Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-26 @ 10:43 PM
Ignite Modification Date:
2025-12-26 @ 10:43 PM
NCT ID:
NCT05980312
Brief Summary:
The purpose of this study is to compare the safety and efficacy, defined as improved range of motion and functional outcome scores, of early elbow motion in the early (immediately post-op) and late postoperative periods (2 week post-op).
Detailed Description:
A prospective randomized clinical trial will be performed. Patients over the age of 18 undergoing operative fixation of an elbow fracture by a Cooper orthopaedic surgeon will be considered for study inclusion. Patients who are under the age of 18, pregnant, admitted to the ICU, have a history of trauma/injury to the joint, or extensive soft tissue injury as determined by the treating orthopaedic surgeon will be excluded from study participation. All surgeons listed as co-investigators on this study have agreed to participate. Surgeons who may want to handle postop care differently despite randomization were not listed as co-investigators on this study. All patients will undergo operative fracture fixation of the elbow, which is standard of care. The decision for operative treatment will be made prior to study participation based on fracture classification and the discretion of the orthopaedic trauma team. There are discrete indications for operative treatment of elbow fractures in the orthopaedic literature. These guidelines are based upon the AO/OTA fracture classifications. Operative indications for elbow fractures include: type 13 humerus fractures including all subtypes, type 2r1 radius fractures including all subtypes, and type 2u1 ulna fractures including all subtypes. After this decision is made, the patient will be considered for study inclusion. There will be two treatment groups. The control group will be immobilized in a splint for 2 weeks and will be allowed to resume unrestricted motion at 2 weeks postop. The experimental group will be allowed to use unrestricted motion immediately after surgery. Both groups will be followed up postoperatively to monitor for pain, range of motion, and elbow function as well as the presence of complications. Once there is adequate pain control and if there are no complications, the patient will be discharged. All patients will be instructed to follow up with their surgeon within 2 weeks. If patients do not follow-up with the surgeon in 2 weeks time, the research team will call the patient to monitor clinical progress. At the time of follow-up, all patients will be recommended to go to physical therapy.
Study:
NCT05980312
Study Brief:
Protocol Section:
NCT05980312