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Patients in knee cartilage studies unlike typical patients seen in the clinic
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 Cathrine Engen |
OSLO — Patients selected to be enrolled in trials studying treatment of knee cartilage defects involve so select a group that Norwegian researchers wonder whether those studies’ finding should be applied to the average individual with a knee cartilage defect.
“Results from RCTs (randomized controlled trials) are not representative of the population of patients with focal cartilage defects in the knee seen clinically,” Cathrine Engen, of the Oslo Sports Trauma Research Center, said here at the 2010 ESSKA Congress, where she presented a study that she and her colleagues conducted that involved a May 2009 search on Pub Med identifying 10 randomized controlled cartilage repair trials.
The researchers analyzed the studies for their most common inclusion criteria, which were a single lesion localized on the femoral condyle (of 4 cm2) in patients aged 18 to 40 years-old. They then compared those criteria to the demographics of patients seen at the Oslo Sports Trauma Research Center in 2008.
Variations seen
Engen and colleagues found 137 patients that matched the RCT’s criteria, but between 7% and 80% of them varied from criteria used in the trials, she noted.
After researchers eliminated one study because its lesion size criteria were too narrow, they matched 24.8% of the patients, Engen said, adding that a similarly designed study in the cardiac field found variations in study subjects compared with patients of 33% to 75%, which were comparable to her group’s findings.
“All our RCTs should try to be consistent in inclusion and exclusion criteria so there is consistency between the study population and the population you are trying to describe,” Engen said.
- Reference:
Engen C, Engebretsen L, Arøen A. Knee cartilage defect patients enrolled in randomized, controlled trials are not representative of patients in orthopaedic practice. Paper #FP14-570. Presented at the 14th ESSKA Congress. June 9-12, 2010. Oslo.
For this reason we need registries within cartilage repair and maybe also, in studies involving patients with less severe lesions leading to osteoarthritis, we should always include a nonoperated group.
– Gunnar Knutsen, MD
Department of
Orthopaedic Surgery, University Hospital
Tromsø, Norway
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