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 - Cool-DIACF

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON44652

Enrollment

Registered

2015-10-29

Start date

2016-10-17

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

Calcaneal fracture

Interventions

Patients will be equally randomized to two groups: 1) Computer-controlled cooling brace 2) Pressure bandage

Eligibility

Age

18 Years to 99 Years

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 (8); confirmed on X-ray (lateral and AP with Brodèn view) or CT) 2. Indication for ORIF using an extended lateral or sinus tarsi 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 a 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 unfit 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

Measure	Time frame
Time to surgery	—

Secondary

Measure	Time 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	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)