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Trial record 2 of 9 for:    Rodeo

Routine Versus on Demand Removal of the Syndesmotic Screw (RODEO)

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ClinicalTrials.gov Identifier: NCT02896998
Recruitment Status : Recruiting
First Posted : September 12, 2016
Last Update Posted : July 3, 2019
Sponsor:
Information provided by (Responsible Party):
J.C. Goslings, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief Summary:
The objective of this trial is to demonstrate that the functional outcome of 'removal on demand' of the syndesmotic screw is non-inferior compared to routine removal of the syndesmotic screw in patients with an ankle fracture.

Condition or disease Intervention/treatment Phase
Anke Fracture Syndesmotic Injury Procedure: Removal on demand of the syndesmotic screw Procedure: Routine removal of fhe syndesmotic screw Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 193 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Routine Versus on Demand Removal of the Syndesmotic Screw
Study Start Date : January 2017
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : September 2020

Arm Intervention/treatment
Control group
The syndesmotic screw will routinely be removed 8 - 12 weeks following placement of the screw
Procedure: Routine removal of fhe syndesmotic screw
The syndesmotic screw will routinely be removed 8 - 12 weeks following placement of the screw

Experimental: Intervention
The syndesmotic screw will only be removed in case of symptomatic implants (e.g. implants causing pain or restricted range of motion)
Procedure: Removal on demand of the syndesmotic screw
The syndesmotic screw will only be removed in case of a symptomatic implant (e.g. implant causing pain or restricted range of motion)




Primary Outcome Measures :
  1. Functional outcome through the Olerud-Moland score [ Time Frame: 1 year following initial treatment ]

Secondary Outcome Measures :
  1. Functional outcome through the OAFAS [ Time Frame: 1 year following initial treatment ]
  2. Pain through the Visual Analog scale [ Time Frame: 1 year following initial treatment ]
  3. Range of motion [ Time Frame: 1 year following initial treatment ]
  4. Surgical complications [ Time Frame: 1 year following initial treatment ]
  5. Quality of Life through the EQ-5D-5L [ Time Frame: 1 year following initial treatment ]
  6. Health care consumption through the iMCQ [ Time Frame: 1 year following initial treatment ]
  7. Loss of productivity through the iPCQ [ Time Frame: 1 year following initial treatment ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Over 17 years of age
  • Placement of a metallic syndesmotic screw for an unstable ankle fracture or an isolated syndesmotic injury
  • Syndesmotic screw placed within two weeks of the trauma
  • Being in such condition that one is able to possibly undergo a second procedure

Exclusion Criteria:

  • ISS score >15
  • Injuries to the ipsi- and contralateral side which might hamper rehabilitation
  • Other medical conditions which hamper physical rehabilitation
  • Incomprehensive understanding of the Dutch language

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02896998


Locations
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Netherlands
Academic Medical Center Recruiting
Amsterdam, Noord-Holland, Netherlands, 1105AZ
Contact: Siem Dingemans, MD    +31 20 566 66 28    s.a.dingemans@amc.nl   
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: J.C. Goslings, Professor, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT02896998     History of Changes
Other Study ID Numbers: METC2016_197
First Posted: September 12, 2016    Key Record Dates
Last Update Posted: July 3, 2019
Last Verified: July 2019

Additional relevant MeSH terms:
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Ankle Injuries
Leg Injuries
Wounds and Injuries