|- candidate number||23565|
|- NTR Number||NTR5612|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||5-jan-2016|
|- Secondary IDs||MEC-2015-592 (METC Erasmus MC) NL54213.078.15|
|- Public Title||Effect of Computer-Controlled Cooling on Surgical Aspects after a Displaced Intra-Articular Calcaneal Fracture (Cool-DIACF); A Multicenter Randomized Controlled Trial|
|- Scientific Title||Effect of Computer-Controlled Cooling on Surgical Aspects after a Displaced Intra-Articular Calcaneal Fracture (Cool-DIACF); A Multicenter Randomized Controlled Trial|
|- hypothesis||We expect that preoperative and postoperative cooling will reduce swelling faster, reducing the time to surgery and time to discharge, respectively.|
|- Healt Condition(s) or Problem(s) studied||Displaced Intra-Articular Calcaneal Fracture (DIACF)|
|- Inclusion criteria||1. Patients with a displaced (>2 mm step-off in posterior facet), intra-articular calcaneal fracture (Sanders type II-IV or OTA type 82C2-4)|
2. Indication for ORIF using an extended lateral approach
3. Adult men or women aged 18 years or older
4. Hospital presentation within two days after trauma*
5. Provision of informed consent by patient
|- Exclusion criteria||1. Patients with an existing condition that result in asymmetrical morphometric characteristics of the distal part of either one of the lower legs |
2. Additional traumatic injuries that might influence extremity volume (e.g., lower extremity fracture, pelvic fracture)
3. Patients with bilateral calcaneal fractures
4. Patients with a pathological, recurrent, or open calcaneal fracture
5. Patients with decreased sensory function in any leg that might affect pain sensation.
6. Patients not fit for surgery
7. Patients unwilling or unable to comply with the intervention or follow-up visit schedule
8. Insufficient comprehension of Dutch or English language to understand rehabilitation programs and other treatment information in the judgment of the attending physician
9. Participation in another surgical intervention or drug study that might influence any of the outcome parameters
|- mec approval received||yes|
|- multicenter trial||yes|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jan-2016|
|- planned closingdate||30-jun-2018|
|- Target number of participants||36|
|- Interventions||Patients in the group will be treated with a computer-controlled cooling brace. The control group will receive a pressure bandage without cooling.|
|- Primary outcome||Time to surgery|
|- Secondary outcome||Preoperative and postoperative pain; Preoperative and postoperative swelling; Preoperative and postoperative foot/ankle circumference; Postoperative hospital length of stay; Satisfaction with the approach to reduce swelling; Adverse events within three months after surgery.|
|- Timepoints||Daily from hospital presentation until day 7 after surgery and at 2 weeks, 6 weeks, and 3 months after surgery.|
|- Trial web site||None|
|- CONTACT FOR PUBLIC QUERIES||Prof. Dr. Jack J.M. Dekker|
|- CONTACT for SCIENTIFIC QUERIES||MD PhD M.H.J. Verhofstad|
|- Sponsor/Initiator ||Erasmus MC, Trauma Research Unit department of Surgery, Erasmus Medical Center, Medical Ethical Committee (METC)|
(Source(s) of Monetary or Material Support)
|cCare Orthopedics B.V.|
|- Publications||None yet; study is ongoing|
|- Brief summary||BACKGROUND
Displaced intra-articular calcaneal fractures (DIACF) are challenging to treat and are associated with a long rehabilitation period. As the incidence shows a peak in persons in their wage-earning population, the burden to society is high. Surgery should be done as soon as possible. Timing of surgery is mostly determined by the amount of swelling that occurs after trauma. Swelling occurring after surgery may increase the risk of disturbed wound healing and prolong hospital length of stay. Cooling devices have been developed in order to reduce preoperative and postoperative swelling. Furthermore cooling may reduce the need for analgesics. Cooling is expected to result in earlier surgery, shorter hospital length of stay and earlier mobilization, which in turn reduces the risk of adverse events.
The primary aim of this study is to examine the effect of preoperative cooling versus pressure bandage on the time to surgery in adult patients who sustained a displaced intra-articular calcaneal fracture (DIACF) that will be treated operatively using an extended lateral approach.
The secondary aims are to examine in these patients:
1) the effect of preoperative and postoperative cooling versus pressure bandage on the level of preoperative and postoperative pain.
2) the effect of preoperative and postoperative cooling versus pressure bandage on preoperative and postoperative swelling.
3) the effect of preoperative and postoperative cooling versus pressure bandage on foot/ankle circumference.
4) the effect of postoperative cooling versus pressure bandage on postoperative hospital length of stay.
5) patient satisfaction with the approach to reduce swelling (cooling versus pressure bandage).
6) the effect of preoperative and postoperative cooling versus pressure bandage on the rate of complications.
Multicenter Randomized Controlled Trial (RCT)
Adult persons aged 18 years or older presenting to the Emergency Department with a unilateral, displaced, intra-articular calcaneal fracture (Sanders type III/V or OTA type 82C24), with an indication for treatment by open reposition and internal fixation (ORIF) using an extended lateral approach.
Patients will be equally randomized to two groups:
1) Computer-controlled cooling brace
2) Pressure bandage
Primary outcome measure: Time to surgery
Secondary outcome measures: Preoperative and postoperative pain; Preoperative and postoperative swelling; Preoperative and postoperative foot/ankle circumference; Postoperative hospital length of stay; Satisfaction with the approach to reduce swelling; Adverse events within three months after surgery
Data will be collected daily from hospital presentation until day 7 after surgery and at 2 weeks, 6 weeks, and 3 months after surgery.
|- Main changes (audit trail)|
|- RECORD||5-jan-2016 - 4-jan-2018|