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

NCT01615744 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 82

Last updated 2012-06-11

No results posted yet for this study

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

Interventions

PROCEDURE

Open Reduction Internal Fixation

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

PROCEDURE

Non-surgical management

Early active exercises and elevation to decrease swelling

Sponsors & Collaborators

  • Agren, Per-Henrik, M.D.

    lead INDIV

Principal Investigators

  • Per-Henrik Aagren, MD · Consultant Orthopaedic Surgeon

Eligibility

Min Age
18 Years
Max Age
78 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1993-12-31
Primary Completion
1994-01-31
Completion
1998-12-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01615744 on ClinicalTrials.gov