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

Osteotomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04376801
• Other study ID #: 201708-05
• Status: Enrolling by invitation
• Start date: December 1, 2012
• Est. completion date: March 31, 2021

Study information

• Verified date: May 2020
• Source: Beijing Jishuitan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: March 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Distal Humerus Fractures
• Fixation Device; Complications
• Humeral Fractures
• Osteotomy

Locations

Country	Name	City	State
China	Beijing Jishuitan Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Jishuitan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional result of elbow (objective)	Assess function of patients' affected elbow by MEPS (Mayo elbow performance score)	1 year post-op
Primary	Functional result of elbow (subjective)	Assess function of patients' affected elbow by and DASH (Disabilities of arm, shoulder and hand)	1 year post-op
Primary	Range of motion of elbow	Measure and record the ROM of the affected elbow,including flexion, extension, pronation and supination degree.	1 year post-op
Secondary	Complication: infection	Record patients' information about infection if any, including superficial and deep infection.	1 year post-op
Secondary	Complication:stiffness	Record whether the patients had elbow stiffness (ROM<100° or arthrolysis having been performed)	1 year post-op
Secondary	Complication: internal fixation irritation	Record whether there were internal fixation irritations	1 year post-op
Secondary	Complication: failure of internal fixation	Record whether the patients have gone through internal fixation failure	1 year post-op
Secondary	Complication: post-traumatic arthritis	Record if the patients have developed into post-traumatic arthritis, if any, record the degree.	1 year post-op
Secondary	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)	1 year post-op
Secondary	severity of pain	Assess severity of pain by VAS (Visual analogue scale)	1 year post-op
Secondary	nounion	Record if there is nonunion of the olecranon (evaluated by X-ray or CT scan)	1 year post-op