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The role of pulsatile cold compression in edema resolution following ankle fractures: a randomized clinical trial
Mora S, Zalavras CG, Wang L, Thordarson DB
Foot & Ankle International 2002 Nov;23(11):999-1002
clinical trial
4/10 [Eligibility criteria: No; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: No; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

Twenty-four patients with displaced ankle fractures awaiting surgery were randomized to a study (n = 11) or a control group (n = 13). In the study group, patients had a pulsatile cold compression (PCC) device applied to their ankle, and remained at bed rest with the extremity elevated while awaiting surgery. In the control group patients remained in a posterior molded splint instead of the PCC device. Baseline circumferential measurements of the ankle were obtained, followed by measurements at 24-hour increments to evaluate edema resolution. In addition, patient satisfaction with use of the PCC device was evaluated with a scale ranging from 1 to 4. The median decrease of circumference in the study group compared to the control group was 0.5 cm versus 0.1 cm at 24 hours (p = 0.005), 0.9 cm versus 0.4 cm at 48 hours (p < 0.001), and 1.2 cm versus 0.5 cm at 72 hours (p = 0.009). The ratio of the decrease in circumference relative to the circumference of the normal ankle was significantly higher in the PCC group compared to the control group at all time points. All patients in the PCC group were satisfied with the device (median satisfaction score = 4). The PCC device was well tolerated and resulted in a significantly greater reduction of ankle circumference at 24, 48, and 72 hours after its application, compared to splinting and elevation alone. The PCC device facilitates edema resolution following ankle fractures.

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