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. 2022 Mar 3;2022(3):CD014328. doi: 10.1002/14651858.CD014328

Saeed 2015.

Study characteristics
Methods Study design: single centre, two‐arm, randomised controlled trial
Setting: Department of Orthopedics, Ch. Rehmat Ali Memorial Trust Hospital attached to Continental Medical College Lahore, Pakistan
Trial time period: January 2012 to December 2014
Interventions: arthroscopic surgery versus five intra‐articular hyaluronic acid injections given at weekly intervals
Sample size calculations: not reported
Analysis: intention‐to‐treat
Participants Number of participants
  • Number of participants screened: not reported

  • Number of participants at enrolment: 120

  • Number randomised: 120: 60 in the arthroscopic debridement group and 60 in the intra‐articular hyaluronic acid injection group

  • Number included in analyses: 120: 60 in the arthroscopic debridement group and 60 in the intra‐articular hyaluronic acid injection group


Inclusion criteria
  • Age > 40 years

  • History of pain in the knee joint

  • Grade 2 & 3 Kellgren‐Lawrence grading system


Exclusion criteria
  • Age < 40 years

  • History of injury or accident

  • Prior intervention with intra‐articular glucocorticoid injections within the past three months


Baseline characteristics
Arthroscopic surgery
  • No. (%) women: 48 (80)

  • No. (%) men: 12 (20)

  • No. (%) of Kellgren‐Lawrence Grade 2 ‐ 38 (63.33), Grade 3 ‐ 22 (36.66)

  • No. (%) Pain score measured on the Knee Society Score System (0 = severe, 50 = none): 10 = 4 (6.7), 20 = 42 (70), 30 = 14 (23.3)


Intra‐articular hyaluronic acid injections
  • No. (%) women: 50 (83.3)

  • No. (%) men: 10 (16.6)

  • No. (%) of Kellgren‐Lawrence Grade 2 ‐ 36 (60), Grade 3 ‐ 24 (40)

  • No. (%) Pain score measured on the Knee Society Score System (0 = severe, 50 = none): 10 = 8 (13.4), 20 = 26 (43.3), 30 = 26 (43.3)


Pre‐treatment group differences: there were some differences between groups in pain at baseline: in the intra‐articular hyaluronic acid injection group, 13% of participants had pain score 10, 43% had 20 and 43% had 30, while in the arthroscopic group, 7% of participants had pain score 10, 70% had 20 and 23% had 30.
Interventions Arthroscopic surgery
Arthroscopic debridement. Participants were admitted to the hospital, arthroscopic debridement was performed in the operation theatre by using two portals in all cases under spinal anaesthesia. Participants were discharged on the next day. Monitoring of electrocardiogram (ECG) and blood pressure was standard in all cases during the entire duration of the procedure. All the debridements were done by a single surgeon to minimise the bias for the study.
Intra‐articular hyaluronic acid injections
Participants were injected with intra‐articular hyaluronic acid after being given intradermal anaesthesia. The injections were given weekly for five weeks with a 24‐gauge needle under strict aseptic conditions in the operation theatre as an outpatient. In case of joint effusion, aspiration was done before the injection to prevent dilution of the injection.
Outcomes Outcome were assessed at baseline and at 1, 3 and 6 months' follow‐up
Outcomes
  • Knee Society Score System (KSSS) assessing knee pain scores; range from 0 ‐ severe to 50 ‐ none. This study categorised the scores into KSSS 20, KSSS 30, KSSS 40, KSSS 45

  • Adverse events


Outcomes used in this review at 3 and 6 months
  • Pain measured on KSSS, score 30 or higher

  • Total adverse events

Notes Funding: not reported
Trial registration: not reported
Adverse events:
Arthroscopic debridement group
Serious adverse events: none reported
Other adverse events:
No.(%): 13 (26)
Nature of event: pain and mild effusion
Total adverse events: No.(%): 13 (26)
Intra‐articular hyaluronic acid injection group
Serious adverse events: none reported
Other adverse events:
No.(%): 8 (13.4)
Nature of event: pain at injection site
Total adverse events: No.(%): 8 (13.4)
The frequency of adverse events in the arthroscopy group was higher than the injection group
Knee surgery (replacement or osteotomy): not reported
Progression of knee OA: not reported
Withdrawals: none
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Described as 'randomized experimental study' but no information about sequence generation process provided
Allocation concealment (selection bias) Unclear risk No information on whether allocation concealment was done or not
Blinding of participants and personnel (performance bias)
All outcomes High risk Blinding of participants and study personnel was not reported. Probably not done due to the nature of the intervention
Blinding of outcome assessor
Self‐reported outcomes High risk Risk of detection bias in assessment of participant‐reported knee pain and adverse events as blinding of participants was not reported but probably not done
Blinding of outcome assessor
Assessor‐reported outcome (knee replacement) Low risk Blinding of study personnel not reported but adverse effects unlikely to be influenced by lack of blinding
Incomplete outcome data (attrition bias)
All outcomes Low risk No withdrawals or loss to follow‐up
Selective reporting (reporting bias) High risk Trial registration not done and protocol not available. The authors measured overall knee function (using the Knee Society Score System), but it is unclear if they reported overall scores or a pain subscore.
Other bias Low risk No other bias apparent