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HSS Research Institute

Early Mobilization following Adult Acquired Flatfoot Deformity Reconstruction

IRB Number: 28019
(inactive trial)

Institutional Review Board, Hospital for Special Surgery

August 27, 2008

The safety of study participants is our top priority. The trial is approved and periodically reviewed by an Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.

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Principal Investigator

Jonathan T. Deland, MD


Scott Ellis, M.D.
Elizabeth Young, B.S.


In this pilot study, we will identify 36 patients with Posterior Tibial Tendon Insufficiency who will be undergoing a flatfoot reconstruction. These patients will be informed of an early mobilization time following the operation (shorter time spent in the cast and nonweightbearing) and randomly assigned to either the early mobilization group or normal group. The primary outcome will of this study will be pain, as determined by the patient on a continuous scale (Visual Analog Scale) from 1 to 10. Preoperatively and at 10 weeks, 4 months, 6 months, 12 months, and 24 months postoperatively, 3 surveys (AOFAS, SF36, and Level of Activity) and a diagram of the foot (medial, lateral, plantar, dorsal of both feet) will be distributed for completion by the participant. These will be analyzed for mean and s.d. using the student t-test. Furthermore, radiographs will be taken preoperatively, and at 2 weeks, 6 weeks, 10 weeks, 4 months, 6 months, 12 moths, and 24 months as is already done routinely. Standard AP and lateral foot x-ray measurements will be done and recorded at each time point and analyzed for mean and s.d. using the student t-test. Also at 10 weeks, a CT scan will be taken to assess bony healing. Significant radiographic angular differences between these groups will be noted at each time point. Finally, for both groups, the following outcomes will be measured (with values bolded and italicized).

a. X-rays: presence or absence of bridging callous (all X-rays and CT scans will be read in blind fashion by an independent radiologist)
b. CT scan: at 10 weeks looking for presence or absence of bridging callous
c. Tenderness: none, mild, moderate
d. Union: Delayed Union or Nonunion:                    

                                   MCO            LCL                 TMT fusion
     Delayed union        > 6 weeks      > 10 weeks     > 12 weeks 
     Nonunion               > 6 months     > 6 months      > 6 months

2. FAOS (all subcomponents)
3. SF-36 (all subcomponents)
4. Time back to work (what is job)
5. Complications (presence or absence):
a. Superficial infection: infection only in superficial wound that does not penetrate below superficial facial layer
b. Deep infection: infection penetrates below superficial facia down to ligament, tendon, or bone
6. Re-operation: for any reason
7. Delayed union (as above)
8. Nonunion (as above)
9. Nerve damage: loss of sensation, motor strength, or persistent neuropathic pain

Inclusion/Exclusion Criteria

We are seeking to enroll 36 males or females, between the ages of 18 and 65, with severe adult acquired flatfoot who will be having surgery to correct the flatfoot. These will be existing patients of the Principle Investigator and inclusion (prior to consent) will be determined upon clinical examination.

The following exclusion criteria will be used: any history of foot trauma or surgery, recurrent foot pain and/or foot symptoms other than those associated with the adult acquired flatfoot and posterior tibial tendon insufficiency. Furthermore, pregnant women, diabetics, heavy smokers, and those who use any kind of steroids will be excluded (as these were found to adversely affect wound healing3, 4, 6, 9, 11).

Contact Information

Elizabeth Young