Distal Humerus FracturesNCT04376801
A Retrospective Study on the Outcome of Different Fixation Methods After Olecranon Osteotomy
An observational study of Distal Humerus Fractures and Osteotomy, run by Beijing Jishuitan Hospital at 1 site in China.
Trial summary
Humeral intercondylar fractures are very challenging in clinical treatment. There are many problems not clear. One of the important problems remained to be solved is which fixation method can achieve the best effects after olecranon osteotomy. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Distal Humerus Fractures, Osteotomy, Fixation Device; Complications
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2012to 31 Mar 2021
- Phase
- Observational
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients who were operated in our hospital because of distal humerus fractures in 2012-2017.
Who may be able to join
- Patients over 18 years old;
- Distal humerus fractures.
Who cannot join
- Pathological fractures;
- Combined with fractures of ipsilateral upper limb;
- Fracture over 2 weeks;
- Patients who refused surgical treatment;
- Patients who were unable to obtain the 1 year follow-up data after the operation.
Trial locations and contacts
1 site in 1 country.
About this study
Humeral intercondylar fractures are very challenging in clinical treatment. There are many problems not clear. One of the important problems remained to be solved is which fixation method can achieve the best effects after olecranon osteotomy. Therefore, the investigators are going to perform a retrospective analysis of patients with distal humerus fractures admitted to their hospital in 2012-2017 to compare the functional outcomes of elbow joints with tension-band fixation and plate fixation after olecranon osteotomy.
Read the detailed description
Humeral intercondylar fractures are very challenging in clinical treatment. Because the humeral intercondylar fracture is comminuted and often occurs in elderly patients with osteoporosis, it is difficult to achieve rigid fixation during the operation and failure of fixation occurs from time to time after the operation. Nonunion and reoperation have brought great sufferings to the patients.In recent years, both surgical methods and technique of internal fixation have been greatly improved, but there are still many problems not clear. Olecranon osteotomy has been proven to be an effective approach for comminuted intercondylar fractures and there are different fixation methods to fix the proximal ulna after intercondylar fixation. However, it is not clear which method can achieve the best effects. Therefore, the investigators are going to perform a retrospective analysis of patients with distal humerus fractures admitted to their hospital in 2012-2017 to compare the functional outcomes of elbow joints with tension-band fixation and plate fixation after olecranon osteotomy.
- Keywords
- Distal Humerus Fractures, Olecranon Osteotomy, Plate Fixation, Tension-band Fixation
- Medical subject headings
- Humeral Fractures, Distal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Tension-band Fixation Group | Patients with distal humerus fractures admitted to our hospital in 2012-2017 who had been performed open reduction and internal fixation through olecranon osteotomy approach were selected. All patients were devided into two groups by different fixation method. Patients who had been performed tension-band fixation after olecranon osteotomy were classified into Tension-band Fixation Group. | |
| Plate Fixation Group | Patients with distal humerus fractures admitted to our hospital in 2012-2017 who had been performed open reduction and internal fixation through olecranon osteotomy approach were selected. All patients were devided into two groups by different fixation method. Patients who had been performed plate fixation after olecranon osteotomy were classified into Plate Fixation Group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional result of elbow (objective)
Assess function of patients' affected elbow by MEPS (Mayo elbow performance score)
Measured: 1 year post-op
Functional result of elbow (subjective)
Assess function of patients' affected elbow by and DASH (Disabilities of arm, shoulder and hand)
Measured: 1 year post-op
Range of motion of elbow
Measure and record the ROM of the affected elbow，including flexion, extension, pronation and supination degree.
Measured: 1 year post-op
Secondary outcomes (8)
Complication: infection
Record patients' information about infection if any, including superficial and deep infection.
Measured: 1 year post-op
Complication:stiffness
Record whether the patients had elbow stiffness (ROM<100° or arthrolysis having been performed)
Measured: 1 year post-op
Complication: internal fixation irritation
Record whether there were internal fixation irritations
Measured: 1 year post-op
Complication: failure of internal fixation
Record whether the patients have gone through internal fixation failure
Measured: 1 year post-op
Complication: post-traumatic arthritis
Record if the patients have developed into post-traumatic arthritis, if any, record the degree.
Measured: 1 year post-op
severity of ulnar nerve injury
Assess and record severity of ulnar nerve injury (paralysis or weakness of intrinsic muscle of hand or parathesia of ring and little finger)
Measured: 1 year post-op
severity of pain
Assess severity of pain by VAS (Visual analogue scale)
Measured: 1 year post-op
nounion
Record if there is nonunion of the olecranon (evaluated by X-ray or CT scan)
Measured: 1 year post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2020
- Study start1 Dec 2012
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Humerus FracturesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Jishuitan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen chen, Beijing Jishuitan Hospital
- Investigators
- Xieyuan Jiang, Principal investigator, Beijing Jishuitan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04376801
- Sponsor's protocol ID
- 201708-05
- Status last verified
- May 2020
- First submitted
- 25 Jan 2020
- Last updated
- 6 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study on the Outcome of Different Fixation Methods After Olecranon Osteotomy
- ClinicalTrials.gov ID
- NCT04376801
- Acronym / sponsor ID
- 201708-05
- Keywords
- Distal Humerus Fractures, Olecranon Osteotomy, Plate Fixation, Tension-band Fixation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Beijing Jishuitan HospitalUniversity, hospital or other
- Study start
- 1 Dec 2012 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Mar 2021 (estimated)
- First posted
- 6 May 2020 (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.
Humeral intercondylar fractures are very challenging in clinical treatment. There are many problems not clear. One of the important problems remained to be solved is which fixation method can achieve the best effects after olecranon osteotomy. Therefore, the investigators are going to perform a retrospective analysis of patients with distal humerus fractures admitted to their hospital in 2012-2017 to compare the functional outcomes of elbow joints with tension-band fixation and plate fixation after olecranon osteotomy.
Detailed description
Humeral intercondylar fractures are very challenging in clinical treatment. Because the humeral intercondylar fracture is comminuted and often occurs in elderly patients with osteoporosis, it is difficult to achieve rigid fixation during the operation and failure of fixation occurs from time to time after the operation. Nonunion and reoperation have brought great sufferings to the patients.In recent years, both surgical methods and technique of internal fixation have been greatly improved, but there are still many problems not clear. Olecranon osteotomy has been proven to be an effective approach for comminuted intercondylar fractures and there are different fixation methods to fix the proximal ulna after intercondylar fixation. However, it is not clear which method can achieve the best effects. Therefore, the investigators are going to perform a retrospective analysis of patients with distal humerus fractures admitted to their hospital in 2012-2017 to compare the functional outcomes of elbow joints with tension-band fixation and plate fixation after olecranon osteotomy.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tension-band Fixation Group | – | –Patients with distal humerus fractures admitted to our hospital in 2012-2017 who had been performed open reduction and internal fixation through olecranon osteotomy approach were selected. All patients were devided into two groups by different fixation method. Patients who had been performed tension-band fixation after olecranon osteotomy were classified into Tension-band Fixation Group. |
| Plate Fixation Group | – | –Patients with distal humerus fractures admitted to our hospital in 2012-2017 who had been performed open reduction and internal fixation through olecranon osteotomy approach were selected. All patients were devided into two groups by different fixation method. Patients who had been performed plate fixation after olecranon osteotomy were classified into Plate Fixation Group. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who were operated in our hospital because of distal humerus fractures in 2012-2017.
Key inclusion criteria (2 listed)
- Patients over 18 years old;
- Distal humerus fractures.
Key exclusion criteria (5 listed)
- Pathological fractures;
- Combined with fractures of ipsilateral upper limb;
- Fracture over 2 weeks;
- Patients who refused surgical treatment;
- Patients who were unable to obtain the 1 year follow-up data after the operation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Functional result of elbow (objective)
Time frame: 1 year post-op
Assess function of patients' affected elbow by MEPS (Mayo elbow performance score)
Functional result of elbow (subjective)
Time frame: 1 year post-op
Assess function of patients' affected elbow by and DASH (Disabilities of arm, shoulder and hand)
Range of motion of elbow
Time frame: 1 year post-op
Measure and record the ROM of the affected elbow，including flexion, extension, pronation and supination degree.
8 secondary outcomes
Complication: infection
Time frame: 1 year post-op
Complication:stiffness
Time frame: 1 year post-op
Complication: internal fixation irritation
Time frame: 1 year post-op
Complication: failure of internal fixation
Time frame: 1 year post-op
Complication: post-traumatic arthritis
Time frame: 1 year post-op
severity of ulnar nerve injury
Time frame: 1 year post-op
severity of pain
Time frame: 1 year post-op
nounion
Time frame: 1 year post-op
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2020.
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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.
Xieyuan Jiang principal investigator
Beijing Jishuitan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Distal Humerus Fractures and Osteotomy, run by Beijing Jishuitan Hospital at 1 site in China.
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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 6 May 2020. 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 China. 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?
Results are not available in the source record.
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?
Functional result of elbow (objective) (time frame: 1 year post-op). 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 6 May 2020.