Os Calcis Fracture Clinical Trial
Official title:
Surgical vs. Conservative Treatment of Displaced Intra-articular Calcaneal Fractures: A Prospective, Randomized, Controlled Multicenter Trial
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.
Status | Completed |
Enrollment | 82 |
Est. completion date | December 1998 |
Est. primary completion date | January 1994 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 78 Years |
Eligibility |
Inclusion Criteria: - Patients presented with > 2mm DIACFs verified by axial and coronal computerized tomography (CT) scan were considered for inclusion Exclusion Criteria: - Peripheral neuro-vascular disease (signs and symptoms of ischemia or neuropathy), open fractures, uncontrolled diabetes mellitus and medical contra-indications to surgery. |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Sweden | Stockholms Fotkirurgklinik, Sophiahemmet | Stockholm |
Lead Sponsor | Collaborator |
---|---|
Agren, Per-Henrik, M.D. |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Primary | 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 | No |
Secondary | VAS of pain at rest and exertion | The investigators anticipate that there might be a change over time and want to investigate and describe it | 2 weeks,6 weeks,12 weeks,1 year, 3 years and 10 years post injury | No |
Secondary | AOFAS hindfoot scale | 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 | No |
Secondary | Olerud-Molander score | 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 | No |