MeniscectomyPhase 4ACP-MENNCT02872753
Intra-operative Injection of Autologous Conditioned Plasma (ACP) Following Partial Meniscectomy
A Phase 4 study testing ACP and Standard Meniscectomy in people with Meniscectomy, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
The aim of the present double blind controlled study is to evaluate the effects in terms of pain control and functional recovery provided by a single intra-operative injection of ACP performed at the end of arthroscopic partial meniscectomy. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Meniscectomy
- What is being tested?
- ACP and Standard Meniscectomy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteItaly
- Study dates
- 11 Jul 2017to 31 Jan 2023
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- chronic symptomatic meniscal tears requiring partial resection;
- healthy contra-lateral knee (i.e. no pain or functional limitation in the contra-lateral joint);
Who cannot join
- meniscal lesions requiring suture;
- previous surgery on the index knee;
- other concurrent articular lesion requiring surgical treatment (e.g.: cartilage or ligament injuries);
- history of knee infectious arthritis;
- concurrent rheumatic, metabolic or severe systemic disease;
- Body Mass Index (BMI) > 30;
- known hypersensibility or allergy to/towards HA ;
- alcohol or other substances abuse/excess.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intra-operative ACP Injection Following Partial Meniscectomy: a Randomized Controlled Trial
The aim of the present double blind controlled study is to evaluate the effects in terms of pain control and functional recovery provided by a single intra-operative injection of ACP performed at the end of arthroscopic partial meniscectomy.
Patients included in this trial will be randomized in two treatment groups: the first one will receive a single injection of 3-5 cc of ACP (using a dedicated centrifuge) at the end of the arthroscopic meniscectomy, whereas the second group will be treated by surgery alone. In order to ensure the double blinding of the trial all the patients enrolled will undergo blood harvesting before anesthesia, and acp will be produced just for the patients included in ACP group.
Read more
All patients will be evaluated basally, and then at 15, 30, 60, and 180 days after surgery by the following evaluation tools: IKDC (International Knee Documentation Committee) subjective, VAS (Visual Analogue Score) for pain, EQ-VAS for general Health Status, KOOS (Knee Injury and Osteoarthritis Outcome Score) and Tegner score. Furthermore, during the basal evaluation and at each follow-up visit up to 2 months, active and passive Range of Motion (ROM) of both the operated and contralateral knee were documented; also in addition, the trans-patellar circumference of both knees was registered to assess the trend of knee swelling over time.
Drugs assumption during the follow-up period will be recorded for each patient. All eventual adverse events occurred during the follow-up period will be registered.
- Conditions
- Meniscectomy
- Being tested
- ACP, Standard Meniscectomy
- Keywords
- Autologous Conditioned Plasma, meniscectomy, randomized controlled trial, intra-op injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACPBiological
Autologous Conditioned Plasma will be obtained directly in the operatory room from the peripheral venous blood of the patient, and injected intra-articularly at the end of arthroscopic meniscectomy
Standard MeniscectomyOther
Patients will receive standard arthroscopic meniscectomy
| Study group | Role | What they receive |
|---|---|---|
| ACP GROUP | Experimental | Patients will receive a single intra-op ACP injection following a procedure of arthroscopic partial meniscectomy (medial or lateral) Receives: Biological: ACP |
| CONTROL GROUP | Other | Patients will be treated by standard meniscectomy alone (medial or lateral) Receives: Other: Standard Meniscectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in IKDC (International Knee Documentation Committee) score over the various follow-up times
Measured: basal, 15,30,60,180 days
Change in VAS( Visual Analogue score) for pain over the various follow-up times
Measured: basal, 15,30,60,180 days
Secondary outcomes (9)
Change in KOOS (Knee Injury and Osteoarthritis Outcome Score) over the various follow-up times
Measured: basal, 15,30,60,180 days
Change in Tegner Score over the various follow-up times
Measured: basal, 30,60,180 days
Change in transpatellar circumference over time
Measured: basal, 15,30,60,180 days
Change in active and passive ROM
Measured: basal, 15,30,60,180 days
Adverse events report
Measured: 15 days after surgery
Adverse events report
Measured: 30 days after surgery
Adverse events report
Measured: 60 days after surgery
Adverse events report
Measured: 180 days after surgery
Change in VAS for general health status
Measured: basal, 30,60,180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2016 (estimated)
- Study start11 Jul 2017
- Primary completion11 Aug 2017
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for MeniscectomyStudies 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, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alessandro Di Martino, MD, Study director, Nano-biotechnology Lab, Rizzoli Orthopaedic Institute, Bologna, ItalyGiuseppe Filardo, MD, Principal investigator, Biomechanics Lab, Rizzoli Orthopaedic Institute, Bologna, ItalyBerardo Di Matteo, MD, Study chair, Biomechanics Lab, Rizzoli Orthopaedic Institute, Bologna, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02872753
- Sponsor's protocol ID
- ACP-MEN
- Acronym
- ACP-MEN
- Status last verified
- Sep 2022
- First submitted
- 16 Aug 2016
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abrams GD, Frank RM, Gupta AK, Harris JD, McCormick FM, Cole BJ. Trends in meniscus repair and meniscectomy in the United States, 2005-2011. Am J Sports Med. 2013 Oct;41(10):2333-9. doi: 10.1177/0363546513495641. Epub 2013 Jul 17.
PubMed 23863849Filardo G, Di Matteo B, Di Martino A, Merli ML, Cenacchi A, Fornasari P, Marcacci M, Kon E. Platelet-Rich Plasma Intra-articular Knee Injections Show No Superiority Versus Viscosupplementation: A Randomized Controlled Trial. Am J Sports Med. 2015 Jul;43(7):1575-82. doi: 10.1177/0363546515582027. Epub 2015 May 7.
PubMed 25952818Heard BJ, Barton KI, Chung M, Achari Y, Shrive NG, Frank CB, Hart DA. Single intra-articular dexamethasone injection immediately post-surgery in a rabbit model mitigates early inflammatory responses and post-traumatic osteoarthritis-like alterations. J Orthop Res. 2015 Dec;33(12):1826-34. doi: 10.1002/jor.22972. Epub 2015 Jul 7.
PubMed 26135713Thein R, Haviv B, Kidron A, Bronak S. Intra-articular injection of hyaluronic acid following arthroscopic partial meniscectomy of the knee. Orthopedics. 2010 Oct 11;33(10):724. doi: 10.3928/01477447-20100826-11.
PubMed 20954664Filardo G, Kon E, Roffi A, Di Matteo B, Merli ML, Marcacci M. Platelet-rich plasma: why intra-articular? A systematic review of preclinical studies and clinical evidence on PRP for joint degeneration. Knee Surg Sports Traumatol Arthrosc. 2015 Sep;23(9):2459-74. doi: 10.1007/s00167-013-2743-1. Epub 2013 Nov 26.
PubMed 24275957Andia I, Maffulli N. Platelet-rich plasma for managing pain and inflammation in osteoarthritis. Nat Rev Rheumatol. 2013 Dec;9(12):721-30. doi: 10.1038/nrrheum.2013.141. Epub 2013 Oct 1.
PubMed 24080861Boswell SG, Cole BJ, Sundman EA, Karas V, Fortier LA. Platelet-rich plasma: a milieu of bioactive factors. Arthroscopy. 2012 Mar;28(3):429-39. doi: 10.1016/j.arthro.2011.10.018. Epub 2012 Jan 28.
PubMed 22284405Lee HR, Shon OJ, Park SI, Kim HJ, Kim S, Ahn MW, Do SH. Platelet-Rich Plasma Increases the Levels of Catabolic Molecules and Cellular Dedifferentiation in the Meniscus of a Rabbit Model. Int J Mol Sci. 2016 Jan 16;17(1):120. doi: 10.3390/ijms17010120.
PubMed 26784189Blanke F, Vavken P, Haenle M, von Wehren L, Pagenstert G, Majewski M. Percutaneous injections of Platelet rich plasma for treatment of intrasubstance meniscal lesions. Muscles Ligaments Tendons J. 2015 Oct 20;5(3):162-6. doi: 10.11138/mltj/2015.5.3.162. eCollection 2015 Jul-Sep.
PubMed 26605189Pujol N, Salle De Chou E, Boisrenoult P, Beaufils P. Platelet-rich plasma for open meniscal repair in young patients: any benefit? Knee Surg Sports Traumatol Arthrosc. 2015 Jan;23(1):51-8. doi: 10.1007/s00167-014-3417-3. Epub 2014 Nov 7.
PubMed 25377191Griffin JW, Hadeed MM, Werner BC, Diduch DR, Carson EW, Miller MD. Platelet-rich plasma in meniscal repair: does augmentation improve surgical outcomes? Clin Orthop Relat Res. 2015 May;473(5):1665-72. doi: 10.1007/s11999-015-4170-8. Epub 2015 Feb 6.
PubMed 25663423Lo Presti M, Costa GG, Agro G, Vasco C, Boffa A, Di Martino A, Andriolo L, Cenacchi A, Zaffagnini S, Filardo G. Platelet-Rich Plasma Injections Do Not Improve the Recovery After Arthroscopic Partial Meniscectomy: A Double-Blind Randomized Controlled Trial. Am J Sports Med. 2024 Nov;52(13):3198-3205. doi: 10.1177/03635465241283052. Epub 2024 Oct 18.
PubMed 39425245
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-operative ACP Injection Following Partial Meniscectomy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02872753
- Acronym / sponsor ID
- ACP-MEN / ACP-MEN
- Conditions
- Meniscectomy
- Keywords
- Autologous Conditioned Plasma, meniscectomy, randomized controlled trial, intra-op injection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 11 Jul 2017 (actual)
- Primary completion
- 11 Aug 2017 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 19 Aug 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.
The aim of the present double blind controlled study is to evaluate the effects in terms of pain control and functional recovery provided by a single intra-operative injection of ACP performed at the end of arthroscopic partial meniscectomy.
Patients included in this trial will be randomized in two treatment groups: the first one will receive a single injection of 3-5 cc of ACP (using a dedicated centrifuge) at the end of the arthroscopic meniscectomy, whereas the second group will be treated by surgery alone. In order to ensure the double blinding of the trial all the patients enrolled will undergo blood harvesting before anesthesia, and acp will be produced just for the patients included in ACP group.
All patients will be evaluated basally, and then at 15, 30, 60, and 180 days after surgery by the following evaluation tools: IKDC (International Knee Documentation Committee) subjective, VAS (Visual Analogue Score) for pain, EQ-VAS for general Health Status, KOOS (Knee Injury and Osteoarthritis Outcome Score) and Tegner score. Furthermore, during the basal evaluation and at each follow-up visit up to 2 months, active and passive Range of Motion (ROM) of both the operated and contralateral knee were documented; also in addition, the trans-patellar circumference of both knees was registered to assess the trend of knee swelling over time.
Drugs assumption during the follow-up period will be recorded for each patient. All eventual adverse events occurred during the follow-up period will be registered.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACP GROUP | Experimental | Biological: ACPPatients will receive a single intra-op ACP injection following a procedure of arthroscopic partial meniscectomy (medial or lateral) |
| CONTROL GROUP | Other | Other: Standard MeniscectomyPatients will be treated by standard meniscectomy alone (medial or lateral) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- chronic symptomatic meniscal tears requiring partial resection;
- healthy contra-lateral knee (i.e. no pain or functional limitation in the contra-lateral joint);
Key exclusion criteria (8 listed)
- meniscal lesions requiring suture;
- previous surgery on the index knee;
- other concurrent articular lesion requiring surgical treatment (e.g.: cartilage or ligament injuries);
- history of knee infectious arthritis;
- concurrent rheumatic, metabolic or severe systemic disease;
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 |
|---|---|---|
| ACPAutologous Conditioned Plasma will be obtained directly in the operatory room from the peripheral venous blood of the patient, and injected intra-articularly at the end of arthroscopic meniscectomy | Biological | ACP GROUP |
| Standard MeniscectomyPatients will receive standard arthroscopic meniscectomy | Other | CONTROL GROUP |
Primary outcome
Change in IKDC (International Knee Documentation Committee) score over the various follow-up times
Time frame: basal, 15,30,60,180 days
Change in VAS( Visual Analogue score) for pain over the various follow-up times
Time frame: basal, 15,30,60,180 days
9 secondary outcomes
Change in KOOS (Knee Injury and Osteoarthritis Outcome Score) over the various follow-up times
Time frame: basal, 15,30,60,180 days
Change in Tegner Score over the various follow-up times
Time frame: basal, 30,60,180 days
Change in transpatellar circumference over time
Time frame: basal, 15,30,60,180 days
Change in active and passive ROM
Time frame: basal, 15,30,60,180 days
Adverse events report
Time frame: 15 days after surgery
Adverse events report
Time frame: 30 days after surgery
Adverse events report
Time frame: 60 days after surgery
Adverse events report
Time frame: 180 days after surgery
Change in VAS for general health status
Time frame: basal, 30,60,180 days
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 10 May 2023.
- Background: PubMed 23863849Abrams GD, Frank RM, Gupta AK, Harris JD, McCormick FM, Cole BJ. Trends in meniscus repair and meniscectomy in the United States, 2005-2011. Am J Sports Med. 2013 Oct;41(10):2333-9. doi: 10.1177/0363546513495641. Epub 2013 Jul 17.
- Background: PubMed 25952818Filardo G, Di Matteo B, Di Martino A, Merli ML, Cenacchi A, Fornasari P, Marcacci M, Kon E. Platelet-Rich Plasma Intra-articular Knee Injections Show No Superiority Versus Viscosupplementation: A Randomized Controlled Trial. Am J Sports Med. 2015 Jul;43(7):1575-82. doi: 10.1177/0363546515582027. Epub 2015 May 7.
- Background: PubMed 26135713Heard BJ, Barton KI, Chung M, Achari Y, Shrive NG, Frank CB, Hart DA. Single intra-articular dexamethasone injection immediately post-surgery in a rabbit model mitigates early inflammatory responses and post-traumatic osteoarthritis-like alterations. J Orthop Res. 2015 Dec;33(12):1826-34. doi: 10.1002/jor.22972. Epub 2015 Jul 7.
- Background: PubMed 20954664Thein R, Haviv B, Kidron A, Bronak S. Intra-articular injection of hyaluronic acid following arthroscopic partial meniscectomy of the knee. Orthopedics. 2010 Oct 11;33(10):724. doi: 10.3928/01477447-20100826-11.
- Background: PubMed 24275957Filardo G, Kon E, Roffi A, Di Matteo B, Merli ML, Marcacci M. Platelet-rich plasma: why intra-articular? A systematic review of preclinical studies and clinical evidence on PRP for joint degeneration. Knee Surg Sports Traumatol Arthrosc. 2015 Sep;23(9):2459-74. doi: 10.1007/s00167-013-2743-1. Epub 2013 Nov 26.
- Background: PubMed 24080861Andia I, Maffulli N. Platelet-rich plasma for managing pain and inflammation in osteoarthritis. Nat Rev Rheumatol. 2013 Dec;9(12):721-30. doi: 10.1038/nrrheum.2013.141. Epub 2013 Oct 1.
- Background: PubMed 22284405Boswell SG, Cole BJ, Sundman EA, Karas V, Fortier LA. Platelet-rich plasma: a milieu of bioactive factors. Arthroscopy. 2012 Mar;28(3):429-39. doi: 10.1016/j.arthro.2011.10.018. Epub 2012 Jan 28.
- Background: PubMed 26784189Lee HR, Shon OJ, Park SI, Kim HJ, Kim S, Ahn MW, Do SH. Platelet-Rich Plasma Increases the Levels of Catabolic Molecules and Cellular Dedifferentiation in the Meniscus of a Rabbit Model. Int J Mol Sci. 2016 Jan 16;17(1):120. doi: 10.3390/ijms17010120.
- Background: PubMed 26605189Blanke F, Vavken P, Haenle M, von Wehren L, Pagenstert G, Majewski M. Percutaneous injections of Platelet rich plasma for treatment of intrasubstance meniscal lesions. Muscles Ligaments Tendons J. 2015 Oct 20;5(3):162-6. doi: 10.11138/mltj/2015.5.3.162. eCollection 2015 Jul-Sep.
- Background: PubMed 25377191Pujol N, Salle De Chou E, Boisrenoult P, Beaufils P. Platelet-rich plasma for open meniscal repair in young patients: any benefit? Knee Surg Sports Traumatol Arthrosc. 2015 Jan;23(1):51-8. doi: 10.1007/s00167-014-3417-3. Epub 2014 Nov 7.
- Background: PubMed 25663423Griffin JW, Hadeed MM, Werner BC, Diduch DR, Carson EW, Miller MD. Platelet-rich plasma in meniscal repair: does augmentation improve surgical outcomes? Clin Orthop Relat Res. 2015 May;473(5):1665-72. doi: 10.1007/s11999-015-4170-8. Epub 2015 Feb 6.
- Derived from this study: PubMed 39425245Lo Presti M, Costa GG, Agro G, Vasco C, Boffa A, Di Martino A, Andriolo L, Cenacchi A, Zaffagnini S, Filardo G. Platelet-Rich Plasma Injections Do Not Improve the Recovery After Arthroscopic Partial Meniscectomy: A Double-Blind Randomized Controlled Trial. Am J Sports Med. 2024 Nov;52(13):3198-3205. doi: 10.1177/03635465241283052. Epub 2024 Oct 18.
- 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. This study is not recruiting at the moment.
Alessandro Di Martino, MD study director
Nano-biotechnology Lab, Rizzoli Orthopaedic Institute, Bologna, Italy
Giuseppe Filardo, MD principal investigator
Biomechanics Lab, Rizzoli Orthopaedic Institute, Bologna, Italy
Berardo Di Matteo, MD study chair
Biomechanics Lab, 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 ACP and Standard Meniscectomy in people with Meniscectomy, 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 8 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 10 May 2023. 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?
Change in IKDC (International Knee Documentation Committee) score over the various follow-up times (time frame: basal, 15,30,60,180 days). The study lists 2 primary outcomes in all. 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 NCT02872753, which also lists 12 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 10 May 2023.