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This was a prospective, multicenter, randomized, open-label, phase IV trial to compare the efficacy of supplementation with plasma proteins, hydrolyzed collagen (CH), a complex of HA-CS (HC-15), and vitamin C combined with a standard rehabilitation protocol versus the standard rehabilitation protocol only after arthroscopically-assisted functional ACL reconstruction with hamstrings.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PROGEN Group | Active Comparator | PROGEN + Standard Rehabilitation + ACL reconstruction |
|
| Control Group | No Intervention | Standard Rehabilitation + ACL reconstruction |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PROGEN | Dietary Supplement | Dietary supplement based on plasma proteins, hydrolyzed collagen, a complex of Hyaluronic Acid - Chondroitin Sulfate (HC-15), and vitamin C |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain improvement | Assessed using a 100-mm Visual Analog Scale (VAS) | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Knee function | Assessed using the International Knee Documentation Committee (IKDC) index. The final score was interpreted as a measure of function, with higher scores representing higher levels of function | 90 days |
| Analgesic consumption |
| Measure | Description | Time Frame |
|---|---|---|
| Perceived efficacy and tolerability by both patients and physicians | Perceived efficacy and tolerability were rated by both patients and physicians on a 5-point Likert scale, where higher scores indicated better efficacy and tolerability | 90 days |
| Safety |
Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30834280 | Derived | Lopez-Vidriero E, Olive-Vilas R, Lopez-Capape D, Varela-Sende L, Lopez-Vidriero R, Til-Perez L. Efficacy and Tolerability of Progen, a Nutritional Supplement Based on Innovative Plasma Proteins, in ACL Reconstruction: A Multicenter Randomized Controlled Trial. Orthop J Sports Med. 2019 Feb 27;7(2):2325967119827237. doi: 10.1177/2325967119827237. eCollection 2019 Feb. |
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| ID | Term |
|---|---|
| D000070598 | Anterior Cruciate Ligament Injuries |
| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D004966 | Estrogens, Conjugated (USP) |
| ID | Term |
|---|---|
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
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ACL parasagittal cuts were performed in T1 sequences and analyzed by a blinded musculoskeletal radiologist to improve the quality of the study
Analgesic consumption and frequency of analgesic intake during follow-up
| 90 days |
| Number of rehabilitation sessions required | Number of required rehabilitation sessions at the end of follow-up. | 90 days |
| Maduration of the graft | Assessed by MRI, by a single blind muskuloskeletal radiologist, using a standard procedure based on ACL oblique parasagittal T1 sequences | Day 0, day 90 |
Assessed by means of all adverse events (AE) treatment related, reported at the end of follow-up.
| 90 days |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |