Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02784522 |
| Other study ID # |
QinghaiUH_001 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
May 19, 2016 |
| Last updated |
May 24, 2016 |
| Start date |
May 2014 |
| Est. completion date |
December 2015 |
Study information
| Verified date |
May 2016 |
| Source |
Qinghai University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
China: Ministry of Health |
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Treatment for proximal humerus fractures emphasizes the restoration of shoulder function.
Older patients, because of the loss of bodily functions, face enormous difficulties in
fracture healing and shoulder functional recovery after sustaining proximal humerus
fractures. As previously reported, open reduction with conventional locking plate fixation
achieved fair outcomes in 48 cases of proximal humerus fractures in older patients, with an
excellent rate of 85.4% according to the Neer classification system. The investigators'
clinical experience, however, has shown that the stability of internal fixation is
inadequate and must be enhanced. Consequently, the investigators design a microsurgical
implantation using a locking compression plate (LCP) to treat proximal humerus fractures in
older patients.
In a search of the Web of Science database, the investigators found a randomized controlled
trial reported by Wang et al. in which LCP fixation using microsurgical techniques had
better outcomes in 20 cases of proximal humerus fractures in older patients. However, the
limitation created by the small sample size had profound effects on the reliability of their
study.
No relevant articles were retrieved from the Chinese Clinical Trial Register, and only one
similar article was found on ClinicalTrials.gov: "Proximal Humerus Fractures: Randomized
Study Between Locking Nails and Locking Plates for Neer 2 and 3 Parts" (identifier:
NCT01984112). In this clinical trial, Constant-Murley scores were considered the primary
outcome, and the follow-up period was 12 months. Importantly, the inclusion criteria and
study arms were distinctly different from those in the investigators' study protocol.
The main principle of minimally invasive techniques in orthopedics is to implant a specific
bony plate, which is fixed across a transverse fracture, via small incisions of the
periosteum, skin, and muscle. These implantation devices include less invasive stabilization
systems, dynamic compression plate systems, and LCP systems. Internal fixation with the LCP
system involves two completely different fixation techniques and two opposing osteosynthesis
principles, namely conventional plate and bridging plate osteosyntheses characterized by
direct anatomical reduction. Because of its special design, the LCP can be used as a dynamic
compression plate, as a pure internal fixator using locking head screws, or as both
combined, thus providing a variety of therapeutic options for surgeons. Moreover, the LCP
has good stability and induces less damage to the periosteum; it is therefore beneficial for
bone healing and functional recovery. Given these characteristics, the LCP is likely to have
stronger stability than the conventional locking plate for internal fixation of fractures.
Therefore, the investigators design a study protocol that compares the LCP and conventional
locking plate using minimally invasive techniques for internal fixation of proximal humerus
fractures in older patients. The investigators hypothesize that the LCP will be more
effective than the conventional locking plate in promoting shoulder function recovery with a
higher excellent rate according to the Neer classification system for proximal humerus
fractures.
Data collection, management, analysis, and open access
- Data collection: All data, including demographic information, disease diagnosis,
concomitant diseases, allergic history (drug allergy), and adverse reactions, will be
collected on a case report form and summarized in one form. These data will be recorded
electronically using a double-data entry strategy by EpiData software.
- Data management: Only the project manager will have the right to query the database,
and changes will not be allowed. All data relevant to this clinical trial will be
preserved by the Affiliated Hospital of Qinghai University.
- Data analysis: All data will be statistically analyzed by professional statisticians.
The statistical report by the statisticians will be given to the project manager
responsible for writing the research report. An independent data monitoring committee
will be in charge of data monitoring and management throughout the entire trial to
ensure scientific accuracy, authenticity, and integrity.
- Open data: Published data will be released at www.figshare.com.
Statistical analysis The statistical analysis will be completed by statisticians using the
SPSS 19.0 statistical software (IBM Corp., Armonk, NY, USA) in line with the
intention-to-treat principle. Intergroup comparison for the excellent rate according to the
Neer classification system will be performed using the chi-square test. The operation time,
intraoperative blood loss, postoperative hospital stay, fracture healing time, visual
analogue scale scores, and SF-36 scores will be compared using the Mann-Whitney U test. A
value of P < 0.05 will be considered statistically significant.
Adverse events
- Predicted and unanticipated adverse events will be recorded during the trial.
- Adverse events including dizziness, fever, infection, subacromial impingement, humeral
head necrosis, malunion, and severe pain will be detected.
- All serious adverse events will be recorded in detail, including the date of
occurrence, type of event, and treatments, all of which will be reported to the project
manager and institution review board within 24 hours.
