| Methods |
Randomised
Controlled
Trial
Per protocol: n=36 |
| Participants |
Country:
France and Italy
Mean age: 62
% Female:67
Mean disease duration: 3 y
Duration: 1 y
Number randomised:39
(HA 20, CT 19)
Inclusion:
primary OA defined by ACR
clinical involvement of medial compartment
active disease justifying local therapy
absence of advanced disease (Kellgren and Lawrence Grade 4)
absence of contraindication of arthroscopy
presence of chondropathy of medial comparment at arthroscopy
Exclusion:
any IA surgery in past 5 y (including arthroscopy)
any IA treatment prescribed in past 3 mths
any concurrent
symptomatic treatment had to be stable for at least one mth before study
Baseline values:
pain
HA:49.2, CT:52.1
Lequesne
HA:8.9, CT:9.4
arthroscopy overall assessment
HA:41.8, CT:52.6
AIMS2
HA:2.6, CT:2.2
Joint space width (mm) HA: 4.5,
CT: 3.5
SFA scoring
HA: 26.1,
CT: 39.0 |
| Interventions |
Hyalgan (20 mg/2ml) 3 weekly injections every 3 mth for total of 9 injections with 1st injection 1 mth after arthroscopy and last 3 mth before final visit
Conventional therapy but all pts had arthroscopy with lavage 2 litres saline serum
before randomisation
Concurrent therapy: analgesics & NSAID
permitted |
| Outcomes |
arthroscopy scored MD overall assess‐
ment (100 mm VAS), revised SFA scoring and SFA grading‐‐‐‐‐‐‐
global pain 100 mm VAS
Lequesne Index
AIMS2
analgesic/NSAID score
AP wt bearing knee xrays ‐ joint space narrowing by 7‐grade and joint space width (mm) |
| Notes |
Jadad's:2/5
R‐1,B‐0,W‐1
Synovial fluid aspirated before injection.
Imbalance at entry in severity of chondropathy .
Imbalance in amount of rescue treatment.
Study supported by a grant from Fidia S.p.A. and in part from a grant from the Societe Francaise de Rhumatologie.
Hyalgan supplied by Fidia S.p.A. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Unclear risk |
B ‐ Unclear |
