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Buncke. Plast Aesthet Res 2022;9:38 https://dx.doi.org/10.20517/2347-9264.2022.08 Page 9 of 17
Table 3. Clinical studies using off-the-shelf commercially available engineered nerve allografts reporting outcomes
Implants
Mean gap Nerve type, Mean follow-
Author, year Study type used/n- Outcomes
length n-value up
value
Karabekmez et Retrospective 22.3 mm Sensory, n = 9 months Allograft, n = The average static two-point discrimination was 5.5 mm, and the moving two-point discrimination was 4.4
[61]
al. , 2009 (Range 5-30 10 10 mm. This was the first study to show clinical efficacy for using clinically available engineered nerve grafts to
mm) treat sensory defects up to 3 cm in length
[62]
Brooks et al. , Retrospective 22 11 mm Sensory, n = 264 152 days Allograft, n = A meaningful recovery in 87.3% of repairs for motor (> M3) and sensory (> S3) function on MRCC scale.
2012 observational (Range 5-50 49 76 Provides functional recovery in sensory, mixed and motor nerve injuries in gaps up to 50 mm
mm) Mixed, n = 18
Motor, n = 9
[63]
Cho et al. , Retrospective 23 12 mm Sensory, n = 296 160 days Allograft, n = Meaningful recovery (≥ S3 and ≥ M3)
2012 observational (Range 5-50 35 51 was achieved in 86% of cases
mm) Mixed, n = 13
Motor, n = 3
[47]
Ducic et al. , Retrospective Primary, 0 Unknown Primary 204.0 Primary, n = 8 The recorded average QuickDASH (disabilities of the arm, shoulder, and hand) questionnaire was reported to
2012 observational mm 41.3 weeks Conduit, n = 27 average 23.2 19.8. There were no significant differences between repair type with respect to outcomes
Conduit, 9.1 Conduit 186.4 Autograft, n =
3.7 mm 56.7 weeks 11
Autograft, Autograft Allograft, n = 8
37.5 13.2 mm 250.5 59.3
Allograft, 17.6 weeks
7.5 mm Allograft 129.7
89.2 weeks
[64]
Guo et al. , Retrospective 23 mm Digital, n = 5 13 mon. Allograft, n = 5 All patients reported sensory improvement during the follow-up period after operation. Mean Static two-point
2013 observational (Range 18-28 (Range 12-15 discrimination of 6 mm was recorded, and the range of the Semmes-Weinstein Monofilament test was 4.31 to
mm) months) 4.56
[65] [66]
Taras et al. , Prospective 11 mm Digital, n = 18 15 mon. Allograft, n = According to custom Taras scale, excellent results in 39% of repairs, good results in 44% of repairs, fair
2013 (Range 5-30 (Range 12-20 18 results in 17% of repairs and poor results in no repairs
mm) months)
Isaacs and Retrospective 33 10 mm Sensory, n = 2 13 months Allograft, n =15 Meaningful recovery for motor (≥ M3) function in 85% of repairs and sensory (≥ S3) function in 67% of
[67]
Safa , 2017 observational (Range 5-50 Mixed, n = 13 repairs, independent of nerve diameter
mm)
[68]
Rinker et al. , Retrospective 35 8 mm Sensory, n = 11 months Allograft, n = Meaningful recovery for sensory (≥ S3) function in 86% of repairs
2017 observational (Range 25-50 50 50
mm)
[69]
Zhu et al. , Retrospective 27 ± 13 mm Sensory, n = 355 158 days Allograft, n = Meaningful recovery for motor (≥ M3) function in 66.7% of repairs and sensory (≥ S3) function in 84.6% of
2017 observational 39 64 repairs
Mixed, n = 19
Motor, n = 6
Carlson et al. Retrospective 65 45 mm Sensory, n = 15 5 months Allograft, n = Meaningful recovery for motor (≥ M3) function in 33.3% of repairs and sensory (≥ S3) in 91.7% of repairs
[70]
, 2018 observational (Range 10- 11 19
140 mm) Mixed, n = 3
Motor, n = 2