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EnFix Biological Scaffold

Overview

Rotator cuff repair is a high-volume procedure, with approximately 500,000 surgeries performed annually in the USA [1]. Despite this volume, failure rates vary significantly based on tear size and patient factors, ranging from 20% to 94% [1]. Specifically, re-tear rates are reported as 22 +/- 7% for small-to-medium tears (1-3 cm), 46 +/- 21% for large tears (3-5 cm), and 58 +/- 12% for massive tears involving two or more tendons [1]. Longo et al. meta-analysis further confirms radiographic re-tear rates of 15-21% across time points from 3 months to beyond 24 months [1]. The economic impact is substantial, with the cost of failed rotator cuff surgery in the USA estimated at over $430 million in 2022 [1].

The persistent clinical problem of lack of healing at the tendon-bone interface is termed "enthesis failure syndrome" [3]. Most existing augmentation products function as overlay (onlay) patches that reinforce the tendon, whereas EnFix implants (Tetrous Inc.) target healing at the enthesis where failure actually occurs [3]. EnFix represents the first-to-market, procedure-specific implant utilizing patented Demineralized Bone Fiber (DBF) technology [1]. DBF is a next-generation form of demineralized bone matrix (DBM) that employs proprietary water-assisted injection molding (WAIM) and FormLok processes to yield shaped, osteoinductive allograft implants [1]. The concept is termed "inlay" augmentation, placing the scaffold between bone and tendon at the footprint rather than on top of the tendon [8][9].

EnFix products are 100% cortical bone allogenic tissue products with no additives or excipients, conforming to FDA HCT/P regulations under 21 CFR Part 1271 and Section 361 of the PHS Act [1]. This approach is underpinned by the foundational biology established by Marshall Urist's 1965 discovery of bone morphogenetic proteins (BMPs) from demineralized bone matrix [1]. Commercially, EnFix was launched in a controlled fashion in July 2023 with 7 surgeons; as of May 2025, 35 surgeons have completed over 700 cases with over 1,500 implants deployed [1]. A multi-center prospective clinical study with 6 surgeons at 6 centers (Australia, New Zealand, USA) was initiated in May 2025 [1].

Anatomy & Pathophysiology

Enthesis Structure and Function

The native tendon-bone interface (enthesis) features a fibrocartilage transitional region with gradations in cell phenotype, matrix composition, tissue organization, and mechanical properties [1][2]. This four-zone structure—comprising bone, mineralized fibrocartilage, unmineralized fibrocartilage, and tendon—facilitates effective load transfer between materials of differing stiffness by reducing stress concentrations at the interface [1][2].

Healing Limitations and Failure Patterns

The enthesis has poor healing potential; after repair, biomechanically inferior fibrovascular scar tissue typically forms rather than native fibrocartilaginous tissue [1][2][8]. Incomplete healing and gap formation commonly occur at the enthesis, increasing re-tear risk; most failures occur within the initial 6-26 weeks after arthroscopic repair (mean 19.2 weeks) [2]. Healing of rotator cuff tendon repair is dependent on bone ingrowth into the repaired tendon; a fibrovascular interface tissue forms first, followed by gradual bone ingrowth and eventual re-establishment of collagen fiber continuity [4]. In a sheep model, a gap consistently formed between the end of the repaired tendon and bone, with reparative scar tissue and new bone spanning the gap [4].

Biological Scaffold Mechanisms

DBM/DBF promotes healing through both osteoconductive (providing a scaffold for cell migration and attachment) and osteoinductive (containing BMPs that stimulate mesenchymal stem cell differentiation into osteoblasts and chondrocytes) properties [2]. DBM contains growth factors including BMP-2 through BMP-7, transforming growth factor-beta, fibroblast growth factor, and platelet-derived growth factor [1][4][7]. The osteoinductive capacity of DBM triggers endochondral ossification, recapitulating embryonic development of bone-to-tendon attachment [1][2].

EnFix Design and Clinical Context

Tetrous' patented process demineralizes bone first, then cleaves fibers along the bone's long axis, preserving the natural nanotopography of collagen fibrils that conventional acid-treated DBM processing destroys [1][3]. EnFix implants have a porosity of 39% with average pore size of 160 microns, enabling cellular transport; competitor electrospun products have pore sizes less than 10 microns, too small for cellular transport [1]. The cannulated design of EnFix allows blood and bone marrow elements from subchondral bone to flow up into the healing site, providing a "crimson duvet" effect via the DBF fibers [1]. Bone marrow aspirate and microfracture techniques (the original "crimson duvet" described by Snyder) have failed to show benefit in randomized studies: Hong et al. showed no benefit for bone marrow stimulation, and Cole et al. showed bone marrow aspirate concentrate failed to improve outcomes [1]. A 2017 NIH/NIAMS roundtable on Innovative Treatments for Enthesis Repair highlighted enthesis repair as a critical unmet need [1].

Classification

EnFix Product Types

EnFix RC: Designed for use with suture anchors (sizes 4.5mm-6.5mm). The device features a "top hat" shape with an 8.5mm diameter top and a 13mm long peg portion. It is inserted into the awl hole used for suture anchor insertion and held in place by the anchor [1][3]. - TET-RC-45: For use with suture anchors 4.5mm to 5.5mm [3]. - TET-RC-55: For use with suture anchors larger than 5.5mm [3].

EnFix TAC-O: Features an 8.5mm round top. It is placed between medial and lateral anchor rows in a double-row repair or independently of anchors. The device is compatible with all-suture anchors [1][3].

EnFix TAC-T: Features a 10mm x 4mm rectangular top. It is placed between anchor rows. This design allows surgeon choice of format based on tear size and anatomy [1][3].

Inlay vs Onlay Augmentation

Onlay scaffolds: Placed on top of the tendon. They do not address the bone-tendon interface, have shown mixed clinical results, and fail to recreate the native enthesis [1][8][9].

Inlay scaffolds: Positioned between tendon and bone at the footprint. Ten of 13 preclinical studies in a systematic review showed positive outcomes for inlay positioning [8]. Demineralized bone matrix (DBM)/demineralized cortical bone was the most commonly investigated inlay scaffold (6 of 13 studies), followed by synthetic scaffolds and collagen scaffolds [8].

Tear Types Suited for Augmentation

Indications: EnFix usage is indicated for large to massive rotator cuff tears, tears with poor tendon quality, and revision surgeries [2].

Other Applications: EnFix has also been used in proximal/distal biceps tenodesis, insertional Achilles tendinopathy, gluteus medius and proximal hamstring reattachment, lateral epicondyle repair, and subscapularis repair during total shoulder arthroplasty [1].

Clinical Presentation

Patient factors increasing the risk of re-tear include age, tear size, fatty infiltration (Goutallier classification), tendon quality, osteoporosis, diabetes, and smoking status [2]. Patients older than 70 years and those with larger, retracted tears have higher rates of failure and are candidates for biologic augmentation [10]. Retear rate after repair of massive, retracted rotator cuff tears can be as high as 94% [2].

In the Gupta clinical study, the majority of patients had at least two-tendon tears with Patte 2-3 retraction and low-grade fatty infiltration (Goutallier 0-2) [2]. Functional shoulder strength is significantly better in patients with a healed tendon; tear progression holds high risk for significant dysfunction and pain [5].

Investigations

MRI: Pre-operative MRI arthrogram with 3.0-T is used to assess degree of tendon retraction (Patte classification), severity of fatty infiltration (Goutallier classification), and remaining tendon stump length [2]. Tendon retraction classified using Patte system: A (minimal retraction), B (retraction to humeral head), C (retraction to glenoid) [2][6]. Fatty infiltration classified using Goutallier system modified by Fuchs et al., simplified to low-grade (0-2) and high-grade (3-4) [2]. Tendon thickness is measured on T2-weighted coronal oblique sequences, perpendicular to the thickest portion of the tendon at the footprint near the repair anchors [2].

Post-operative non-contrast MRI at 6 months assesses tendon healing and quality using the Sugaya classification (Types I-V) [2]. At 6-month post-operative MRI in an EnFix-augmented patient, excellent healing of the supraspinatus tendon repair was demonstrated with clear tendon-to-bone integration, with morphology similar to a native tendon-bone interface [1]. MRI showed nearly no visible evidence of the EnFix RC implant such as marrow edema, cystic change, or adverse localized soft tissue reaction, with successful integration into surrounding bone [1].

Treatment

Operative

Surgical Approach / Technique: The EnFix biological scaffold can be integrated into double-row, single-row, or anchor-augmented rotator cuff repairs. For a double-row repair with the EnFix TAC, the patient is positioned in the beach-chair with 30 degrees of hip flexion; standard posterior viewing, anterior interval, lateral, and accessory anterolateral portals are established [9]. Diagnostic arthroscopy is performed, followed by subacromial bursectomy, decompression, debridement of torn tendon edges, and decortication of the greater tuberosity footprint [9]. Two double-loaded medial-row 2.6mm all-suture anchors are placed 8-10mm apart, with all 8 sutures passed through the rotator cuff in a mattress configuration [9]. Before lateral-row anchoring, the EnFix TAC implant is placed between the bone and the inferior aspect of the repaired tendon at the footprint [9]. An awl creates a pilot hole in the center of the tuberosity, a punch creates a flush circular bone cutout, and the implant is tapped into position flush with the surrounding bone [9]. The previously passed mattress sutures are brought down to the lateral row in an over-the-top fashion, and two lateral-row 4.75mm biocomposite anchors secure the transosseous-equivalent double-row repair [9]. This technique adds little-to-no increased surgical time, and scaffold placement is similar to anchor deployment [9].

For a single-row repair with EnFix, the patient is positioned in the lateral decubitus position with standard posterior, anterior, and lateral portals established [10]. A trough is created medially with an arthroscopic burr at the footprint of the torn tendon where the tendon will lie on repair [10]. Sutures are passed in a mattress configuration and shuttled anteriorly [10]. A cutting awl with a circular blade creates a 2mm-deep circle in the trough for implant placement, which also vents the proximal humerus to release marrow elements [10]. One or two EnFix implants are placed depending on tear size and tapped gently into position [10]. A single-row knotless repair is completed with double- or triple-loaded anchors placed lateral to the trough and implants [10]. This technique re-creates the enthesis with tendon contacting decorticated bone both inferior and lateral to the tendon edge [10].

When using EnFix RC with an anchor, the implant is placed into the awl hole created for the suture anchor and held in place using the suture anchor [1][3]. The implant is tapered with four ribs designed to resist rotation during suture anchor insertion [1]. Use of EnFix RC does not require the surgeon to change their surgical technique and adds less than 2 minutes to surgery time [1]. The peg portion enhances fixation of the suture anchor into bone, analogous to TheraCell's Fibrant pedicle screw fixation enhancement [1].

In the Gupta technique for augmentation, indications include large to massive cuff tears, poor tendon quality, and revision surgeries [2]. Surgery is performed in the beach-chair position under combined general anaesthetic and interscalene nerve block [2]. After adequate releases and muscle slide/advancement with suprascapular nerve release for massive retracted tears to ensure tension-free repair, EnFix RC is inserted onto the footprint adjacent to planned anchor placement near the medial row or between medial and lateral rows [2]. A standard double-row repair is performed using 5.5mm PEEK Quattro X medial row anchors and 5.5mm PEEK Quattro Link Knotless lateral row anchors (Zimmer Biomet) [2]. For delaminated tears, separate repair of deep and superficial layers is performed using the double layer Lasso loop technique [2].

Augmentation Strategy: In a systematic review, 10 of 13 preclinical studies showed qualitative or quantitative differences in favor of inlay scaffold augmentation over controls [8]. DBM/DCB inlay studies reported that 4 of 6 showed enhanced histology, biomechanical features, and bone mineral density at the repaired enthesis vs controls [8]. Two clinical studies of inlay scaffolds (non-DBM) reported lower failure rates (9% and 5.8% at the tendon-bone interface) than the established onlay literature (11.8%) [8]. Although onlay grafts reinforce the tendon, they do not recreate or enhance the native enthesis at the bone-tendon interface where most repairs fail [8][9].

Complications

Re-tear Rates

Infection (PJI): No re-tears were observed in the Gupta matched cohort study (31 augmented, 31 control) at 6 months, with a 100% healing rate in both groups [2]. In a retrospective review of 94 cases, one Australian surgeon reported a pre-EnFix failure rate of 8.3% versus a post-EnFix failure rate of 5.3%, representing a 36% reduction [1].

Aseptic loosening: In complex rotator cuff tears augmented with DBM (Flexigraft) plus PRP and cBMA, Wellington et al. reported 50% MRI-determined failure of supraspinatus healing [6]. These were complex/revision cases without a control group, and the failure rate was similar to rates previously described for such repairs (39.8-70%) [6]. The Wellington study acknowledged that concomitant use of PRP and cBMA made it difficult to isolate the effect of DBM alone [6].

Safety Profile

Wound complications: EnFix products are 100% cortical bone allograft with no additives or excipients, conforming to minimal tissue manipulation as defined by the FDA [1]. In all preclinical studies, no evidence of infection, rejection, or untoward immune reactions was noted [5][7]. In the canine model, no clinical signs of infection, dehiscence, or implant problems were noted in any dog during the 12-week study period [5]. In the rabbit model, 3 of 26 rabbits (2 control, 1 DBM) developed postoperative deep infections and were excluded; the infections were not attributable to DBM [7].

Nerve palsy: MRI at 6 months showed nearly no visible evidence of EnFix RC such as marrow edema, cystic change, or adverse localized soft tissue reaction [1]. DBM technology is well-established and safe for clinical use, with extensive use in spinal surgery as a bone void filler and graft material [2]. Compared to xenograft-based or synthetic grafts, DBM may produce less of an inflammatory response [10].

Recovery

Rehabilitation Protocol

Light activity (weeks): Desk work, driving, and light activities of daily living are typically permitted within the first 2–6 weeks, contingent on the specific surgical technique and repair construct.

Full activity (months): Manual work, sport participation, and full range of motion/strength return generally occur between 3 and 4 months post-operatively.

Complete recovery / outcome plateau (months): Pain, strength, and final functional outcomes stabilize by 4–6 months.

Rehabilitation protocol: Immobilisation and physical therapy phasing vary by technique. In the Gupta study, an abduction sling was maintained for 6 weeks; gentle passive range of motion (ROM) began on day 1, active-assisted ROM at 2 weeks, active ROM at 6 weeks, and strengthening commenced at 12 weeks [2]. For the Villarreal double-row technique, an abduction sling was used for 6 weeks; physical therapy initiated at 2 weeks included pendulum and wrist/elbow exercises, with active-assisted and passive motion at 6 weeks, active motion at 8 weeks, and strengthening at 14–16 weeks [9]. In the Papp single-row technique, an abduction sling with a pillow was maintained for 6 weeks; pendulum exercises began immediately, formal physical therapy started at 7–10 days, gentle passive motion at 3 weeks, gentle active-assisted motion at weeks 4–5, and active ROM at 6 weeks. If the repair includes side-to-side stitches, the formal protocol is delayed to 4–6 weeks [10].

Functional milestones: Preclinical models demonstrate accelerated healing and improved mechanical properties with biological scaffolds. In a rabbit infraspinatus repair model, DBF-treated repairs required 21% greater force at 6 weeks and 26% greater force at 12 weeks to detach tendon from bone compared to controls [1][3]. In the canine model at 12 weeks, DBM-PRP repairs achieved 66% of normal canine infraspinatus stiffness and 37% of normal failure load [5]. In the rabbit model (Lee et al.), at 8 weeks after repair of chronic supraspinatus tears, the DBM group showed organized collagen fibers with large quantities of fibrocartilage and mineralized fibrocartilage at the tendon-bone interface, whereas the control group showed disorganized fibrous tissue [7].

Other Considerations: Healing timelines from preclinical models indicate rapid tissue integration. In the sheep enthesis model, histology at 12 weeks showed enthesis reformation with Sharpey's fibers in the DBF-treated group but not in controls [1][3]. In the rabbit critical-sized femoral defect model, rapid bone formation was observed at 2 weeks with complete remodeling of DBF into bone at 4 weeks [1]. In a sheep screw study, new bone formation occurred around screw threads facilitated by DBF fibers at 4 weeks, with all DBF remodeled into new woven bone by 12 weeks [1].

See Also

References

[1] Carter AJ, McRury I, Patt BE. EnFix Implants for Enthesis Repair. White Paper, Doc. M24-001 Rev. 04. Tetrous, Inc., 2024.

[2] Banic A, Italia K, Child C, Maharaj J, Whitehouse S, Gupta A. Early clinical and radiologic outcomes after arthroscopic rotator cuff repair augmented with a demineralized bone fiber implant. Submitted to J Clin Med, 2025.

[3] Tetrous, Inc. EnFix Brochure - Shoulder. P5016 Rev. 01, 2025.

[4] Rodeo SA, Potter HG, Kawamura S, Turner AS, Kim HJ, Atkinson BL. Biologic augmentation of rotator cuff tendon-healing with use of a mixture of osteoinductive growth factors. J Bone Joint Surg Am. 2007;89(11):2485-2497. doi:10.2106/JBJS.C.01627.

[5] Smith MJ, Pfeiffer FM, Cook CR, Kuroki K, Cook JL. Rotator cuff healing using demineralized cancellous bone matrix sponge interposition compared to standard repair in a preclinical canine model. J Orthop Res. 2018;36(3):906-912. doi:10.1002/jor.23680.

[6] Wellington IJ, Muench LN, Hawthorne BC, et al. Clinical outcomes following biologically enhanced demineralized bone matrix augmentation of complex rotator cuff repair. J Clin Med. 2022;11(11):2956. doi:10.3390/jcm11112956.

[7] Lee WY, Kim YM, Hwang DS, et al. Does demineralized bone matrix enhance tendon-to-bone healing after rotator cuff repair in a rabbit model? Clin Orthop Surg. 2021;13(2):216-222. doi:10.4055/cios20099.

[8] Villarreal-Espinosa JB, Berreta RS, Boden SA, et al. Inlay scaffold augmentation of rotator cuff repairs enhances histologic resemblance to native enthesis in animal studies: a systematic review. Arthroscopy. 2024;41(6):2048-2060. doi:10.1016/j.arthro.2024.06.048.

[9] Villarreal-Espinosa JB, Saad-Berreta R, Danilkowicz R, et al. Arthroscopic transosseous-equivalent double-row rotator cuff repair augmentation with interpositional demineralized bone fiber implant. Arthrosc Tech. 2024;13(12):103133. doi:10.1016/j.eats.2024.103133.

[10] Goodwin TM, Davidson A, Lerebours FR, Zikria BA, Miniaci A, Papp DF. Arthroscopic single-row rotator cuff repair augmentation with interpositional demineralized bone fiber implant. Arthrosc Tech. 2025;14(11):103880. doi:10.1016/j.eats.2025.103880.

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b. To the extent possible, if any provision of this Public License is deemed unenforceable, it shall be automatically reformed to the minimum extent necessary to make it enforceable. If the provision cannot be reformed, it shall be severed from this Public License without affecting the enforceability of the remaining terms and conditions.

c. No term or condition of this Public License will be waived and no failure to comply consented to unless expressly agreed to by the Licensor.

d. Nothing in this Public License constitutes or may be interpreted as a limitation upon, or waiver of, any privileges and immunities that apply to the Licensor or You, including from the legal processes of any jurisdiction or authority.

Creative Commons is not a party to its public licenses. Notwithstanding, Creative Commons may elect to apply one of its public licenses to material it publishes and in those instances will be considered the “Licensor.” The text of the Creative Commons public licenses is dedicated to the public domain under the CC0 Public Domain Dedication. Except for the limited purpose of indicating that material is shared under a Creative Commons public license or as otherwise permitted by the Creative Commons policies published at creativecommons.org/policies, Creative Commons does not authorize the use of the trademark "Creative Commons" or any other trademark or logo of Creative Commons without its prior written consent including, without limitation, in connection with any unauthorized modifications to any of its public licenses or any other arrangements, understandings, or agreements concerning use of licensed material. For the avoidance of doubt, this paragraph does not form part of the public licenses.

Creative Commons may be contacted at creativecommons.org.