follow-up period
Time frame: ba1 month, 2 months, 6 months and 12 months after treatment
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 4 Aug 2021.
- Background: PubMed 27672573Di Matteo B, Loibl M, Andriolo L, Filardo G, Zellner J, Koch M, Angele P. Biologic agents for anterior cruciate ligament healing: A systematic review. World J Orthop. 2016 Sep 18;7(9):592-603. doi: 10.5312/wjo.v7.i9.592. eCollection 2016 Sep 18.
- Background: PubMed 27668131van Drumpt RA, van der Weegen W, King W, Toler K, Macenski MM. Safety and Treatment Effectiveness of a Single Autologous Protein Solution Injection in Patients with Knee Osteoarthritis. Biores Open Access. 2016 Aug 1;5(1):261-8. doi: 10.1089/biores.2016.0014. eCollection 2016.
- Background: PubMed 27552452Mlynarek RA, Kuhn AW, Bedi A. Platelet-Rich Plasma (PRP) in Orthopedic Sports Medicine. Am J Orthop (Belle Mead NJ). 2016 Jul-Aug;45(5):290-326.
- Background: PubMed 27462609Sanchez M, Delgado D, Sanchez P, Muinos-Lopez E, Paiva B, Granero-Molto F, Prosper F, Pompei O, Perez JC, Azofra J, Padilla S, Fiz N. Combination of Intra-Articular and Intraosseous Injections of Platelet Rich Plasma for Severe Knee Osteoarthritis: A Pilot Study. Biomed Res Int. 2016;2016:4868613. doi: 10.1155/2016/4868613. Epub 2016 Jul 4.
- Background: PubMed 27258008Mariani E, Canella V, Cattini L, Kon E, Marcacci M, Di Matteo B, Pulsatelli L, Filardo G. Leukocyte-Rich Platelet-Rich Plasma Injections Do Not Up-Modulate Intra-Articular Pro-Inflammatory Cytokines in the Osteoarthritic Knee. PLoS One. 2016 Jun 3;11(6):e0156137. doi: 10.1371/journal.pone.0156137. eCollection 2016.
- Background: PubMed 27123220Sadabad HN, Behzadifar M, Arasteh F, Behzadifar M, Dehghan HR. Efficacy of Platelet-Rich Plasma versus Hyaluronic Acid for treatment of Knee Osteoarthritis: A systematic review and meta-analysis. Electron Physician. 2016 Mar 25;8(3):2115-22. doi: 10.19082/2115. eCollection 2016 Mar.
- Background: PubMed 27665780Yang J, Lu Y, Guo A. Platelet-rich plasma protects rat chondrocytes from interleukin-1beta-induced apoptosis. Mol Med Rep. 2016 Nov;14(5):4075-4082. doi: 10.3892/mmr.2016.5767. Epub 2016 Sep 23.
- Background: PubMed 27086145Yin WJ, Xu HT, Sheng JG, An ZQ, Guo SC, Xie XT, Zhang CQ. Advantages of Pure Platelet-Rich Plasma Compared with Leukocyte- and Platelet-Rich Plasma in Treating Rabbit Knee Osteoarthritis. Med Sci Monit. 2016 Apr 17;22:1280-90. doi: 10.12659/msm.898218.
- Background: PubMed 26958322Smyth NA, Haleem AM, Ross KA, Hannon CP, Murawski CD, Do HT, Kennedy JG. Platelet-Rich Plasma May Improve Osteochondral Donor Site Healing in a Rabbit Model. Cartilage. 2016 Jan;7(1):104-11. doi: 10.1177/1947603515599190.
- Background: PubMed 26831629Smith PA. Intra-articular Autologous Conditioned Plasma Injections Provide Safe and Efficacious Treatment for Knee Osteoarthritis: An FDA-Sanctioned, Randomized, Double-blind, Placebo-controlled Clinical Trial. Am J Sports Med. 2016 Apr;44(4):884-91. doi: 10.1177/0363546515624678. Epub 2016 Feb 1.
- Derived from this study: PubMed 35103547Di Martino A, Boffa A, Andriolo L, Romandini I, Altamura SA, Cenacchi A, Roverini V, Zaffagnini S, Filardo G. Leukocyte-Rich versus Leukocyte-Poor Platelet-Rich Plasma for the Treatment of Knee Osteoarthritis: A Double-Blind Randomized Trial. Am J Sports Med. 2022 Mar;50(3):609-617. doi: 10.1177/03635465211064303. Epub 2022 Feb 1.
- Individual participant dataSharing planned: Yes
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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.
Berardo Di Matteo, MD study chair
I Clinic, Rizzoli Orthopaedic Institute, Bologna, Italy
Alessandro Di Martino, MD study chair
I Clinic, Rizzoli Orthopaedic Institute, Bologna, Italy
Francesco Tentoni, MD study chair
I Clinic, Rizzoli Orthopaedic Institute, Bologna, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Leukocyte-rich PRP intra-articular injections and Leukocyte-poor PRP intra-articular injections in people with Osteoarthritis, 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 2 inclusion and 7 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 4 Aug 2021. 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.
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?
IKDC (International knee documentation committee) score trend over time (time frame: basal (i.e. pre-treatment), 1 month, 2 months, 6 months and 12 months after treatment). 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 NCT02923700, which also lists 11 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 4 Aug 2021.