Surgical vs Conservative Treatment of Displaced Intra-articular Calcaneal Fractures: A Prospective RCT

NCT01615744 | Completed

• 1 other identifier: CalcanealfxRCT
• Study Type: observational
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

Between 1994-98 5 hospitals in Stockholm investigated calcaneal fractures in a randomised study. 82 patients were included and randomized either to non-surgical treatment or surgical management with extensile lateral approach and reduction with Internal fixation (ORIF) The patients were followed and investigated at fixed intervals 2 weeks, 8 weeks, 3 months and 6 months for clinical review. At 1 year and 8-12 years (mean 10 years) post-injury. Both clinical radiological data were collected and several scores were used. The primary outcomes scores used were SF-36 and VAS score. The results after 1 year and mean 10 years are presented.

Conditions

Os Calcis Fracture

Keywords

calcaneal fractures; surgical treatment; conservative treatment; VAS scoring; SF-36; AOFAS; Olerud-Molander score; outcome

Outcome Measures

Primary Outcomes (2)

• SF-36

  The investigators anticipate that there might be a change over time and want to investigate and describe it

  1 year and 10 years post injury

• VAS-score (calcaneal fractures) /Hildebrand, Buckley

  The investigators anticipate that there might be a change over time and want to investigate and describe it

  1 year and 10 years post injury

Secondary Outcomes (3)

• VAS of pain at rest and exertion

  2 weeks,6 weeks,12 weeks,1 year, 3 years and 10 years post injury

• AOFAS hindfoot scale

  1 year and 10 years post injury

• Olerud-Molander score

  1 year and 10 years post injury

Study Arms (2)

Surgical ORIF calcaneal fx

Procedure: Open Reduction Internal Fixation

Conservative treatment calcaneal fx

Procedure: Non-surgical management

Interventions

Open Reduction Internal Fixation PROCEDURE

Lateral approach through extensile lateral incision ( Benirschke), Reduction ( Soeur et Remy) and internal fixation with lateral plating with or without bone graft

Also known as: Surgery

Surgical ORIF calcaneal fx

Non-surgical management PROCEDURE

Early active exercises and elevation to decrease swelling

Also known as: No surgery, early movement, decreasing swelling

Conservative treatment calcaneal fx

Eligibility Criteria

• Age: 18 Years - 78 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Between 1994 and 1998. Patients presenting at 5 hospitals in Stockholm after trauma resulting in a fracture with \> 2mm Dislocated Intraarticular Calcaneal Fractures (DIACFs) verified by axial and coronal computerized tomography (CT) scan were considered for inclusion

You may not qualify if:

• Peripheral neuro-vascular disease (signs and symptoms of ischemia or neuropathy), open fractures, uncontrolled diabetes mellitus and medical contra-indications to surgery.

Sponsors & Collaborators

• Agren, Per-Henrik, M.D.: lead

Study Sites (1)

Stockholms Fotkirurgklinik, Sophiahemmet

Stockholm, 11486, Sweden

Location

MeSH Terms

Interventions

Surgical Procedures, Operative

Study Officials

• Per-Henrik Aagren, MD

  Consultant Orthopaedic Surgeon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDIV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2012
• First Posted: June 11, 2012
• Study Start: December 1, 1993
• Primary Completion: January 1, 1994
• Study Completion: December 1, 1998
• Last Updated: June 11, 2012

Record last verified: 2012-06

Locations

SE (1)