Biopsy Proven Focal Osteolysis in a Stainless-Steel Limb-Lengthening Device: A Report of Three Cases

Sax, Oliver C.; Molavi, Diana Weedman; Herzenberg, John E.; Standard, Shawn C.; McClure, Philip K.

doi:10.5435/jaaosglobal-d-21-00101

Cited by 6 publications

(24 citation statements)

References 21 publications

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“…A similar report by Frommer et al [ 20 ] identified osteolytic changes in 20 of the 57 (35%) implanted nails at a mean 9.5 months after index lengthening surgery. They also found macroscopic corrosion at the modular junction in 83% of recipients, similar to that reported by our group in a previous publication [ 19 ] and a separate analysis of retrieved nails at another institution [ 30 ]. In a comparative study of multiple variations of an intramedullary limb lengthening nail, Iobst et al [ 29 ] observed a greater proportion of bone abnormalities at the modular junction of the STRYDE nail, as compared to the PRECICE or FITBONE (Orthofix Medical Inc., Lewisville, TX, USA).…”

Section: Discussionsupporting

confidence: 87%

“…The modular components within the stainless-steel intramedullary limb lengthening nail are subject to produce wear particles and a macrophage-driven adverse tissue reaction. Reports of osteolysis between similar designs are largely limited to total hip arthroplasty (THA); though recent reports have suggested this process in intramedullary lengthening nails [ 19 , 20 , 21 , 22 , 23 , 24 ]. We sought to examine the total number of stainless-steel nail recipients for LLD at a single tertiary care center to determine the incidence of adverse tissue reaction before and following routine explantation.…”

Section: Discussionmentioning

confidence: 99%

“…Since a manufacturer recall in early 2021, multiple reports have demonstrated the presence of adverse tissue reactions in stainless-steel intramedullary lengthening nails [ 19 , 20 , 21 , 22 , 23 , 24 , 29 , 30 ]. In a report of three cases, Sax et al [ 19 ] demonstrated radiographic osteolysis in patients implanted with the stainless-steel nail with histologic confirmation of phagocytic activity of green-gold crystalline debris characteristic of metal debris. Other institutional studies have also found adverse tissue reactions in a substantial proportion of their patients.…”

Section: Discussionmentioning

confidence: 99%

“…The primary outcome was presence of adverse tissue reactions after explantation. Adverse tissue reaction was defined as periosteal reaction or osteolysis as classified according to a novel and validated classification system (Biologic Reaction Classification System, as reported by Sax et al [ 24 ]) by five fellowship-trained surgeons. (See Figure 1 ) This system was developed assessing routine anterior-posterior and lateral standing radiographs for each patient.…”

Section: Methodsmentioning

confidence: 99%

“…The modular junction of stainless-steel intramedullary lengthening nails used for limb lengthening may also be subject to similar changes. In fact, several recent reports have come to light that suggest this process in the stainless-steel intramedullary lengthening device [ 19 , 20 , 21 , 22 , 23 , 24 ]. However, given these relative newfound insights into the possibility of adverse tissue reactions with this recently introduced lengthening nail, there are no reports describing potential post-explantation resolution.…”

Section: Introductionmentioning

confidence: 99%

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Does Focal Osteolysis in a PRECICE Stryde Intramedullary Lengthening Nail Resolve after Explantation?

Sax¹,

Hlukha²,

Kowalewski³

et al. 2022

Children

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Concerns surrounding osteolysis near and around the modular junction of a stainless-steel intramedullary lengthening rod prompted a manufacturer recall from the market in early 2021. These actions were preceded by similar steps taken in Europe. A concomitant review of stainless-steel lengthenings at our institution demonstrated signs of adverse tissue reaction including periosteal reaction and osteolysis at the modular junction and/or male-sided locking screws. Nearly half of our patients presented with these findings on radiographic images. At the time of the previous review, only half of the nearly 60 implanted stainless-steel devices met a 6-month follow up. At this juncture, many patients have had their devices explanted. Given the suspected adverse tissue reactions caused by a component of the internal device, we sought to examine the rate of osteolysis post-explantation following removal of a stainless-steel nail. We reviewed a consecutive series of patients who underwent implantation of a stainless-steel limb lengthening device in the femur and/or tibia at a single institution between December 2018 and December 2020. Patients were included if their device was explanted. Periosteal reaction and osteolysis was classified according to a novel and validated classification system, as analyzed by five fellowship-trained surgeons. In addition, changes observed prior to explantation were tracked post-explantation to assess for resolution. The incidence of periosteal reaction and osteolysis prior to explantation was 22/57 (39%) and 15/57 (26%), respectively. Of the 15 patients with osteolysis pre-explantation, 14 patients’ implants were explanted. Of these, eight patients had available follow up films. Two patients were identified as having partial osteolysis resolution at mean 1-year follow up, while six patients were identified as having complete osteolysis at mean 18-months follow up. Periosteal tissue reaction and osteolysis largely resolved following explantation in a subset of patients. These results provide further support to the claim that the stainless-steel device contributed to the changes seen. Further follow-up is warranted to examine the longer-term effects of adverse tissue reaction in this patient population.

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Section: Discussionsupporting

confidence: 87%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

Does Focal Osteolysis in a PRECICE Stryde Intramedullary Lengthening Nail Resolve after Explantation?

Sax¹,

Hlukha²,

Kowalewski³

et al. 2022

Children

Self Cite

View full text Add to dashboard Cite

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Incidence of Focal Osteolysis in a Titanium Limb-Lengthening Device: A Comparison to a Stainless-Steel Model

Sax,

Hlukha,

Kowalewski

et al. 2023

Journal of Orthopaedic Trauma

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Objectives: To evaluate 1 manufacturer's titanium intramedullary lengthening nail (ILN) for radiographic evidence of adverse tissue reactions similar to those in their stainless-steel ILN that was recalled in 2021, with specific outcomes of (1) incidence of periosteal reaction and osteolysis and (2) adverse tissue reaction-related device failures. Design: Radiographic review of consecutive patients with ≥1-year clinical follow-up who received 1 manufacturer's ILNs implanted in the femur and/or tibia from February 2012 to July 2021. Setting: Single tertiary-care center. Patients/Participants: Two hundred twenty-six limbs with titanium ILNs and 57 limbs with stainless-steel ILNs. Intervention: Precice titanium ILN (NuVasive Specialized Orthopedics, San Diego, CA) and Stryde stainless-steel ILN (NuVasive Specialized Orthopedics). Main Outcome Measurements: Radiographic outcome data and complications. Results: Of 226 limbs with titanium ILNs, 160 (70.8%) had periosteal reaction, and 2 (0.9%) had osteolysis. Periosteal reaction and osteolysis rates in stainless-steel ILNs (57 limbs) were 39% and 26%, respectively. No adverse tissue reaction-related device failures were noted with titanium. Several other complications presented, notably hip and/or knee tissue contracture (141), consolidation problems (8), and needing peroneal nerve decompression (14). Conclusions: Osteolysis incidence was substantially less among the titanium population, supporting the claim that observed osteolysis in the stainless-steel cohort was attributed to its construct. On average, periosteal reaction was radiographically appreciated later in patients with titanium than stainless steel. Further study is needed to confirm this finding. Level of Evidence: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

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A clinical and radiological matched-pair analysis of patients treated with the PRECICE and STRYDE magnetically driven motorized intramedullary lengthening nails

Vogt

Rupp

Gosheger

et al. 2023

The Bone & Joint Journal

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Aims Distraction osteogenesis with intramedullary lengthening devices has undergone rapid development in the past decade with implant enhancement. In this first single-centre matched-pair analysis we focus on the comparison of treatment with the PRECICE and STRYDE intramedullary lengthening devices and aim to clarify any clinical and radiological differences. Methods A single-centre 2:1 matched-pair retrospective analysis of 42 patients treated with the STRYDE and 82 patients treated with the PRECICE nail between May 2013 and November 2020 was conducted. Clinical and lengthening parameters were compared while focusing radiological assessment on osseous alterations related to the nail’s telescopic junction and locking bolts at four different stages. Results Osteolysis next to the telescopic junction was observed in 31/48 segments (65%) lengthened with the STRYDE nail before implant removal compared to 1/91 segment (1%) in the PRECICE cohort. In the STRYDE cohort, osteolysis initially increased, but decreased or resolved in almost all lengthened segments (86%) after implant removal. Implant failure was observed in 9/48 STRYDE (19%) and in 8/92 PRECICE nails (9%). Breakage of the distal locking bolts was found in 5/48 STRYDE nails (10%) compared to none in the PRECICE cohort. Treatment-associated pain was generally recorded as mild and found in 30/48 patients (63%) and 39/92 (42%) in the STRYDE and PRECICE cohorts, respectively. Temporary range of motion (ROM) limitations under distraction were registered in 17/48 (35%) segments treated with the STRYDE and 35/92 segments (38%) treated with the PRECICE nail. Conclusion Osteolysis and periosteal reaction, implant breakage, and pain during lengthening and consolidation is more likely in patients treated with the STRYDE nail compared to the PRECICE nail. Temporary ROM limitations during lengthening occurred independent of the applied device. Implant-related osseous alterations seem to remodel after implant removal. Cite this article: Bone Joint J 2023;105-B(1):88–96.

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Biopsy Proven Focal Osteolysis in a Stainless-Steel Limb-Lengthening Device: A Report of Three Cases

Cited by 6 publications

References 21 publications

Does Focal Osteolysis in a PRECICE Stryde Intramedullary Lengthening Nail Resolve after Explantation?

Does Focal Osteolysis in a PRECICE Stryde Intramedullary Lengthening Nail Resolve after Explantation?

Incidence of Focal Osteolysis in a Titanium Limb-Lengthening Device: A Comparison to a Stainless-Steel Model

A clinical and radiological matched-pair analysis of patients treated with the PRECICE and STRYDE magnetically driven motorized intramedullary lengthening nails

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