Moreland 1993.

Methods	Randomised Controlled Trial Double‐blind Blinded assessor Screen blinded pt Parallel‐group Multicentre (n=5) 4 wk washout of NSAID but permitted acetaminophen as analgesia. Analysis: ITT Phase I efficacy: per protocol Flare population: n=30 (31 knees)
Participants	Country: U.S.A. Mean age: NR % Female:67 Mean disease duration: NR Duration:34 wk Number randomised:94 (HA 46, AR 48) [104 knees: HA 52, AR 52] Inclusion: chronic idiopathic OA of knee confirmed by xray Kellgren and Lawrence Grade 2 to 4 in no more than 2 compartments symptoms of inflammation and/or advanced disease which included rest pain during day of at least moderate severity (>=40/ 100 mm VAS) or pain awakening them at night Exclusion: pregnant or of childbearing potential not using effective contraception varus or valgus deformity >=10o surgery on knee in past 3 mth or planning surgery chondromalacia as primary contributor to symptoms <18 y unavailable for 26 wk follow‐up RA, AS, gout, IBD, pseudogout, psoriatic arthritis, peripheral neuropathy causing pain or diastasis distal to knee metabolic disease associ‐ ated with joint abnormalities liver disease cancer diabetes mellitus, drug abuse Baseline values: pain with motion HA: 69, AR: 70
Interventions	Hylan G‐F 20 (2 ml) 3 weekly arthro‐ centeses followed by injection Arthrocentesis 3 weekly Concurrent therapy: Acetaminophen usage for analgesia documented (pill counts)
Outcomes	pain with walking, at rest, at night, with motion and overall ( 100 mm VAS) activity restriction joint tenderness (100 mm VAS) joint effusion (+/‐, volume) pt and evaluator global assess‐ ments (100 mm VAS) Assessments: Phase I Wk 0,2,4,5,6,8,10 Phase II Wk 10‐18,11‐19,12‐ 20,16‐22,18‐26, 26‐34
Notes	Jadad's:5/5 R‐2,B‐2,W‐1 If bilateral OA, both knees could be treated and evaluated. 10 pts had both knees treated ‐ (5 AR, 1 HA, 4 both) 34% patients presented with an effusion. Each knee randomised Arthrocentesis with removal of effusion if present. In Phase II, evaluated repeat treatment with a second course of three hylan G‐F 20 injections but no control group. Biomatrix, Inc. sponsored work.
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment (selection bias)	Low risk	A ‐ Adequate