A Retrospective Study on the Outcome of Different Fixation Methods After Olecranon Osteotomy

• Conditions: Distal Humerus Fractures; Fixation Device; Complications; Osteotomy

• Registration Number: NCT04376801
• Lead Sponsor: Beijing Jishuitan Hospital

Brief 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. 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 Timeline

• Study Start: 2012-12-01
• Study First Submitted: 2020-01-25
• Status Verified: 2020-05
• Study First Submitted QC: 2020-05-05
• Last Update Submitted: 2020-05-05
• Study First Posted: 2020-05-06
• Last Update Posted: 2020-05-06
• Primary Completion: 2020-12-31
• Study Completion: 2021-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Patients over 18 years old;
2. Distal humerus fractures.

Exclusion Criteria

1. Pathological fractures;
2. Combined with fractures of ipsilateral upper limb;
3. Fracture over 2 weeks;
4. Patients who refused surgical treatment;
5. Patients who were unable to obtain the 1 year follow-up data after the operation.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Range of motion of elbow	1 year post-op	Measure and record the ROM of the affected elbow，including flexion, extension, pronation and supination degree.
Functional result of elbow (objective)	1 year post-op	Assess function of patients' affected elbow by MEPS (Mayo elbow performance score)
Functional result of elbow (subjective)	1 year post-op	Assess function of patients' affected elbow by and DASH (Disabilities of arm, shoulder and hand)

Secondary Outcome Measures

Name	Time	Method
Complication: infection	1 year post-op	Record patients' information about infection if any, including superficial and deep infection.
Complication: post-traumatic arthritis	1 year post-op	Record if the patients have developed into post-traumatic arthritis, if any, record the degree.
nounion	1 year post-op	Record if there is nonunion of the olecranon (evaluated by X-ray or CT scan)
Complication:stiffness	1 year post-op	Record whether the patients had elbow stiffness (ROM\<100° or arthrolysis having been performed)
Complication: failure of internal fixation	1 year post-op	Record whether the patients have gone through internal fixation failure
severity of pain	1 year post-op	Assess severity of pain by VAS (Visual analogue scale)
severity of ulnar nerve injury	1 year post-op	Assess and record severity of ulnar nerve injury (paralysis or weakness of intrinsic muscle of hand or parathesia of ring and little finger)
Complication: internal fixation irritation	1 year post-op	Record whether there were internal fixation irritations

Trial Locations

Locations (1)

Beijing Jishuitan Hospital; 🇨🇳 Beijing, China