Knee Chondral Lesion
Conditions
Keywords
PRP, AD-SVF, knee arthroscopy, cartilage, adipose tissue, microfracture, stromal vascular fraction
Brief summary
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.
Interventions
PROCEDUREBone Marrow Stimulation
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.
COMBINATION_PRODUCTstromal vascular fraction (SVF)
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.
DRUGPRP injection
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.
Sponsors
Arthrex GmbH
Università degli Studi dell'Aquila
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* knee pain and functional limitation for at least three months, monocompartmental chondral lesion \< 2 cm2, age over 18, and BMI between 18.5 and 30
Exclusion criteria
* previous major surgery on the same knee, concomitant chondral lesions in other knee compartments, being diagnosed with knee or hip osteoarthritis, knee instability, flexion deficit \> 20° or extension deficit \>15°, genu valgum or genu varum \> 20°, patients with Hb values \< 11 g/dL or platelet \< 150000/µL, patients in therapy with antiaggregants or anticoagulants or immunosuppressive agents, pregnancy, and the following comorbidities: hematological/neurologic/metabolic/rheumatic diseases, neoplastic disorders or history of local infections.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in knee clinical function questionnaire (KOOS) | From preoperatively (baseline) until the end of the study, up to 60 months. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Knee pain assessment | From preoperatively (baseline) until the end of the study, up to 60 months. | Pain intensity was measured using the Visual Analogue Scale (VAS). |
| Adverse events after the procedure | Until the end of the study, up to 60 months. | Adverse events such as knee swelling and pain with longer recovery time |
| Other Patient-Reported Outcome Measures | From preoperatively (baseline) to the end of the study, up to 60 months. | 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. |
Countries
Italy
Outcome results
None listed