Karatosun 2008.
Methods | Randomised controlled trial, blinded, parallel group of 3 weeks. | |
Participants | 30 participants; 15 in HA group (mean age 52.1 (SD 11.3), 9 female, 6 male) and 15 in exercise group (mean age 58.1 (SD 12.1), 12 female, 3 male) Kellgren Lawrence III Osteoarthritis (OA) Ankle OA could be bilateral. | |
Interventions | HA intra‐articular 2.5 mg 3 weekly injections versus 6 weeks of daily exercise therapy | |
Outcomes | Primary outcome AOFAS score. Follow‐up 1, 2, 3 weeks and 2, 3, 6 and 12 months. Safety (recording of adverse effects), Pain and Physical function as described in the AOFAS: and separated in subsections: VAS testing motion, activity limitation, walking distance, walking surface, gait abnormality, sagittal motion. | |
Notes | Not clear if there was a minimum age required to be eligible for the study. Not described in Method section 43 ankles and 30 participants, some people had bilateral involvement No funding information available. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomization by drawing lots using a computer program |
Allocation concealment (selection bias) | Low risk | Well described process. participants were randomised by drawing lots using a computer program. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | It is very possible that participants told the therapist of the treatment they got. There is insufficient information to permit judgement of low risk or high risk of bias. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | It is possible that participants told the therapist of the treatment they got. There is insufficient information to permit judgement of low risk or high risk of bias. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing outcome data. |
Selective reporting (reporting bias) | Low risk | No selective outcome reporting. Outcome is consistent with method section. |
Other bias | Unclear risk | The group that was assigned to exercises had a significantly higher AOFAS score at baseline. Some participants had bilateral involvement of ankle OA which makes judgement of efficacy difficult. There is insufficient information to permit judgement of low risk or high risk of bias. |