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Effect of Computer-Controlled Cooling on Surgical Aspects after a Displaced Intra-Articular Calcaneal Fracture (Cool-DIACF); A Multicenter Randomized Controlled Trial

Effect of Computer-Controlled Cooling on Surgical Aspects after a Displaced Intra-Articular Calcaneal Fracture (Cool-DIACF); A Multicenter Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON20937
Enrollment
36
Registered
2016-01-05
Start date
2016-01-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Displaced intra-articular calcaneal fracture (DIACF)

Interventions

Patients in the group will be treated with a computer-controlled cooling brace. The control group will receive a pressure bandage without cooling.

Sponsors

Erasmus MC, University Medical Center Rotterdam, Trauma Research Unit, Department of Surgery Erasmus Medical Center, Medical Research Ethics Committee (MREC)
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Time to surgery

Secondary

MeasureTime frame
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.

Contacts

Public ContactJack J.M. Dekker

Arkin

jack.dekker@arkin.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)