Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00772850 |
| Other study ID # |
200804007R |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
October 14, 2008 |
| Last updated |
July 14, 2010 |
| Start date |
October 2008 |
| Est. completion date |
June 2010 |
Study information
| Verified date |
July 2010 |
| Source |
National Taiwan University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Taiwan: Department of Health |
| Study type |
Observational
|
Clinical Trial Summary
The purpose of this study is to investigate the potential insults of rotator cuff muscle and
the functional recovery of upper extremity function after antegrade nailing of humeral
fractures.
Description:
Background:
With improved implant design and surgical technique, operative treatment of humeral shaft
fractures increasingly has become accepted. Such treatment offers several advantages. The
rigidly fixed, fractured limb can be used early without external support, and the patient
can sleep, as normal, in the supine position. In addition, the angular deformity often seen
with conservative treatment effectively is prevented. Although plate osteosynthesis can
afford a rigid fixation and good functional recovery, its disadvantages have been reported.
By comparison, locked nailing, which provides sufficient fixation stability and prevents
slipout of the nail, offers the advantages of less soft tissue injury, a lower infection
rate, and no need for radial nerve extrication. Locked nailing is preferred especially for
open fractures, comminuted fractures, pathologic fractures, and fractures associated with
osteoporosis. The use of Seidel locked nails with spreading fins can be complicated by
inadequate fixation, intraoperative bone comminution, and unsatisfactory recovery of
shoulder function. Biomechanically, locked nails with transfixing locking screws allow much
better rotational control of the distal fragment than do Seidel nails. Most rigid humeral
nails are inserted antegrade, but a disadvantage to antegrade nailing has been the risk of
shoulder function impairment, which partially negates the advantages of closed nailing and
of loadsharing mechanical properties. The disadvantages of retrograde nailing are potential
risk of elbow joint injury and nonlinear entry portal of nailing.
Gaullier O et al did a study of 23 cases with rotator cuff evaluation in 1999. Only humeral
diaphyseal fractures were enrolled. Fracture type classification was according to AO.
Clinical shoulder assessment was carried out using the Constant score. Treatment was Seidel
intramedullary locked nailing.
Seidel intramedullary locked nailing was too big for patients in Taiwan. Compared to
patients in western countries, our patients had small stature. The humeral locked nail,
invented by Jinn Lin, provided a proper treatment option for humeral fractures in Asian
people.
Although H-L nail has the advantages of minimal tissue trauma, it still has the possibility
of rotator cuff injury. The purpose of our study is to evaluate rotator cuff injury in
antegrade humeral locked nailing for humeral fractures by means of sonographic evaluation
and shoulder functional examination.
Materials and methods:
I. Implant design:
The Humeral Locked nail is a uniform closed cylindrical tube with a 5° bend at 70 mm from
the threaded end. It is manufactured from 316L stainless steel (Carpenter Technology
Corporation, Indianapolis, IN) in 4 sizes: 7 (diameter) x 190 (length) mm, 7 x 210 mm, 8 x
210 mm, and 8 x 230 mm. The thickness of the nail wall is 1.5 mm for 8 mm nails and 1 mm for
7 mm nails. There are 3 parallel screw holes (the 2 outermost holes usually are used) at the
threaded end, 45° oblique to the axis of the nail, and 2 transverse screw holes at the other
end. Cortical screws are used as locking screws that are inserted under the guide of an L
shaped, nail mounted targeting device.
II. Patient selection:
The inclusion criteria for patients in the present study were listed as follows: (1)
subjects must sign and date informed consent; (2) subjects must be over fifteen years old,
of either sex; (3) subjects suffered from acute humeral fractures or non-unions; (4)
subjects were treated by antegrade H-L nailing (United, Taipei, Taiwan); 5) subjects had
solid union of fractures; 6) postoperative time was at least 12 months; 7) subjects were
operated between 2003 and 2006. The exclusion criteria for patients in the present study
were listed as follows: (1) subjects refusing to take the examinations, (2) subjects lost to
follow up, (3) subjected with pre-existing shoulder problems.
III. Study design:
Our study design is a retrospective, cross-sectional study. Patients with acute humeral
fractures or nonunions treated by antegrade H-L nailing were recruited and studied.
Sonographic evaluation of rotator cuff was done by an experienced orthopedist and shoulder
functional scores such as Neer score, Constant score and QuickDASH score was assessed at the
same time.
Real-time sonography was performed with a Sonoline Sienna scanner (HDI-5000, Philips, USA)
equipped with a 5.5-9.4-MHz linear-array transducer. The patient was seated on a stool with
the examiner sitting in front of him. Lateral transverse view and lateral longitudinal view
were acquired. For these two views, the arm of the examined patient was placed in adduction
and internal rotation, which gave a better exposure of the supraspinatus tendon under the
acromion. Criteria for full-thickness rotator cuff tears were nonvisualization of the
rotator cuff and hypoechoic or anechoic discontinuity. Besides, criteria for partial-
thickness rotator cuff tears included focal heterogenous hypoechogenecity and incomplete
hypoechoic cleft. Measurement of rotator cuff tears was done on lateral transverse and
longitudinal views. The width of rotator cuff tears was measured on lateral transverse view,
while the height of rotator cuff tears was measured on lateral transverse view. Moreover,
the length of rotator cuff tears was measured on lateral longitudinal view. The thickness of
rotator cuff at the dome of humeral head was measured on lateral transverse and compared
between the operative and sound sides. We calculate the ratio of the thickness of
supraspinatus on the operative side to that on the sound side.
a. Thickness rotator cuff tear:
Size (full or partial):
i. width (mm) ii. height (mm) iii. length (mm)
b. visualization of nail
c. scar: nature and size
d. supraspinatus thickness(mm) :
IV. Baseline variables and primary endpoints:
We included patient's age and gender, fracture location, fracture cause, presence of nail
removal, post-operative period and comorbidity or associated disease as independent
variables. Fracture location was either humeral neck or humeral shaft. Humeral neck
fractures were defined as fractures above surgical neck of the humerus. Humeral neck
fractures were further categorized into three groups: two-part, three-parts or four-parts,
according to Neer classification. Meanwhile, humeral shaft fractures were defined as
fractures below surgical neck of the humerus and 5 cm above the olecarnon fossa. Humeral
shaft fractures were separated into three groups: proximal third shaft fractures, middle
third shaft fractures and distal third shaft fractures. Fracture causes included simple
falls and traffic accidents. We calculate post-operative period according to the latest
operation involving rotator cuff injury, which included antegrade H-L nailing and nail
removal. For example, if patient X was treated by antegrade H-L nailing two years ago and
received nail removal one year ago, his (or her) post-operative period was twelve months
rather than twenty-four months.
The primary endpoints of the present study were functional scores and sonographic findings.
As to functional scores, we chose Neer score, Constant score and QuickDASH score as our
endpoints. Neer score consists of pain component, function component, range of motion
component and anatomy component. The interpretation of Neer score are listed as follows:
excellent when Neer score is above 89 units, satisfactory when Neer score is between 80 to
89 units, unsatisfactory when Neer score is between 70 to 79 units, failure when Neer score
is below 70 units. Constant score consist of pain, activity level, arm positioning, strength
of abduction and range of motion. We examined Constant score of affected and healthy
shoulder and calculated the difference of Constant scores between two shoulders. The
interpretation is according to the difference of Constant scores: excellent (0~5 points),
very good (6~10 points), good (11~20 points), fair (21~30 points) and poor (above 30
points). The QuickDASH outcome measure is a questionnaire which asks about a patient's
symptoms as well as his (or her) ability to perform certain activities. Patients should
answer this questionnaire based on their conditions in the last week.
V. Statistics:
We include age, gender, fracture location, fracture cause, the presence of nail removal,
post-operative period and comorbidity as independent variables. We use Neer score, Constant
score, QuickDASH score, the presence of full-thickness rotator cuff tear, partial-thickness
rotator cuff tear and scar , supraspinatus thickness ratio as dependent variables.
Univariate analyses were conducted with Student's t tests for continuous variables and Chi
square tests for binary variables. We also do multivariate regression analyses to adjust the
confounding factors. The difference is considered statistically significant when p value is
under 0.05.
VI. Sample size calculations (power analysis):
Neer score:
The primary endpoint is used for calculation of sample size. We assume that the standard
deviation of Neer score in our patients is 12 points. How many patients are required to have
a 80% power of detecting a 10-point difference in the mean of functional score between the
two groups at the 5% level of significance? The required sample size is 48 patients (24
patients for each group).
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