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Choice of comparators

MP Manon Pigeolet
JS Jabbar Ghufran Syed
SA Sadia Ahmed
MC Muhammad Amin Chinoy
MK Mansoor Ali Khan
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The comparator chosen in this study to proof non-inferiority of the needle tenotomy technique is the gold standard 15-blade technique. We chose to compare with the gold standard to assure that participants in this trial receive appropriate care for their clubfoot and to avoid over-estimating the efficacy of the needle tenotomy. If non-inferiority of the needle tenotomy compared to the gold standard can be proven, we can assure that patients who would receive a needle tenotomy did not receive an inferior or mediocre care compared to the care that they could be receiving if they were to receive a tenotomy with a 15 blade.

We opted for a use of a 22-gauge needle, as described in our surgical technique adapted to low-resource settings [16]. A 22-gauge needle is readily available in the clubfoot clinic, of low cost, and will leave a smaller scar mark while still offering sufficient rigidity to safely cut the tendon.

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