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

NCT04376801 | Unknown

• 1 other identifier: 201708-05
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Distal Humerus Fractures; Osteotomy; Fixation Device; Complications

Keywords

Distal Humerus Fractures; Olecranon Osteotomy; Plate Fixation; Tension-band Fixation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

• Complication: infection

  1 year post-op

• Complication:stiffness

  1 year post-op

• Complication: internal fixation irritation

  1 year post-op

• Complication: failure of internal fixation

  1 year post-op

• Complication: post-traumatic arthritis

  1 year post-op

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patients over 18 years old;
• Distal humerus fractures.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Jishuitan Hospital: lead

Study Sites (1)

Beijing Jishuitan Hospital

Beijing, China

Location

MeSH Terms

Conditions

Humeral Fractures, Distal

Condition Hierarchy (Ancestors)

Elbow Fractures; Elbow Injuries; Arm Injuries; Wounds and Injuries; Humeral Fractures; Fractures, Bone

Study Officials

• Xieyuan Jiang

  Beijing Jishuitan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: January 25, 2020
• First Posted: May 6, 2020
• Study Start: December 1, 2012
• Primary Completion: December 31, 2020
• Study Completion: March 31, 2021
• Last Updated: May 6, 2020

Record last verified: 2020-05

Locations

CN (1)