Closed Reduction vs ORIF vs Non-Operative Study of intra-articular calcaneal fractures.

Closed Reduction vs ORIF vs Non-Operative Study of intra-articular calcaneal fractures; a multicenter randomised controled trial.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON27035

Enrollment

150

Registered

2006-06-07

Start date

2006-07-01

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

None listed

Interventions

This study will randomise between: 1. the percutaneous, distraction, technique according to Forgon and Zadravecz, 2. Open Reduction and Internal Fixation via a lateral approach, and 3. conservative tr

Eligibility

Inclusion criteria

Inclusion criteria: 1. All patients, with a displaced intra-articular calcaneal fracture; 2. Between 18 and 70 years old; 3. Compos mentis; 4. Living in the Netherlands; 5. Giving informed consent.

Exclusion criteria

Exclusion criteria: 1. A fracture older than 14 days; 2. Grade III open fractures (Gustilo); 3. Patients with chronic substance abuse; 4. Homeless; 5. Non-ambulant patients; 6. ASA IV-V; 7. Partcipation in an other study.

Design outcomes

Primary

Measure	Time frame
The primary outcome measure is the AOFAS score.	—

Secondary

Measure	Time frame
Secondary outcome measures are the number of complications (infectious, osseous and osteosynthetic), returning to work, patient satisfaction (VAS) and quality of life (SF36) and the need for a secondary arthrodesis.	—

Contacts

Public ContactT. Schepers

University Medical Center Rotterdam Department of General Surgery and Traumatology, Room-303, PO Box 2040

T.Schepers@erasmusmc.nl

Outcome results