NCT02872753

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2017

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 19, 2016

Completed
11 months until next milestone

Study Start

First participant enrolled

July 11, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 11, 2017

Completed
5.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2023

Completed
Last Updated

May 10, 2023

Status Verified

September 1, 2022

Enrollment Period

1 month

First QC Date

August 16, 2016

Last Update Submit

May 9, 2023

Conditions

Meniscectomy

Keywords

Autologous Conditioned Plasmameniscectomyrandomized controlled trialintra-op injection

Outcome Measures

Primary Outcomes (2)

  • Change in IKDC (International Knee Documentation Committee) score over the various follow-up times

    basal, 15,30,60,180 days

  • Change in VAS( Visual Analogue score) for pain over the various follow-up times

    basal, 15,30,60,180 days

Secondary Outcomes (9)

  • Change in KOOS (Knee Injury and Osteoarthritis Outcome Score) over the various follow-up times

    basal, 15,30,60,180 days

  • Change in Tegner Score over the various follow-up times

    basal, 30,60,180 days

  • Change in transpatellar circumference over time

    basal, 15,30,60,180 days

  • Change in active and passive ROM

    basal, 15,30,60,180 days

  • Adverse events report

    15 days after surgery

  • +4 more secondary outcomes

Study Arms (2)

ACP GROUP

EXPERIMENTAL

Patients will receive a single intra-op ACP injection following a procedure of arthroscopic partial meniscectomy (medial or lateral)

Biological: ACP

CONTROL GROUP

OTHER

Patients will be treated by standard meniscectomy alone (medial or lateral)

Other: Standard Meniscectomy

Interventions

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

ACP GROUP
Standard MeniscectomyOTHER

Patients will receive standard arthroscopic meniscectomy

CONTROL GROUP

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • chronic symptomatic meniscal tears requiring partial resection;
  • healthy contra-lateral knee (i.e. no pain or functional limitation in the contra-lateral joint);

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rizzoli Orthopaedic Institute

Bologna, 40136, Italy

Location

Related Publications (12)

  • 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.

    PMID: 23863849BACKGROUND

  • Filardo 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.

    PMID: 25952818BACKGROUND

  • Heard 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.

    PMID: 26135713BACKGROUND

  • Thein 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.

    PMID: 20954664BACKGROUND

  • Filardo 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.

    PMID: 24275957BACKGROUND

  • Andia 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.

    PMID: 24080861BACKGROUND

  • Boswell 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.

    PMID: 22284405BACKGROUND

  • Lee 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.

    PMID: 26784189BACKGROUND

  • Blanke 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.

    PMID: 26605189BACKGROUND

  • Pujol 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.

    PMID: 25377191BACKGROUND

  • Griffin 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.

    PMID: 25663423BACKGROUND

  • Lo 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.

    PMID: 39425245DERIVED

Study Officials

  • Alessandro Di Martino, MD

    Nano-biotechnology Lab, Rizzoli Orthopaedic Institute, Bologna, Italy

    STUDY DIRECTOR

  • Giuseppe Filardo, MD

    Biomechanics Lab, Rizzoli Orthopaedic Institute, Bologna, Italy

    PRINCIPAL INVESTIGATOR

  • Berardo Di Matteo, MD

    Biomechanics Lab, Rizzoli Orthopaedic Institute, Bologna, Italy

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2016

First Posted

August 19, 2016

Study Start

July 11, 2017

Primary Completion

August 11, 2017

Study Completion

January 31, 2023

Last Updated

May 10, 2023

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)