Table 6.

Clinical evidence for ADMs in orthopaedic surgery.

Authors	Product name(s), Material	Usage, Population	Summary findings
(A) Achilles tendon repair
Case series and case reports
Bertasi et al. (2017)	DermACELL®, M-ADM	Achilles tendon repair 35-year-old fell and re-ruptured native tendon 2 months after repair with M-ADM. Histology specimens were obtained 1 month after re-rupture	Alcian Blue and PAS stains showed excellent attachment of paratenon to M-ADM without evidence inflammatory response Active infiltration of mesenchymal (likely synovial based on morphology) cells from paratenon into graft Neovascularisation in infiltrated areas with robust vascularisation at graft–paratenon interface 60% of graft depth vitalised with new cells
Retrospective studies
Cole et al. (2018)	ArthroFlex®, M-ADM	Achilles tendon repair 9 patients Mean age: 58.3 years Mean follow-up: 14.4 months	4/9 (44.4%) traumatic injuries, 5/9 (55.6%) ‘wear and tear’ Mean FFI-R at final follow-up: 33.0
(B) Foot/Ankle arthroplasty
Case series and case reports
Carpenter et al. (2017)	Arthroflex®	Interpositional ankle arthroplasty 4 patients (age range = 32–42 years)	Pain relief, ROM improvement in tibiotalar joint (from a mean of 16.5° preoperatively to 31° postoperatively. Mean preoperative AOFAS hind-foot ankle scores was 35 and increased to 88.5 postoperatively
Retrospective studies
Berlet et al. (2008)	??	Interpositional arthroplasty of first MTP joint 9 patients, 5 female Mean age: 53.3 years	Mean length of follow-up was 12.7 months; no complications or failures Mean AOFAS score and pain sub-score increased from 63.9 and 17.8 preoperatively to 87.9 and 34.4 postoperatively
(C) Foot/Ankle
Prospective studies
Pontell et al. (2018)	ADM, Integra™; Ethicon Inc	RSAFs 8 patients, 4 with an immediate STSG and 4 with a delayed STSG	Patients with the immediate STSG had a mean time to heal of 141.2 days, with 2 patients needing another operation Patients with the delayed STSG had a mean time to heal of 104.5 days, with 1 patient needing another operation
(D) Rotator cuff repair
Case studies and case series
Neumann et al. (2017)	Porcine dermal matrix xenograft	60 patients (61 shoulders) were observed for an average of 50.3 months	Average VAS pain score decreased from 4 to 1 postoperatively Average active forward flexion, external rotation at 0°, internal rotation at 0°, supraspinatus strength, infraspinatus strength all increased postoperatively MASES score was 87.8 on average postoperatively Postoperative ultrasound showed 91.8% of repairs were intact
Mirzayan et al. (2019)		25 shoulders (during 2006–2016) with massive rotator cuff tears underwent a procedure with an ADM Mean patient age: 61 years	Significant improvements in VAS and ASES scores for type I and II grafts No difference between VAS and ASES scores postoperatively in type I and II grafts No improvements in VAS and ASES for type III grafts
Retrospective studies
Hohn et al. (2018)	??	From 2008 to 2014, 23 patients who received a revision RC repair augmented with ADM with >2 years of follow-up Mean age: 60.1 years	Improved ASES and SANE scores postoperatively
(E) Glenoid resurfacing
Case study and case series
Namdari et al. (2013)	Graftjacket®	2 patients who had hemi-arthroplasty and biologic glenoid resurfacing	Both patients had a foreign body reaction that necessitated a revision surgery
(F) Forearm/Hand/Wrist
Laboratory study
Ehsan et al. (2012)	Arthroflex, LifeNet Health	Scaphoid and lunate with the scapholunate ligament were taken from 15 cadaveric specimens 5 specimens were kept intact, 5 were reconstructed with a 1.0-mm-thick dermal matrix, and 5 were reconstructed with a 1.5-mm-thick dermal matrix	The intact specimens failed at an average of 172 N and failed mid-scapholunate ligament The specimens with 1.0-mm dermal matrix failed at an average of 77 N and failed at the suture–matrix interface The specimens with 1.5-mm dermal matrix failed at an average of 111 N and failed at the bone–suture anchor interface
Case study and case series
Gould et al. (2019)		2 female patients treated to prevent recurrence of distal radioulnar heterotopic ossification	Improvements in ROM, supination and pronation postoperatively No postoperative complications or recurrence of heterotopic ossification
Peterson and Adham (2006)	ADM (AlloDerm)	5 patients with postoperative and 5 patients with post-traumatic neuropathic pain at the wrist had a neuroma excision and/or neurolysis with interposition of an ADM between skin and nerve	Patients were followed for 12–25 months and had improvements in pain 8 patients returned to work
Retrospective studies
Terry et al. (2014)	Alloderm; LifeCell, Bridgewater, NJ, USA	43 patients who had open fasciotomies between 2005 and 2012. 23 treated with ADM Median age: 66.5 years	Recurrence was seen in 1 of 23 patients with ADM and 5 of 20 patients without (P = 0.045)
Prospective studies
Hoang et al. (2019)	ADM (FlexHD)	132 patients having an open fasciotomy for Dupuytren’s disease. 28 patients were treated with the ADM Median age: 67 years	In the ADM group, the mean preoperative interphalangeal joint flexion contracture was 66.5° ± 29.9° and was corrected to 9.7° ± 12.4° In the control group, the mean preoperative interphalangeal joint flexion contracture was 51.4° ± 23.9° and was corrected to 7.8° ± 4.1° (P < 0.05) At follow-up, there was recurrence in 1/28 patients in the ADM group and 9/104 in the control group
Kokkalis et al. (2009)	GraftJacket (ADM)	100 thumbs with trapeziometacarpal osteoarthritis had surgery with ADM instead of the flexor carpi radialis tendon autograft	All but one patient had significant improvement in pain scale rating, grip and pinch strength No foreign body reactions or infections
(G) Hip
Prospective studies
Rao et al. (2016)	Graft Jacket; Wright Medical Technology, Arlington, TN, USA	12 patients who had a transosseous repair of the gluteus medius and minimus insertions augmented with ADM	Significant improvements in pain (VAS), limp, gait and abductor strength Trendelenberg test became negative in 11 patients At an average follow-up of 22 months, Harris Hip Scores improved from 34.05 to 81.26 (P < 0.001)

ADM, acellular dermal matrix; AOFAS, Association of Orthopaedic Foot and Ankle Society; ASES, American Shoulder and Elbow Surgeons; FFI-R, Foot Function Index-Revised; M-ADM, human dermis processed with Matracell®; MTP, metatarsophalangeal; PADM, porcine acellular dermal matrix; PAS, Periodic acid–Schiff; ROM, range of motion; RSAF, reverse sural adipofascial flap; STSG, split-thickness skin graft; VAS, Visual Analogue Scale.