PMID- 30834280
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220408
IS  - 2325-9671 (Print)
IS  - 2325-9671 (Electronic)
IS  - 2325-9671 (Linking)
VI  - 7
IP  - 2
DP  - 2019 Feb
TI  - Efficacy and Tolerability of Progen, a Nutritional Supplement Based on Innovative 
      Plasma Proteins, in ACL Reconstruction: A Multicenter Randomized Controlled 
      Trial.
PG  - 2325967119827237
LID - 10.1177/2325967119827237 [doi]
LID - 2325967119827237
AB  - BACKGROUND: New biologic strategies are arising to enhance healing and improve 
      the clinical outcome of anterior cruciate ligament (ACL) reconstruction. PURPOSE: 
      To evaluate the efficacy of a new oral nutritional supplement (Progen) that 
      contains hydrolyzed collagen peptides and plasma proteins, a hyaluronic 
      acid-chondroitin sulfate complex, and vitamin C. STUDY DESIGN: Randomized 
      controlled trial; Level of evidence, 2. METHODS: The study included patients who 
      underwent ACL reconstruction with hamstring autografts using the same fixation 
      method. All patients received the same analgesia and physical therapy (PT) 
      protocol and were randomized to receive either the nutritional supplement 
      (supplemented group) or no additional therapy (control group). Patients were 
      followed up at days 7, 30, 60, and 90. Pain was assessed by use of a visual 
      analog scale (VAS) and by analgesic consumption. Clinical outcome was assessed 
      via International Knee Documentation Committee (IKDC) score and the number of PT 
      sessions. Perceived efficacy and tolerability were rated on a 5-point Likert 
      scale. Graft maturation was assessed by a blinded musculoskeletal radiologist 
      using magnetic resonance imaging. The number of adverse events (AEs) was 
      recorded. RESULTS: The intention-to-treat analysis included 72 patients, 36 
      allocated to the supplemented group and 36 to the control group, with no 
      significant differences regarding demographic and preoperative characteristics. 
      Both groups showed significant improvement in pain and function (measured by VAS 
      and IKDC scores) during the 90-day follow-up period (P < .001 for both), without 
      significant differences between groups. The supplemented group had fewer patients 
      that needed analgesics (8.5% vs 50.0%; P < .05) and attended fewer PT sessions 
      (38.0 vs 48.4 sessions; P < .001) at 90 days and had a higher IKDC score at 60 
      days (62.5 vs 55.5; P = .029) compared with the control group. Patient- and 
      physician-perceived efficacy was considered significantly higher in the 
      supplemented group at 60 and 90 days (P < .05). Perceived tolerability of the 
      overall intervention was better in the supplemented group at 30, 60, and 90 days 
      (P < .05). Graft maturation showed more advanced degrees (grades 3 and 4) in the 
      supplemented group at 90 days (61.8% vs 38.2%; P < .01). No intolerance or AEs 
      associated with the nutritional supplement treatment were reported. CONCLUSION: 
      The combination of the nutritional supplement and PT after ACL reconstruction 
      improved pain, clinical outcome, and graft maturation. Nutritional 
      supplementation showed higher efficacy during the second month of recovery, 
      without causing AEs. REGISTRATION: NCT03355651 (ClinicalTrials.gov identifier).
FAU - Lopez-Vidriero, Emilio
AU  - Lopez-Vidriero E
AD  - ISMEC, Sevilla, Spain.
FAU - Olive-Vilas, Ramon
AU  - Olive-Vilas R
AD  - CST Consorci Sanitari de Terrassa, Barcelona, Spain.
FAU - Lopez-Capape, David
AU  - Lopez-Capape D
AD  - Clinica CEMTRO, Madrid, Spain.
FAU - Varela-Sende, Luisa
AU  - Varela-Sende L
AD  - OPKO Health, Barcelona, Spain.
FAU - Lopez-Vidriero, Rosa
AU  - Lopez-Vidriero R
AD  - ISMEC, Sevilla, Spain.
FAU - Til-Perez, Luis
AU  - Til-Perez L
AD  - CST Consorci Sanitari de Terrassa, Barcelona, Spain.
LA  - eng
SI  - ClinicalTrials.gov/NCT03355651
PT  - Journal Article
DEP - 20190227
PL  - United States
TA  - Orthop J Sports Med
JT  - Orthopaedic journal of sports medicine
JID - 101620522
PMC - PMC6393838
OTO - NOTNLM
OT  - anterior cruciate ligament tears
OT  - chondroitin sulfate
OT  - collagen
OT  - dietary supplementations
OT  - hyaluronic acid
OT  - platelet-rich plasma
OT  - vitamin C
COIS- One or more of the authors has declared the following potential conflict of 
      interest or source of funding: OPKO Health Spain SL provided financial support 
      for the conduct of the research. E.L.-V. and D.L.-C. have received financial 
      support for attending symposia as well as research support from OPKO. R.O.-V. has 
      received financial support for attending symposia from OPKO. L.V.-S. is a member 
      of the Clinical Research Department of OPKO. AOSSM checks author disclosures 
      against the Open Payments Database (OPD). AOSSM has not conducted an independent 
      investigation on the OPD and disclaims any liability or responsibility relating 
      thereto.
EDAT- 2019/03/06 06:00
MHDA- 2019/03/06 06:01
PMCR- 2019/02/27
CRDT- 2019/03/06 06:00
PHST- 2019/03/06 06:00 [entrez]
PHST- 2019/03/06 06:00 [pubmed]
PHST- 2019/03/06 06:01 [medline]
PHST- 2019/02/27 00:00 [pmc-release]
AID - 10.1177_2325967119827237 [pii]
AID - 10.1177/2325967119827237 [doi]
PST - epublish
SO  - Orthop J Sports Med. 2019 Feb 27;7(2):2325967119827237. doi: 
      10.1177/2325967119827237. eCollection 2019 Feb.