Minimally Invasive of Proximal Humerus Fractures With Internal Fixation Improves Shoulder Function in Older Patients

NCT02784522 | Completed

• 1 other identifier: QinghaiUH_001
• Study Type: interventional
• Target: 82
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study protocol represents an attempt to objectively choose appropriate methods for internal fixation of proximal humerus fractures in older patients by comparing locking compression plate with conventional steel plate fixation to improve shoulder function.

Conditions

Humerus Fractures

Outcome Measures

Primary Outcomes (1)

• Neer classification system score

  Clinical outcome scores according to the Neer classification system will be used to assess shoulder function recovery.

  month 6 after surgery

Secondary Outcomes (3)

• change of visual analogue scale score

  day 1, day 3 and week 1, week 2 after surgery

• change of X-ray examinations

  month 0.5, month 1, month 3, and month 6 after surgery

• Change of Medical Outcomes Study 36-item Short Form Health Survey (SF-36) Score

  month 0.5, month 1, month 3, and month 6 after surgery

Study Arms (2)

locking compression plate group

EXPERIMENTAL

In the experimental group, patients will undergo closed reduction via a lateral approach to the shoulder followed by locking compression plate fixation using a minimally invasive technique.The locking compression plate is purchased from Xiamen Dabo Yingjing Medical Devices Co., Ltd., Xiamen, China.

Device: locking compression plate group

conventional locking plate group

ACTIVE COMPARATOR

Patients in the control group will be subjected to closed reduction via a lateral approach to the shoulder followed by conventional steel plate fixation using a minimally invasive technique. The conventional locking plate is purchased from Xiamen Dabo Yingjing Medical Devices Co., Ltd., Xiamen, China.

Device: conventional locking plate group

Interventions

locking compression plate group DEVICE

Closed reduction via shoulder lateral approach followed by locking compression plate fixation using minimally invasive technique

locking compression plate group

conventional locking plate group DEVICE

Closed reduction via shoulder lateral approach followed by conventional locking plate fixation using minimally invasive technique

conventional locking plate group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Neer II or III fractures as shown by X-ray examination
• Presentation with soft tissue swelling of the shoulder, limited mobility, tenderness, unusual activity, or a palpable sense of bone rubbing
• Unilateral traumatic fracture
• Over 60 years of age
• Admission to the hospital within 6 hours after injury
• Informed consent from patients or their relatives

You may not qualify if:

• Concomitant injuries involving pathological fracture, blood vessel injury, or nerve injury
• Head-split humerus fractures
• Severe comminuted proximal humerus fractures involving \> 40% of the articular surface of the humeral head
• Disturbance of consciousness, cerebral infarction, cancer, severe medical complications (such as heart, lung, or kidney failure; severe hypertension; diabetes; or blood diseases)
• History of shoulder or elbow dysfunction

Sponsors & Collaborators

• Qinghai University: lead

Related Publications (1)

• Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6(6):CD000434. doi: 10.1002/14651858.CD000434.pub5.

  PMID: 35727196 DERIVED

MeSH Terms

Conditions

Humeral Fractures

Condition Hierarchy (Ancestors)

Arm Injuries; Wounds and Injuries; Fractures, Bone

Study Officials

• Tao Wu, Master

  Affiliated Hospital of Qinghai University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: May 19, 2016
• First Posted: May 27, 2016
• Study Start: May 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: December 1, 2015
• Last Updated: May 27, 2016

Record last verified: 2016-05