- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00907296
Study of Romosozumab (AMG 785) in Tibial Diaphyseal Fractures Status Post Intramedullary Nailing (STARTT)
A Multi-center, Randomized, Double Blind, Placebo-controlled Study of AMG 785 in Skeletally Mature Adults With a Fresh Unilateral Tibial Diaphyseal Fracture Status Post Definitive Fracture Fixation With an Intramedullary Nail
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Victoria
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Geelong, Victoria, Australia, 3220
- Research Site
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Parkville, Victoria, Australia, 3050
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Blagoevgrad, Bulgaria, 2700
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Pleven, Bulgaria, 5800
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Plovdiv, Bulgaria, 4002
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Ruse, Bulgaria, 7000
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Sofia, Bulgaria, 1527
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Alberta
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Red Deer, Alberta, Canada, T4N 6V7
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Ontario
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Ajax, Ontario, Canada, L1S 2J5
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Thunder Bay, Ontario, Canada, P7B 7C7
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Toronto, Ontario, Canada, M5C 1R6
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Waterloo, Ontario, Canada, N2J 1C4
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Windsor, Ontario, Canada, N9A 1E1
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Quebec
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Montreal, Quebec, Canada, H4J 1C5
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Montreal, Quebec, Canada, H3G 1A4
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Hvidovre, Denmark, 2650
- Research Site
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København NV, Denmark, 2400
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Ã…rhus C, Denmark, 8000
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Tallinn, Estonia, 11312
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Tartu, Estonia, 50410
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Lille, France, 59000
- Research Site
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Marseille, France, 13009
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Nantes Cedex 1, France, 44035
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Paris Cedex 12, France, 75571
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Aachen, Germany, 52074
- Research Site
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Hamburg, Germany, 20246
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Hannover, Germany, 30625
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Mannheim, Germany, 68165
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Muenster, Germany, 48149
- Research Site
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Athens, Greece, 12462
- Research Site
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Athens, Greece, 14561
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Larissa, Greece, 41110
- Research Site
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Patra, Greece, 26500
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Thessaloniki, Greece, 56429
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Hong Kong, Hong Kong
- Research Site
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New Territories, Hong Kong
- Research Site
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Budapest, Hungary, 1081
- Research Site
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Miskolc, Hungary, 3526
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Nyiregyhaza, Hungary, 4400
- Research Site
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Szeged, Hungary, 6725
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Gandhinagar, India, 382 428
- Research Site
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Mangalore, India, 575 001
- Research Site
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Nashik, India, 422 009
- Research Site
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Karnataka
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Bangalore, Karnataka, India, 560 054
- Research Site
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Bangalore, Karnataka, India, 560 034
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Mangalore, Karnataka, India, 575 002
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Maharashtra
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Pune, Maharashtra, India, 411 005
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Rajasthan
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Jaipur, Rajasthan, India, 302 022
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Tamil Nadu
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Madurai, Tamil Nadu, India, 625 020
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Firenze, Italy, 50139
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Milano, Italy, 20122
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Milano, Italy, 20142
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Pisa, Italy, 56126
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Roma (RM), Italy, 00133
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Verona, Italy, 37126
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Liepaja, Latvia, 3400
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Riga, Latvia, 1004
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Riga, Latvia, 1005
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Valmiera, Latvia, 4201
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Kaunas, Lithuania, 44320
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Vilnius, Lithuania, 04130
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Nuevo León
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Monterrey, Nuevo León, Mexico, 64040
- Research Site
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Christchurch, New Zealand, 8022
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Tauranga, New Zealand, 3143
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Kongsvinger, Norway, 2226
- Research Site
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Bialystok, Poland, 15-276
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Bytom, Poland, 41-902
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Krakow, Poland, 30-901
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Kraków, Poland, 31-826
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Lublin, Poland, 20-718
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Bucharest, Romania, 014461
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Bucuresti, Romania, 050098
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Timisoara, Romania, 300736
- Research Site
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Moscow, Russian Federation, 129327
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Moscow, Russian Federation, 115280
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Moscow, Russian Federation, 117292
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Moscow, Russian Federation, 127299
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Moscow, Russian Federation, 119049
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Saint Petersburg, Russian Federation, 196247
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Yaroslavl, Russian Federation, 150003
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Bratislava, Slovakia, 833 05
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Nitra, Slovakia, 950 01
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Piestany, Slovakia, 921 01
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Leeds, United Kingdom, LS1 3EX
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London, United Kingdom, E1 1BB
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Newcastle, United Kingdom, NE1 4LP
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Norwich, United Kingdom, NR4 7UY
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Oxford, United Kingdom, OX3 9DU
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Stanmore, United Kingdom, HA7 4LP
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Alabama
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Birmingham, Alabama, United States, 35294
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California
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Orange, California, United States, 92868
- Research Site
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Colorado
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Aurora, Colorado, United States, 80012
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Denver, Colorado, United States, 80204
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Florida
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Jacksonville, Florida, United States, 32209
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Indiana
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Indianapolis, Indiana, United States, 46202
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Michigan
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Detroit, Michigan, United States, 48202
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Missouri
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Saint Louis, Missouri, United States, 63110
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New York
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Brooklyn, New York, United States, 11220
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Rochester, New York, United States, 14642
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Pennsylvania
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Altoona, Pennsylvania, United States, 16602
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Philadelphia, Pennsylvania, United States, 19104
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South Carolina
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Columbia, South Carolina, United States, 29203
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Utah
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Sandy, Utah, United States, 84070
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Skeletally mature adults, age 18 to 85 years with radiographically closed growth plates
- Fresh unilateral closed or Gustilo type I or type II open tibial fracture
- Definitive fracture fixation with reamed (closed and open fractures) or unreamed (open fractures only) intramedullary nailing
Exclusion Criteria:
- Major polytrauma or significant axial trauma
- Associated lower extremity fracture that will delay subject's ability to bear weight beyond the normal time expected for a tibial shaft fracture
- Use of bone grafts at the time of fracture fixation
- Pathological fracture or metabolic or bone disease
- History of symptomatic spinal stenosis or facial nerve paralysis
- Malignancy within the last 5 years
- Evidence of the following (currently or within the past 5 years): elevated transaminases, significantly impaired renal function, current hyper- or hypocalcaemia
- Use of agents affecting bone metabolism
- Subject refuses to use appropriate methods of contraception
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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PLACEBO_COMPARATOR: Placebo
Participants received subcutaneous injections of matching placebo on day 1 and at weeks 2, 6, and 12.
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Administered by subcutaneous injection
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EXPERIMENTAL: Romosozumab 70 mg: 2 Doses
Participants received subcutaneous injections of 70 mg romosozumab on day 1 and week 2, and matching placebo at weeks 6 and 12.
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Administered by subcutaneous injection
Other Names:
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EXPERIMENTAL: Romosozumab 70 mg: 3 Doses
Participants received subcutaneous injections of 70 mg romosozumab on day 1 and weeks 2 and 6, and matching placebo at week 12.
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Administered by subcutaneous injection
Other Names:
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EXPERIMENTAL: Romosozumab 70 mg: 4 Doses
Participants received subcutaneous injections of 70 mg romosozumab on day 1 and weeks 2, 6, and 12.
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Administered by subcutaneous injection
Other Names:
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EXPERIMENTAL: Romosozumab 140 mg: 2 Doses
Participants received subcutaneous injections of 140 mg romosozumab on day 1 and week 2, and matching placebo at weeks 6 and 12.
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Administered by subcutaneous injection
Other Names:
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EXPERIMENTAL: Romosozumab 140 mg: 3 Doses
Participants received subcutaneous injections of 140 mg romosozumab on day 1 and weeks 2 and 6, and matching placebo at week 12.
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Administered by subcutaneous injection
Other Names:
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EXPERIMENTAL: Romosozumab 140 mg: 4 Doses
Participants received subcutaneous injections of 140 mg romosozumab on day 1 and weeks 2, 6, and 12.
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Administered by subcutaneous injection
Other Names:
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EXPERIMENTAL: Romosozumab 210 mg: 2 Doses
Participants received subcutaneous injections of 210 mg romosozumab on day 1 and week 2, and matching placebo at weeks 6 and 12.
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Administered by subcutaneous injection
Other Names:
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EXPERIMENTAL: Romosozumab 210 mg: 3 Doses
Participants received subcutaneous injections of 210 mg romosozumab on day 1 and weeks 2 and 6, and matching placebo at week 12.
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Administered by subcutaneous injection
Other Names:
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EXPERIMENTAL: Romosozumab 210 mg: 4 Doses
Participants received subcutaneous injections of 210 mg romosozumab on day 1 and weeks 2, 6, and 12.
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Administered by subcutaneous injection
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Time to Radiographic Healing
Time Frame: 52 weeks
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Time to radiographic healing was defined as the time from intramedullary (IM) nailing to the first occurrence of bridging of 3 out of 4 cortices. Radiographic fracture healing was determined by a panel of independent reviewers (orthopedic/trauma surgeons and radiologists) blinded to treatment. The cumulative incidence function (CIF) method was used to estimate the median time to radiographic healing and the confidence intervals. Unplanned revision surgery to promote healing was considered a competing risk in CIF estimate. |
52 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change From Week 8 in Short Form (36) Health Survey Physical Functioning Domain
Time Frame: Week 8 and weeks 12, 16, 20, 24, 36, and 52
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The Medical Outcome Study Short Form 36-Item Health Survey (SF-36), Version 2, is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The physical functioning domain includes 10 questions that assess limitations in physical activities because of health problems. Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. The range of SF-36 physical functioning is 14.94 - 57.03. Higher scores indicate a higher level of functioning. A positive change from baseline score indicates an improvement in physical functioning. |
Week 8 and weeks 12, 16, 20, 24, 36, and 52
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Number of Participants With Unplanned Revision Surgeries
Time Frame: 52 weeks
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52 weeks
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Time to Clinical Healing
Time Frame: 52 weeks
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Time to clinical healing was defined as the time from the IM nailing surgery date to the first date that both the score for ability to bear weight on the fractured limb and the score for absence of pain at the fracture site were equal to 6. The score for the ability to bear weight on the fractured limb was based on the ability to stand on affected leg without assistive device and the ability to walk without assistive device. The score ranges from 0 (unable to bear full body weight on the fractured limb) to 6 (able to bear full body weight on the fractured limb). Absence of pain at the fracture site was based on the absence of pain at the fracture site when applying direct pressure to the fracture site and applying a stress to the fracture site. The score ranges from 0 (pain without palpation at fracture site) to 6 (total absence of pain at fracture site). Time to clinical healing was estimated using CIF; unplanned revision surgery was considered a competing risk in CIF estimate. |
52 weeks
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20062017
- 2008-008392-34 (EUDRACT_NUMBER)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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