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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02531750 |
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Date of registration:
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06/03/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Metabolic Complications Following Achilles Tendon Rupture - A Cohort Study
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Scientific title:
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Metabolic Complications Following Achilles Tendon Rupture - A Cohort Study |
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Date of first enrolment:
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June 2015 |
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Target sample size:
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14 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02531750 |
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Study type:
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Observational |
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Study design:
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Phase:
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N/A
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Kristoffer W Barfod, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hvidovre University Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Individuals of age 18 to 70 years
- Rupture of Achilles tendon happened within 5 days.
- The patient must be expected to be able to attend rehabilitation and
post-examinations.
- The patient must be able to speak and understand Danish.
- The patient must be able to give informed consent.
Exclusion Criteria:
- Former rupture of one or both Achilles tendon(s)
- Previous surgery on the Achilles tendon
- Fluoroquinolone treatment within the last 6 months
- Tendinosis treated with corticosteroids (tablets or injections) within the last 6
months.
- The patient has been diagnosed with arterial insufficiency in the legs.
- Terminal illness or severe medical illness: ASA score higher than or equal to 3.
- The space between the rupture and the calcaneus is less than 1cm.
- BMI >/= 35 kg/m2
- Known diabetes mellitus or HbA1c >/= 48 mol/mol
- Clinical significant anaemia, liver or kidney disease as judged by the sponsor or
principal investigator.
- Thyroid function abnormality (TSH < 0.1 or TSH > 10)
- Calcium metabolic derangement, Ca++ < 1.1 or Ca++ > 1.40
- Known osteoporosis
- Re-rupture of the Achilles tendon between week 8 and 52
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Achilles Tendon Rupture
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Immobilization
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Intervention(s)
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Other: Immobilization due to an Achilles tendon rupture
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Primary Outcome(s)
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Glucose metabolism
[Time Frame: Metabolic derangement: 0 to 8 weeks]
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Bone metabolism
[Time Frame: Metabolic derangement: 0 to 8 weeks]
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Lipid metabolism
[Time Frame: Metabolic derangement: 0 to 8 weeks]
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Atherosclerotic markers
[Time Frame: Metabolic derangement: 0 to 8 weeks]
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Secondary Outcome(s)
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Atherosclerotic markers: Lipoproteins, immune response and low grade inflammation
[Time Frame: Metabolic derangement: 8 weeks; Metabolic restoration 52 weeks]
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Bone metabolism
[Time Frame: Metabolic derangement: 8 weeks; Metabolic restoration 52 weeks]
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Lipid metabolism
[Time Frame: Metabolic derangement: 8 weeks; Metabolic restoration 52 weeks]
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Glucose metabolism
[Time Frame: Metabolic derangement: 8 weeks; Metabolic restoration 52 weeks]
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Secondary ID(s)
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ATR_ORTHOMED
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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