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| ID | Type | Description | Link |
|---|---|---|---|
| EMEA-18060 | Other Grant/Funding Number | Arthrex GmbH |
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| Name | Class |
|---|---|
| Arthrex GmbH | INDUSTRY |
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The goal of this clinical trial is to learn if PRP and adipose-derived stem cells (AD-SVF) enhance healing after knee microfracture for chondral lesions. It will also learn about the safety of the procedure. The main questions it aims to answer are:
Do PRP and AD-SVF get better results than PRP alone in patients undergoing arthroscopic microfracture for knee monocompartmental cartilage injuries? What medical problems do participants have when taking drug ABC? Researchers will compare PRP + AD-SVF to PRP alone to see if PRP + AD-SVF work better to treat knee cartilage injuries.
Participants will:
Undergo knee microfracture and biologics injections at the end of the arthroscopic procedure (PRP+AD-SVF vs PRP).
Visit the clinic for checkups and tests at baseline and at 3, 6, 12 months post-treatment, and then annually.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRP | Active Comparator | In this arm, patients undergo arthroscopic microfracture of the chondral lesion and PRP injection. |
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| PRP + AD-SVF | Experimental | In this arm, patients undergo arthroscopic microfracture of the chondral lesion and PRP and AD-SVF injection. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bone Marrow Stimulation | Procedure | All patients underwent an arthroscopic procedure (that further confirmed the preoperative diagnosis; i.e. monocompartmental chondral lesion - Outerbridge grade IV) including a concomitant bone marrow stimulation technique (microfracture). According to the technique described by Steadman, the cartilaginous lesion underwent preliminary debridement to remove the damaged cartilage and form a stable edge of healthy tissue and subsequent microfracture with an arthroscopic pick to stimulate the subchondral unit regenerative response. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in knee clinical function questionnaire (KOOS) | Knee Injury Osteoarthritis Outcome Score is a self-administered questionnaire and assesses five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life. A Likert scale is used and all items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems) and each of the five scores is calculated as the sum of the items included. The resulting scores are then transformed to a scale from 0 to 100, with 0 representing extreme knee problems and 100 representing no knee problems. The scores on this scale represent the percentage of the total possible score that the person achieved. | From preoperatively (baseline) until the end of the study, up to 60 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Knee pain assessment | Pain intensity was measured using the Visual Analogue Scale (VAS). | From preoperatively (baseline) until the end of the study, up to 60 months. |
| Adverse events after the procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Salvatore Hospital | L’Aquila | Abruzzo | 67100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28619097 | Background | Bora P, Majumdar AS. Adipose tissue-derived stromal vascular fraction in regenerative medicine: a brief review on biology and translation. Stem Cell Res Ther. 2017 Jun 15;8(1):145. doi: 10.1186/s13287-017-0598-y. | |
| 36474791 | Background | Prodromidis AD, Charalambous CP, Moran E, Venkatesh R, Pandit H. The role of Platelet-Rich Plasma (PRP) intraarticular injections in restoring articular cartilage of osteoarthritic knees. A systematic review and meta-analysis. Osteoarthr Cartil Open. 2022 Nov 5;4(4):100318. doi: 10.1016/j.ocarto.2022.100318. eCollection 2022 Dec. |
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only IPD used in the results publication
Starting 6 months after publication
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Mar 25, 2019 | Nov 19, 2025 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D015775 | Fractures, Stress |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
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| stromal vascular fraction (SVF) | Combination Product | After bone marrow stimulation technique, patients were randomly assigned to one of the two treatment arms (allocation ratio 1:1). 40 patients underwent PRP injection while the other 40 underwent PRP + AD-SVF injections. |
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| PRP injection | Drug | After bone marrow stimulation technique, patients were randomly assigned to one of the two treatment arms (allocation ratio 1:1). 40 patients underwent PRP injection while the other 40 underwent PRP + AD-SVF injections. |
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Adverse events such as knee swelling and pain with longer recovery time
| Until the end of the study, up to 60 months. |
| Other Patient-Reported Outcome Measures | Overall physical and mental health-related quality of life was assessed with the 12-item Short Form Survey (SF-12). The SF-12 was constructed using questions drawn from each of the 8 dimensions of the MOS 36 item Short Form Survey (SF-36). It is designed to have similar performance to the SF-36, while taking less time to complete.Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). Additionally, the IKDC questionnaire was used to measure knee symptoms, functional limitations, and sports activity. An ordinal scoring system is used to assign a score of 0 to responses that signify the lowest level of function or the highest level of symptoms for each item. The IKDC Subjective Knee Evaluation Form is graded by adding the results of each item's scores, and then converting the result to a 0-100 scale. Higher scores indicate higher levels of function and lower levels of symptoms. | From preoperatively (baseline) to the end of the study, up to 60 months. |
| 36788843 | Background | Srinivasan V, Ethiraj P, Agarawal S, H S A, Parmanantham M. Comparison of Various Modalities in the Treatment of Early Knee Osteoarthritis: An Unsolved Controversy. Cureus. 2023 Jan 11;15(1):e33630. doi: 10.7759/cureus.33630. eCollection 2023 Jan. |
| 37360195 | Background | Cong B, Sun T, Zhao Y, Chen M. Current and Novel Therapeutics for Articular Cartilage Repair and Regeneration. Ther Clin Risk Manag. 2023 Jun 20;19:485-502. doi: 10.2147/TCRM.S410277. eCollection 2023. |
| 29525030 | Background | Welton KL, Logterman S, Bartley JH, Vidal AF, McCarty EC. Knee Cartilage Repair and Restoration: Common Problems and Solutions. Clin Sports Med. 2018 Apr;37(2):307-330. doi: 10.1016/j.csm.2017.12.008. |
| 26411978 | Background | Mirza MZ, Swenson RD, Lynch SA. Knee cartilage defect: marrow stimulating techniques. Curr Rev Musculoskelet Med. 2015 Dec;8(4):451-6. doi: 10.1007/s12178-015-9303-x. |