Elbow FractureNCT05980312
Does Early Elbow Motion Improve Patient Outcomes After Surgically Treated Elbow Fractures?
A study testing Splint Immobilization and Early Motion in people with Elbow Fracture and Range of Motion, run by Cooper Norcross Health at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Elbow Fracture, Range of Motion, Immobilization
- What is being tested?
- Splint Immobilization and Early Motion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Dec 2019to 20 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Cooper University Health Care
Camden, New Jersey, 08103
About this study
Official title: Early Range of Motion Versus Plaster Immobilization After Open Reduction Internal Fixation of Elbow Fractures: A Prospective, Randomized Trial
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).
Read the 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.
- Conditions
- Elbow Fracture, Range of Motion, Immobilization
- Being tested
- Splint Immobilization, Early Motion
- Medical subject headings
- Elbow Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Splint ImmobilizationOther
Patients will be randomized to receive a splint following their surgical procedure.
Early MotionOther
Patients will be randomized to receive no splint following their surgical procedure.
| Study group | Role | What they receive |
|---|---|---|
| Immobilized | Active comparator | Patients in the control group will be immobilized for 2 weeks and resume unrestricted motion once the splint is taken off. Receives: Other: Splint Immobilization |
| Early Range of Motion | Experimental | Patients in the experimental group will start early motion immediately after surgery. Receives: Other: Early Motion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Preoperative and postoperatively as 2 weeks, 6 weeks, 3 months, 6 months, and 1 year
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.
Measured: Preoperative and postoperatively as 2 weeks, 6 weeks, 3 months, 6 months, and 1 year
Range of Motion
Measured: Preoperative and postoperatively as 2 weeks, 6 weeks, 3 months, 6 months, and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start27 Dec 2019
- Primary completion1 Jan 2023
- Study completion20 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elbow FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized clinical trial
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cooper Norcross Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Fuller, Cooper Norcross Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05980312
- Sponsor's protocol ID
- 19-196
- Status last verified
- Jul 2023
- First submitted
- 31 Jul 2023
- Last updated
- 7 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Range of Motion Versus Plaster Immobilization After Open Reduction Internal Fixation of Elbow Fractures: A Prospective, Randomized Trial
- ClinicalTrials.gov ID
- NCT05980312
- Acronym / sponsor ID
- 19-196
- Conditions
- Elbow Fracture, Range of Motion, Immobilization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Cooper Norcross HealthUniversity, hospital or other
- Study start
- 27 Dec 2019 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 20 Apr 2023 (actual)
- First posted
- 7 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Immobilized | Active comparator | Other: Splint ImmobilizationPatients in the control group will be immobilized for 2 weeks and resume unrestricted motion once the splint is taken off. |
| Early Range of Motion | Experimental | Other: Early MotionPatients in the experimental group will start early motion immediately after surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Splint ImmobilizationPatients will be randomized to receive a splint following their surgical procedure. | Other | Immobilized |
| Early MotionPatients will be randomized to receive no splint following their surgical procedure. | Other | Early Range of Motion |
Primary outcome
ASES-E Scores
Time frame: Preoperative and postoperatively as 2 weeks, 6 weeks, 3 months, 6 months, and 1 year
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.
HSS Elbow Score
Time frame: Preoperative and postoperatively as 2 weeks, 6 weeks, 3 months, 6 months, and 1 year
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.
Range of Motion
Time frame: Preoperative and postoperatively as 2 weeks, 6 weeks, 3 months, 6 months, and 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Splint Immobilization and Early Motion in people with Elbow Fracture and Range of Motion, run by Cooper Norcross Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ASES-E Scores (time frame: Preoperative and postoperatively as 2 weeks, 6 weeks, 3 months, 6 months, and 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2023.