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NCT00609479 Clinical Trial

Comparison of Two Methods for Treatment of Colles´s Fracture

Distal Radius Fracture Clinical Trial

Official title:
Comparison of External and Internal Fixationmethods for Distal Radius Fracture - a Randomized Study.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00609479
Other study ID # JOS-1
Secondary ID JOS-1
Status Completed
Phase N/A
First received January 24, 2008
Last updated April 9, 2010
Start date January 2008
Est. completion date February 2010

Study information
Verified date April 2010
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority Denmark: The Danish National Committee on Biomedical Research Ethics
Study type Interventional

Clinical Trial Summary

The purpose of this study is to compare two different fixationmethods for fractures of the wrist(distal radius fractures). We are comparing an external fixation (Hoffmann-II-non-bridging) vs. an internal fixation(Micronail). Primary endpoint is patient satisfaction as scored by the DASH-questionnaire.Secondary followup is X-rays, strength, PRWE-questionnaire.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date February 2010
Est. primary completion date February 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Fracture Older type 2.

- Fracture Older type 3.

Exclusion Criteria:

- Fractures older than 3 weeks.

- Pregnancy.

- Seq. after previous fracture.

- Distal fragments volar cortex < 10 mm.

- Open fracture larger than Gustillo 1.

- Disability due to other illness.

- Congenital abnormity or injury/disease in the affected extremity.

- Not capable of mentally/physically to cooperate.

- Not able to go to followup on the operating hospital.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Osteosynthesis
Micronail osteosynthesis. A cast for the first 14 days, thereafter starting physiotherapy. Control at weeks 1,2,5,12. Hoffmann-II-non-bridging osteosynthesis. Removal of device after 5 weeks. physiotherapy starts at 14 days. Control at weeks 1,2,5,12.

Locations
Country Name City State
Denmark Regionhospital Herning Herning
Denmark Regionhospital Holstebro Holstebro
Denmark Regionhospital Viborg Viborg

Sponsors (1)
Lead Sponsor Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary DASH-questionnaire 3 months No
Secondary PRWE-questionnaire 3 months No
See also
  Status Clinical Trial Phase
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Completed NCT04554472 - Usefulness of Intraoperative Ultrasound in a Volar Plate Distal Radius Fixation
Completed NCT03613922 - Effects of Early Manual Therapy on Functional Outcomes After Volar Plating of Distal Radius Fractures N/A
Completed NCT01823692 - Evaluating Validity of Ultrasonography in Determining Distal Radius Fracture Reduction Phase 2
Completed NCT02286661 - Short-Arm Casting Effective in Type A2 Fractures in the Distal Radius N/A
Completed NCT01062997 - Volar Locked Plating Versus Bridging External Fixation N/A
Not yet recruiting NCT04100317 - Spanning Bridged Plate in Comminuted Distal Radius Fractures
Recruiting NCT04976335 - Quantitative and Clinical Assessment of Flexor Tendon Gliding Following Application of a Bioresorbable Hydrogel: A Prospective, Randomized Study in Patients Undergoing Distal Radius Fracture Repair N/A
Completed NCT03635060 - Distraction Osteogenesis for Distal Radius Fractures vs. Volar Plating N/A
Not yet recruiting NCT05095415 - Occupational Therapy Pre-operative Education in the Orthopedic Hand Setting N/A
Terminated NCT02744352 - Single Shot vs Catheter Infraclavicular Brachial Plexus Block After Distal Radius Fracture Repair N/A
Completed NCT05558306 - Radiological vs Clinical Outcome in DRF N/A
Completed NCT01778673 - Cortical Comminution and Intra-articular Involvement in Distal Radius Fractures Can Predict Radiological Outcome. A Prospective Multicenter Study N/A
Active, not recruiting NCT03349216 - Bier's Block Versus Systemic Analgesia Phase 2
Completed NCT04357470 - Manual Dexterity in Ulnar Styloid Fracture Patients N/A
Completed NCT05360836 - The Effect of Motor Imagery in Patients With Radius Distal End Fracture N/A
Recruiting NCT02957240 - Graded Motor Imagery for Women at Risk for Developing Type I CRPS Following Closed Treatment of Distal Radius Fractures N/A
Completed NCT03240471 - Cast OFF Trial: One Versus Four-five Weeks of Plaster Cast Immobilization N/A
Terminated NCT04089709 - Well-arm Exercise in Distal Radius Fractures N/A
Completed NCT05623865 - The Effect of Kinesio Taping on Edema Control and Wrist Functions in Conservatively Followed Distal Radius Fractures. N/A

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