Foot & Ankle International - September 2020 - 1035

Chrea et al	

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Table 1.  Comparison of PROMIS Scores Between PVACM (n = 60) and CM (n = 73) Patients.a

Physical Function
PVACM
CM
P value
Pain Interference
PVACM
CM
P value
Pain Intensity
PVACM
CM
P value
Global Physical Health
PVACM
CM
P value
Global Mental Health
PVACM
CM
P value
Depression
PVACM
CM
P value

Preoperative score (± SD)

Postoperative scoreb (± SD)

P value

Score change (± SD)

44.6 (± 8.2)
45.0 (± 6.3)
.763

48.8 (± 8.0)
51.8 (± 8.7)
.043

<.01
<.01

+3.6 (± 6.2)
+7.1 (± 8.5)
.011

58.9 (± 6.5)
58.1 (± 5.7)
.466

51.2 (± 8.4)
49.4 (± 9.6)
.248

<.01
<.01

-7.2 (± 8.6)
-9.1 (± 9.2)
.268

51.6 (± 6.1)
49.9 (± 6.7)
.139

43.4 (± 8.7)
39.9 (± 8.3)
.019

<.01
<.01

-7.5 (± 7.7)
-10.2 (± 8.6)
.086

46.9 (± 7.5)
47.3 (± 7.4)
.765

51.9 (± 8.7)
53.8 (± 8.2)
.216

<.01
<.01

+5.1 (± 7.2)
+6.7 (± 7.2)
.229

53.1 (± 8.1)
54.1 (± 8.9)
.507

54.0 (± 8.8)
55.5 (± 8.8)
.352

.245
.074

+1.1 (± 5.3)
+1.0 (± 6.9)
.948

46.9 (± 7.7)
47.4 (± 8.5)
.750

47.6 (± 6.4)
46.9 (± 8.3)
.606

.509
.611

+0.4 (± 5.9)
-1.9 (± 10.0)
.148

Abbreviations: CM, cheilectomy and Moberg without PVA implant; PROMIS, Patient-Reported Outcomes Measurement Information System; PVA,
polyvinyl alcohol; PVACM, cheilectomy and Moberg with PVA implant.
a
Boldface type indicates statistical significance.
b
Postoperative scores represent the latest available survey follow-up scores. The average time to survey follow-up was 14.5 (range, 12-25) months for
PVACM patients and 15.6 (range, 12-25) months for CM patients.

Results
Clinical Outcomes
Both the PVACM and CM cohorts demonstrated significant improvement in Physical Function, Pain Interference,
Pain Intensity, and Global Physical Health (P < .01)
(Table 1). Preoperatively, there were no significant differences in PROMIS domains between the PVACM and CM
cohorts. Postoperatively, the CM group demonstrated
significantly greater Physical Function (51.8 ± 8.7 vs
48.8 ± 8.0; P = .043) with a significantly greater improvement pre- to postoperatively (7.1 ± 8.5 vs 3.6 ± 6.2; P =
.011) compared with the PVACM group. In addition, the
CM group demonstrated significantly lower Pain Intensity
(39.9 ± 8.3 vs 43.4 ± 8.7; P = .019) compared with the
PVACM group (Figure 3).
A total of 7 PVACM (11.7%) and 8 CM (11.0%) patients
reported persistent pain postoperatively. These patients
were subsequently treated with a combination of steroid
injections, orthotics, and/or shockwave therapy. The rates
of persistent pain requiring additional intervention were not
significantly different between groups (P = .90).

Three PVACM patients (5%) had a documented postoperative infection requiring antibiotics. No patient who
underwent CM had a documented postoperative infection
(P = .05). No other major postoperative events were
reported in either group. There were no significant differences in complication rates across the surgeons represented.

Revisions
The rate of revision between the PVACM and CM groups
was not significantly different (P = .21). Three out of 60
PVACM patients (5%) required revision surgeries at 14, 22,
and 33 months, respectively, following the index surgery.
One revision included a patient who developed inflammation and fibrous tissue at the MTP joint with loosening of
the PVA implant 14 months postoperatively; this patient
underwent removal of the PVA implant with conversion to
MTP arthrodesis and bone grafting. A second patient presented with first MTP pain and was noted to have wearing
of the medial aspect of the implant; this patient underwent
removal of the implant and revision hemiarthroplasty at
22 months postoperatively. A third patient presented with
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