Comparison of outcomes when using an ice pack or electronic cryocompression device following ACL reconstruction: a randomised controlled trial
Improvement of clinical outcomes following ACL reconstructive surgery
This study is a single-centre randomized controlled trial involving two groups with one receiving cryocompression treatments using a Physiolab S1 cryocompression device and the other group using ice packs and bandages as per the current standard-of-care in the host institution. Experimental group: Physiolab S1 cryocompression device treatment every 4 waking hours following surgery for the first 14 postoperative days. The device will apply 8 ℃ and 25-50 mmHg for 30 minutes at a time. Control group: Standard of care (ice packs and bandages) applied every 4 waking hours following surgery for the first 14 postoperative days. Treatments will each last for 30 minutes. Randomisation will be performed in advance of participant recruitment using a random number generator, where “1” represents the experimental group and “2” represents the control group.
1. Adult patients of the 3 participating surgeons 2. Scheduled for unilateral ACL reconstruction surgery Patients with any of the below relative contraindications for cryotherapy may be included in the study but will be closely monitored during and immediately following cryotherapy treatments. Any adverse events that are identified will result in the immediate cessation of treatment and removal of that patient from the study. Relative contraindications include: 1. Diabetes 2. A loss of sensation in the intended therapy area 3. Confirmed or suspected tissue infection in the treatment area 4. History of frostbite on the affected limb or therapy area 5. An unstable fracture in the treatment area 6. An unstable localised skin condition in the intended therapy area 7. Heart failure 8. Raynaud’s phenomenon or cold hypersensitivity
1. Undergoing additional ligament procedure(s) simultaneously 2. Cold urticaria/allergy 3. Known haematological condition that affects clotting 4. Regenerating nerves under the intended therapy area 5. Tissues affected by tuberculosis in the intended therapy area 6. Current or suspected deep vein thrombosis and/or pulmonary embolus 7. Nervous system damage causing muscle tightness with a reduced ability to stretch 8. Cognitive impairment/disabilities or communication barriers 9. Significantly impaired circulation in the intended therapy area 10. Chronic wounds near the intended therapy area 11. Malignant tumour in the affected limb or therapy area 12. Haemorrhaging tissue or any untreated haemorrhagic disorders