PMID- 27250845
OWN - NLM
STAT- MEDLINE
DCOM- 20171214
LR  - 20220409
IS  - 1471-2474 (Electronic)
IS  - 1471-2474 (Linking)
VI  - 17
DP  - 2016 Jun 1
TI  - Evidence for safety of retreatment with a single intra-articular injection of 
      Gel-200 for treatment of osteoarthritis of the knee from the double-blind pivotal 
      and open-label retreatment clinical trials.
PG  - 240
LID - 10.1186/s12891-016-1101-0 [doi]
LID - 240
AB  - BACKGROUND: Gel-200 is a cross-linked hyaluronate single-injection device for 
      treatment of osteoarthritis pain in the knee. This report summarizes new analyses 
      of the safety of retreatment with Gel-200 from the 13-week, pivotal, multicenter, 
      randomized controlled trial (RCT) followed by an open-label extension trial 
      (OLE). METHODS: 379 patients were enrolled in the RCT [Gel-200; 
      phosphate-buffered saline (PBS)]. Safety of retreatment with Gel-200 was assessed 
      by comparing adverse events (AEs) and device-related AEs reported through Week 4 
      following retreatment with Gel-200 to those reported in patients receiving their 
      first injection in the OLE. RESULTS: 350 patients completed the initial RCT (231 
      Gel-200; 119 PBS); 258 patients enrolled in the OLE (162 Gel-200; 96 PBS). In 
      total, 202 patients (125 Gel-200; 77 PBS) qualified for retreatment, while 56 (37 
      Gel-200; 19 PBS) did not. There were no significant demographic or disease 
      characteristic differences between Gel-200 patients who were and were not 
      retreated; those who were not eligible for retreatment experienced greater pain 
      relief from Gel-200 in the RCT by all effectiveness endpoints (all p < 0.001), 
      without differences in their safety profile. In the OLE, the safety of Gel-200, 
      including percentages of patients who experienced any AEs (p = 0.547) and 
      device-related AEs (p = 0.521), did not significantly differ between those 
      receiving a second versus a first injection of Gel-200 following PBS in the RCT. 
      CONCLUSION: In the OLE, the safety of a second injection of Gel-200 was 
      comparable to that of a first injection and effectiveness was similar, as 
      previously reported. TRIAL REGISTRATION: ClinicalTrials.gov identification 
      numbers NTC 00449696 and NTC 00450112.
FAU - Strand, Vibeke
AU  - Strand V
AD  - Division of Immunology and Rheumatology, Stanford University School of Medicine, 
      Palo Alto, CA, USA.
FAU - Lim, Sooyeol
AU  - Lim S
AD  - North American Business Unit, Seikagaku Corporation, Chiyoda-ku, Tokyo, Japan.
FAU - Takamura, Junko
AU  - Takamura J
AD  - Clinical Development Department, Research & Development Division, Seikagaku 
      Corporation, Chiyoda-ku, Tokyo, Japan. junko.takamura@seikagaku.co.jp.
LA  - eng
SI  - ClinicalTrials.gov/NCT00449696
SI  - ClinicalTrials.gov/NCT00450112
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20160601
PL  - England
TA  - BMC Musculoskelet Disord
JT  - BMC musculoskeletal disorders
JID - 100968565
RN  - 0 (Viscosupplements)
RN  - 9004-61-9 (Hyaluronic Acid)
SB  - IM
MH  - Aged
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Hyaluronic Acid/*administration & dosage
MH  - Injections, Intra-Articular
MH  - Male
MH  - Middle Aged
MH  - Osteoarthritis, Knee/*drug therapy
MH  - Viscosupplements/*administration & dosage
PMC - PMC4888617
OTO - NOTNLM
OT  - Cross-linked HA
OT  - Gel-200
OT  - Hyaluronic acid
OT  - Intra-articular
OT  - Knee
OT  - Osteoarthritis
OT  - Viscosupplementation
EDAT- 2016/06/03 06:00
MHDA- 2017/12/15 06:00
PMCR- 2016/06/01
CRDT- 2016/06/03 06:00
PHST- 2015/10/15 00:00 [received]
PHST- 2016/05/27 00:00 [accepted]
PHST- 2016/06/03 06:00 [entrez]
PHST- 2016/06/03 06:00 [pubmed]
PHST- 2017/12/15 06:00 [medline]
PHST- 2016/06/01 00:00 [pmc-release]
AID - 10.1186/s12891-016-1101-0 [pii]
AID - 1101 [pii]
AID - 10.1186/s12891-016-1101-0 [doi]
PST - epublish
SO  - BMC Musculoskelet Disord. 2016 Jun 1;17:240. doi: 10.1186/s12891-016-1101-0.