Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02951468 |
| Other study ID # |
Beiromat_04 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
October 23, 2016 |
| Last updated |
November 3, 2016 |
| Start date |
January 2010 |
| Est. completion date |
February 2016 |
Study information
| Verified date |
October 2016 |
| Source |
Technische Universität München |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Germany: Medizinische Fakultät, Klinikum rechts der Isar, Technische Universität München |
| Study type |
Observational
|
Clinical Trial Summary
Background Treatment of clavicular non- and malunion is still challenging. Current surgical
procedures often result in partially frustrating functional outcome along with high-grade
subjective impairment and increased rates of revision surgery. However, the combination of
vital bone graft and a biomechanically sufficient fixation system seems to be a promising
concept of treatment.
Methods In this retrospective study, 14 patients with a mean age of 44 years (26-67 years)
suffering from non-union (n=11) and/or malunion (n=4) of the clavicle were enrolled. All
patients were surgically treated using an anatomical precontoured locking compression plate
(LCP) and autologous iliac crest bone graft. Functional outcome was assessed using the age-
and sex-specific relative Constant Score.
Description:
Methods
Patients and follow-up
All patients who were treated for clavicular non- or malunion with a locking compression
plate and an iliac crest bone graft between January 2010 and December 2014 were included in
this retrospective study. The study protocol was approved by the local ethics committee
(71/15 S).
The preoperative symptoms included pain (n=12), limited range of motion (n=2), pain when
sleeping on the affected side (n=2), skin irritation caused by dislocated screws (n=1),
feeling of weakness of the arm (n=1) and crepitation (n=1).
Standard radiographs of the affected clavicle (anterior-posterior path of rays perpendicular
to radiographic cassette, anterior-posterior path of rays 30° tilted cephalad) were
performed at the time of the initial presentation of the patient as well as during the
routine follow-up examinations in our outpatient clinic. Preoperative planning included the
performance of a magnetic resonance imaging (MRI) scan to estimate the non-vital parts of
bone to be resected as well as the performance of a computed tomography (CT) scan of both
clavicles to measure the original clavicle length to be able to adequately decide if a bone
graft would be required. A tricortical iliac crest bone graft was used in all cases with
bony defects larger than 15 mm due to the risk of abnormal shoulder biomechanics following
clavicular shortening possibly resulting in pain, shoulder motion impairment and loss of
strength.
The Constant Score was used to assess the shoulder function and activity preoperatively as
well as during the routine follow-up examinations in our outpatient clinic. Subsequently the
original Constant Score values were converted according to Gerber et al. to receive a
normative age- and sex-specific Constant Score (relative Constant Score).
The implant
The LCP (locking compression plate) superior anterior clavicle plate with lateral extension
(Depuy) is an anatomically precontoured fixation system with three to eight medial shaft
holes for 3.5 mm locking or 3.5 mm cortex screws and six lateral 2.7 mm divergent locking or
2.4 mm cortex screws. This implant was used for treatment of all enrolled patients.
Surgical technique and rehabilitation
All patients underwent surgery placed in a beachchair position with the affected arm in a
mobile position. A longitudinal skin incision was set below the clavicle with subsequent
incision through the clavi-pectoral fascia also in longitudinal direction to allow for a
later closure to ensure sufficient soft tissue coverage. After exposure of the non- or
malunion a complex multidimensional osteotomy of the clavicle with medial and lateral axial
correction up to vital bone was performed. Vital bone was verified by local blood
extravasation resulting from drilling the previously osteotomized bone segments. The
tricortical iliac crest bone graft was harvested according to the size assessed in the
preoperative CT scan, consecutively adapted to the intraoperative measured size of the bony
defect. After implantation of the bone graft the LCP was centered onto the clavicular shaft.
At least three screws should be placed medially and laterally to the bone graft to ensure
sufficient biomechanical stability. Before drilling the screw holes the plate position was
controlled by fluoroscopy. If necessary the iliac crest bone graft should additionally be
fixed by a suture cerclage (Fiber- Wire, Arthrex). After a final radiographical examination
the wound was closed layer by layer.
Regarding postoperative rehabilitation primarily the affected arm was immobilized in a sling
for 6 weeks. Patients started physiotherapy on the first postoperative day following a
standard rehabilitation protocol: abduction and flexion were restricted to 30° for the first
two weeks, to 60° for the week three and four postoperative and to 90° for week five and six
postoperative. Full weight bearing was not allowed before week 12 postoperative. 3, 6, 12
and 24 weeks postoperatively radiographs were performed to evaluate bone healing.
