Range of Motion Clinical Trial
Official title:
Early Range of Motion Versus Plaster Immobilization After Open Reduction Internal Fixation of Elbow Fractures: A Prospective, Randomized Trial
NCT number | NCT05980312 |
Other study ID # | 19-196 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | December 27, 2019 |
Est. completion date | April 20, 2023 |
Verified date | July 2023 |
Source | The Cooper Health System |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 80 |
Est. completion date | April 20, 2023 |
Est. primary completion date | January 1, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Subjects must have undergone operative treatment for an elbow fracture - Operative indications for elbow fractures include: Type 13 humerus fractures including all subtypes, Type 2r1 radius fractures including all subtypes, Type 2u1 ulna fractures including all subtypes. - Individuals over the age of 18 years old. Exclusion Criteria: - Any patient who had not undergone operative treatment of an elbow fracture will be excluded. - Patients who were not treated surgically by an orthopaedic surgeon or were treated outside of the study frame will be excluded. - Individuals under the age of 18. - Pregnant women. - Patients admitted to the intensive care unit (ICU). - Patients with a history of trauma or injury to the affected elbow will be excluded. - Patients with extensive soft tissue injury of the elbow, which is defined as any injury that requires graft coverage, will be excluded. - Non-English speaking patients will be excluded. - Decisional-impaired patients will be excluded (as no substitute consent is requested). |
Country | Name | City | State |
---|---|---|---|
United States | Cooper University Health Care | Camden | New Jersey |
Lead Sponsor | Collaborator |
---|---|
The Cooper Health System |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | ASES-E Scores | A standardized elbow evaluation was developed by the Research Committee of the American Shoulder and Elbow Surgeons 1 (ASES). This score allows the evaluation of elbow function independently from the underlying diagnosis. | Preoperative and postoperatively as 2 weeks, 6 weeks, 3 months, 6 months, and 1 year | |
Primary | HSS Elbow Score | The Hospital for Special Surgery (HSS) scoring system 31 consists of eight domains described as pain, function, sagittal range, muscle strength, flexion contracture, extension contracture, pronation, and supination. | Preoperative and postoperatively as 2 weeks, 6 weeks, 3 months, 6 months, and 1 year | |
Primary | Range of Motion | Preoperative and postoperatively as 2 weeks, 6 weeks, 3 months, 6 months, and 1 year |
Status | Clinical Trial | Phase | |
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