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

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.

Study Overview

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

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • BeiJing JiShuiTan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients who were operated in our hospital because of distal humerus fractures in 2012-2017.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional result of elbow (objective)	Assess function of patients' affected elbow by MEPS (Mayo elbow performance score)	1 year post-op
Functional result of elbow (subjective)	Assess function of patients' affected elbow by and DASH (Disabilities of arm, shoulder and hand)	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.	1 year post-op

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complication: infection	Record patients' information about infection if any, including superficial and deep infection.	1 year post-op
Complication:stiffness	Record whether the patients had elbow stiffness (ROM<100° or arthrolysis having been performed)	1 year post-op
Complication: internal fixation irritation	Record whether there were internal fixation irritations	1 year post-op
Complication: failure of internal fixation	Record whether the patients have gone through internal fixation failure	1 year post-op
Complication: post-traumatic arthritis	Record if the patients have developed into post-traumatic arthritis, if any, record the degree.	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)	1 year post-op
severity of pain	Assess severity of pain by VAS (Visual analogue scale)	1 year post-op
nounion	Record if there is nonunion of the olecranon (evaluated by X-ray or CT scan)	1 year post-op

Collaborators and Investigators

• Sponsor: Beijing Jishuitan Hospital
• Investigators: Principal Investigator: Xieyuan Jiang, BeiJing JiShuiTan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2012
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): March 31, 2021

Study Registration Dates

• First Submitted: January 25, 2020
• First Submitted That Met QC Criteria: May 5, 2020
• First Posted (Actual): May 6, 2020

Study Record Updates

• Last Update Posted (Actual): May 6, 2020
• Last Update Submitted That Met QC Criteria: May 5, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Distal Humerus Fractures; Olecranon Osteotomy; Plate Fixation; Tension-band Fixation
• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Arm Injuries; Humeral Fractures
• Other Study ID Numbers: 201708-05

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No