Clinical Trials Logo

Clinical Trial Summary

Humeral shaft fractures represent 1-3% of all fractures and 20% of the humeral fractures. These fractures have historically been treated mainly conservatively with good results. Recent development in fracture treatment and findings that certain fracture types are more prone to non-union and bracing-related functional problems of adjacent joints are somewhat common have caused increasing interest in treating these fractures surgically. Return to activities is also considered to be quicker among surgically treated patients. The purpose of this study is to evaluate effectiveness and cost-effectiveness of surgical treatment of humeral shaft fractures. Patients with an unilateral humeral shaft fracture who are willing to participate in the study after informed consent are randomly assigned to two different treatment methods: 1. Surgical treatment with an open reduction and internal fixation with a 4,5mm locking plate. 2. Conservative treatment with functional bracing The randomization is done using blocked randomization (block sizes are not known by the enrolling or assigning physician) and stratification is done according to fracture type (AO-OTA type A vs. type B/C) and radial nerve status (total/subtotal motor palsy vs. no palsy). Standard follow-up visits at 6 weeks, 3, 6 and 12 months are arranged. Later follow-up visits are arranged at 2, 5 and 10 years for the study purpose. Patients fill evaluation forms and clinical and radiological assessments are made. The physiotherapist doing objective functional measurements is blinded to treatment method. Both study groups receive physiotherapy after the initial treatment.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT01719887
Study type Interventional
Source Töölö Hospital
Contact
Status Active, not recruiting
Phase N/A
Start date November 4, 2012
Completion date January 2028

See also
  Status Clinical Trial Phase
Withdrawn NCT04470895 - Impact of Drugs on the Risk of Falls in the Fracture Department of the Paris Saint-Joseph Hospital Group
Recruiting NCT02635022 - Fragility Fracture Liaison Service and Anti-osteoporosis Medication Monitoring Service Study
Unknown status NCT02013986 - Effects of Etomidate on Postoperative Circadian Rhythm Changes of Salivary Cortisol in Children Phase 4
Terminated NCT01248182 - Bone to Skin Thickness Study: Obese Versus Normal Population N/A
Recruiting NCT00969839 - NovaLign Intramedullary Fixation System (IFS) for the Treatment of Humeral Fractures Phase 4
Completed NCT00115180 - Racial and Ethnic Disparities in Acute Pain Control N/A
Completed NCT00520442 - Acute Pediatric Fracture Analgesia Study N/A
Not yet recruiting NCT06402292 - Surgical Treatment of Osteoarticular Infections Using Bioactive Bone Substitute N/A
Recruiting NCT04947722 - The PREVENT Trial: a Pragmatic Cluster Randomized Controlled Trial of a Multifaceted Fracture Prevention Model for Long-term Care N/A
Recruiting NCT06107699 - The CHARM Study-Coordinating Transitions From Hospital for Older Adults With Fractures N/A
Completed NCT04532580 - Clinical Validation of Boneview for FDA Submission
Completed NCT04237454 - Thermal Imaging Compared to Skeletal Survey in Children Below 2 Years N/A
Recruiting NCT05002335 - Clinical and Radiological Outcomes of Medacta Shoulder System (BE)
Completed NCT02591043 - Surgical Treatment of Low Energy Pelvic Fractures in the Elderly N/A
Completed NCT02933359 - Osteogenic Profiling of Normal Calvarial Bone
Completed NCT01049191 - Bone Microarchitecture in Women With and Without Fracture N/A
Completed NCT03431857 - Multi Centre Study on TESS V2 Shoulder System
Recruiting NCT04133103 - Early Mobilisation in the Surgical Robot Assisted Spinal Surgery N/A
Completed NCT03993691 - Wrist Fracture Evaluation With a Desktop Orthopedic Tomosynthesis System N/A
Completed NCT02786498 - Optimal Vitamin D3 Supplementation Strategies for Acute Fracture Healing Phase 2