Improvement of clinical outcomes following ACL reconstructive surgery Surgery
Conditions
Interventions
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 p
Sponsors
Hampshire Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 150 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Subjective pain measured using a numerical pain rating scale at baseline and post-op days 0, 1, 7 and 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Satisfaction with the surgery measured using a 5-point Likert scale to respond to the question "Overall, how would you rate the early result of your ACL reconstruction?" with options ranging from "Terrible" to "Excellent" at postoperative days 0, 1, 7 and 14 2. Satisfaction with the cryotherapy measured using a 5-point Likert scale to respond to the question "Overall, how satisfied are you with the cryotherapy treatments you have received today?" with options ranging from "Very unsatisfied" to "Very satisfied" at postoperative days 0, 1, 7 and 14 3. Ease-of-use of Physiolab S1 device (experimental group only) measured using a 5-point Likert scale to respond to the question "Overall, how easy have you found the Physiolab S1 device to use?" with options ranging from "Very difficult" to "Very easy" at postoperative days 0, 1, 7 and 14 4. Complications measured using hospital records following each participant's 14th postoperative day 5. Protocol adherence measured using a self-reported log of cryotherapy treatment frequency, time, method, and settings (where relevant) recorded daily for the first 14 postoperative days. 6. Use-of-analgesia measured using a self-reported log of any analgesic medication taken (time, type, dosage) recorded daily for the first 14 postoperative days | — |
Countries
England, United Kingdom
Contacts
Public ContactJames Belsey
Outcome results
None listed