Complications of the Intramedullary Skeletal Kinetic Distractor (ISKD) in distraction osteogenesis

Dong H oon Lee, Keun J ung Ryu, Hae R yong Song, Soo Hong Han

Research output: Contribution to journalArticle

21 Citations (Scopus)

Abstract

BACKGROUND: The Intramedullary Skeletal Kinetic Distractor (ISKD) (Orthofix Inc, Lewisville, TX, USA) is an intramedullary device designed for more comfortable limb lengthening than that with external fixators; lengthening is achieved with this nail using rotational oscillation between two telescoping sections. However, the degree to which this device achieves this goal and its complication rate have not been fully documented.

QUESTIONS/PURPOSES: We determined (1) the frequency with which distraction was not achieved at the desired rate, (2) whether pain differed between patients with normally and abnormally distracting nails, (3) risk factors for abnormal nails, and (4) other complications.

METHODS: We analyzed 35 lengthening segments (26 femurs, nine tibias) in 19 patients. Mean length achieved was 47 mm. Femoral nails were categorized into four groups according to distraction rate: normal, runaway (unintentionally faster rate [> 1.5 mm/day]), difficult-to-distract (slower rate [< 0.8 mm/day] requiring manual manipulation but not requiring general anesthesia), and nondistracting (slower rate [< 0.8 mm/day] requiring manual manipulation under general anesthesia or reosteotomy). Possible risk factors, including age, BMI, preoperative thigh circumferences, degree of intramedullary overreaming, and length of the thicker portion of the nail within the distal fragment, were compared among groups. VAS pain scores were compared among groups under three conditions: rest, physiotherapy, and distraction motion. Complications were also analyzed. Minimum followup was 15 months (mean, 26 months; range, 15-38 months) after first-stage surgery.

RESULTS: Abnormal distraction rate was observed in 21 of 35 segments (60%; 17 femurs, four tibias). VAS pain scores showed no differences among groups during rest or physiotherapy but were higher (p = 0.02) in the problematic nails (7-8 points) versus normal nails (3 points) during distraction. Only mean length of the thicker portion of the nail within the distal fragment differed between normally and abnormally distracting nails (95 mm versus 100 mm; p = 0.03), although this was unlikely to be clinically important. Complications occurred in 10 patients (53%), including five with decreased ankle ROM during distraction, four with delayed bone healing, and one with mechanical device failure during distraction.

CONCLUSIONS: Rate control was difficult to achieve with the ISKD nail for femoral and tibial lengthenings, complications were relatively common, and among patients in whom rate control was not achieved, pain levels were high. Based on our findings, we believe that surgeons should avoid use of this nail.

LEVEL OF EVIDENCE: Level IV, therapeutic study. See Instructions for Authors for a complete description of levels of evidence.

Original languageEnglish
Pages (from-to)3852-3859
Number of pages8
JournalClinical Orthopaedics and Related Research
Volume472
Issue number12
DOIs
Publication statusPublished - 2014 Dec 1
Externally publishedYes

Fingerprint

Distraction Osteogenesis
Nails
Thigh
Pain
Tibia
Femur
General Anesthesia
Malformed Nails
Equipment Failure
Telescopes
Homeless Youth
External Fixators
Equipment and Supplies
Ankle
Extremities

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Complications of the Intramedullary Skeletal Kinetic Distractor (ISKD) in distraction osteogenesis. / Lee, Dong H oon; Ryu, Keun J ung; Song, Hae R yong; Han, Soo Hong.

In: Clinical Orthopaedics and Related Research, Vol. 472, No. 12, 01.12.2014, p. 3852-3859.

Research output: Contribution to journalArticle

@article{bbe193aebd314a02873994d5ca1d2818,
title = "Complications of the Intramedullary Skeletal Kinetic Distractor (ISKD) in distraction osteogenesis",
abstract = "BACKGROUND: The Intramedullary Skeletal Kinetic Distractor (ISKD) (Orthofix Inc, Lewisville, TX, USA) is an intramedullary device designed for more comfortable limb lengthening than that with external fixators; lengthening is achieved with this nail using rotational oscillation between two telescoping sections. However, the degree to which this device achieves this goal and its complication rate have not been fully documented.QUESTIONS/PURPOSES: We determined (1) the frequency with which distraction was not achieved at the desired rate, (2) whether pain differed between patients with normally and abnormally distracting nails, (3) risk factors for abnormal nails, and (4) other complications.METHODS: We analyzed 35 lengthening segments (26 femurs, nine tibias) in 19 patients. Mean length achieved was 47 mm. Femoral nails were categorized into four groups according to distraction rate: normal, runaway (unintentionally faster rate [> 1.5 mm/day]), difficult-to-distract (slower rate [< 0.8 mm/day] requiring manual manipulation but not requiring general anesthesia), and nondistracting (slower rate [< 0.8 mm/day] requiring manual manipulation under general anesthesia or reosteotomy). Possible risk factors, including age, BMI, preoperative thigh circumferences, degree of intramedullary overreaming, and length of the thicker portion of the nail within the distal fragment, were compared among groups. VAS pain scores were compared among groups under three conditions: rest, physiotherapy, and distraction motion. Complications were also analyzed. Minimum followup was 15 months (mean, 26 months; range, 15-38 months) after first-stage surgery.RESULTS: Abnormal distraction rate was observed in 21 of 35 segments (60{\%}; 17 femurs, four tibias). VAS pain scores showed no differences among groups during rest or physiotherapy but were higher (p = 0.02) in the problematic nails (7-8 points) versus normal nails (3 points) during distraction. Only mean length of the thicker portion of the nail within the distal fragment differed between normally and abnormally distracting nails (95 mm versus 100 mm; p = 0.03), although this was unlikely to be clinically important. Complications occurred in 10 patients (53{\%}), including five with decreased ankle ROM during distraction, four with delayed bone healing, and one with mechanical device failure during distraction.CONCLUSIONS: Rate control was difficult to achieve with the ISKD nail for femoral and tibial lengthenings, complications were relatively common, and among patients in whom rate control was not achieved, pain levels were high. Based on our findings, we believe that surgeons should avoid use of this nail.LEVEL OF EVIDENCE: Level IV, therapeutic study. See Instructions for Authors for a complete description of levels of evidence.",
author = "Lee, {Dong H oon} and Ryu, {Keun J ung} and Song, {Hae R yong} and Han, {Soo Hong}",
year = "2014",
month = "12",
day = "1",
doi = "10.1007/s11999-014-3547-4",
language = "English",
volume = "472",
pages = "3852--3859",
journal = "Clinical Orthopaedics and Related Research",
issn = "0009-921X",
publisher = "Springer New York",
number = "12",

}

TY - JOUR

T1 - Complications of the Intramedullary Skeletal Kinetic Distractor (ISKD) in distraction osteogenesis

AU - Lee, Dong H oon

AU - Ryu, Keun J ung

AU - Song, Hae R yong

AU - Han, Soo Hong

PY - 2014/12/1

Y1 - 2014/12/1

N2 - BACKGROUND: The Intramedullary Skeletal Kinetic Distractor (ISKD) (Orthofix Inc, Lewisville, TX, USA) is an intramedullary device designed for more comfortable limb lengthening than that with external fixators; lengthening is achieved with this nail using rotational oscillation between two telescoping sections. However, the degree to which this device achieves this goal and its complication rate have not been fully documented.QUESTIONS/PURPOSES: We determined (1) the frequency with which distraction was not achieved at the desired rate, (2) whether pain differed between patients with normally and abnormally distracting nails, (3) risk factors for abnormal nails, and (4) other complications.METHODS: We analyzed 35 lengthening segments (26 femurs, nine tibias) in 19 patients. Mean length achieved was 47 mm. Femoral nails were categorized into four groups according to distraction rate: normal, runaway (unintentionally faster rate [> 1.5 mm/day]), difficult-to-distract (slower rate [< 0.8 mm/day] requiring manual manipulation but not requiring general anesthesia), and nondistracting (slower rate [< 0.8 mm/day] requiring manual manipulation under general anesthesia or reosteotomy). Possible risk factors, including age, BMI, preoperative thigh circumferences, degree of intramedullary overreaming, and length of the thicker portion of the nail within the distal fragment, were compared among groups. VAS pain scores were compared among groups under three conditions: rest, physiotherapy, and distraction motion. Complications were also analyzed. Minimum followup was 15 months (mean, 26 months; range, 15-38 months) after first-stage surgery.RESULTS: Abnormal distraction rate was observed in 21 of 35 segments (60%; 17 femurs, four tibias). VAS pain scores showed no differences among groups during rest or physiotherapy but were higher (p = 0.02) in the problematic nails (7-8 points) versus normal nails (3 points) during distraction. Only mean length of the thicker portion of the nail within the distal fragment differed between normally and abnormally distracting nails (95 mm versus 100 mm; p = 0.03), although this was unlikely to be clinically important. Complications occurred in 10 patients (53%), including five with decreased ankle ROM during distraction, four with delayed bone healing, and one with mechanical device failure during distraction.CONCLUSIONS: Rate control was difficult to achieve with the ISKD nail for femoral and tibial lengthenings, complications were relatively common, and among patients in whom rate control was not achieved, pain levels were high. Based on our findings, we believe that surgeons should avoid use of this nail.LEVEL OF EVIDENCE: Level IV, therapeutic study. See Instructions for Authors for a complete description of levels of evidence.

AB - BACKGROUND: The Intramedullary Skeletal Kinetic Distractor (ISKD) (Orthofix Inc, Lewisville, TX, USA) is an intramedullary device designed for more comfortable limb lengthening than that with external fixators; lengthening is achieved with this nail using rotational oscillation between two telescoping sections. However, the degree to which this device achieves this goal and its complication rate have not been fully documented.QUESTIONS/PURPOSES: We determined (1) the frequency with which distraction was not achieved at the desired rate, (2) whether pain differed between patients with normally and abnormally distracting nails, (3) risk factors for abnormal nails, and (4) other complications.METHODS: We analyzed 35 lengthening segments (26 femurs, nine tibias) in 19 patients. Mean length achieved was 47 mm. Femoral nails were categorized into four groups according to distraction rate: normal, runaway (unintentionally faster rate [> 1.5 mm/day]), difficult-to-distract (slower rate [< 0.8 mm/day] requiring manual manipulation but not requiring general anesthesia), and nondistracting (slower rate [< 0.8 mm/day] requiring manual manipulation under general anesthesia or reosteotomy). Possible risk factors, including age, BMI, preoperative thigh circumferences, degree of intramedullary overreaming, and length of the thicker portion of the nail within the distal fragment, were compared among groups. VAS pain scores were compared among groups under three conditions: rest, physiotherapy, and distraction motion. Complications were also analyzed. Minimum followup was 15 months (mean, 26 months; range, 15-38 months) after first-stage surgery.RESULTS: Abnormal distraction rate was observed in 21 of 35 segments (60%; 17 femurs, four tibias). VAS pain scores showed no differences among groups during rest or physiotherapy but were higher (p = 0.02) in the problematic nails (7-8 points) versus normal nails (3 points) during distraction. Only mean length of the thicker portion of the nail within the distal fragment differed between normally and abnormally distracting nails (95 mm versus 100 mm; p = 0.03), although this was unlikely to be clinically important. Complications occurred in 10 patients (53%), including five with decreased ankle ROM during distraction, four with delayed bone healing, and one with mechanical device failure during distraction.CONCLUSIONS: Rate control was difficult to achieve with the ISKD nail for femoral and tibial lengthenings, complications were relatively common, and among patients in whom rate control was not achieved, pain levels were high. Based on our findings, we believe that surgeons should avoid use of this nail.LEVEL OF EVIDENCE: Level IV, therapeutic study. See Instructions for Authors for a complete description of levels of evidence.

UR - http://www.scopus.com/inward/record.url?scp=84925287354&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84925287354&partnerID=8YFLogxK

U2 - 10.1007/s11999-014-3547-4

DO - 10.1007/s11999-014-3547-4

M3 - Article

C2 - 24604112

VL - 472

SP - 3852

EP - 3859

JO - Clinical Orthopaedics and Related Research

JF - Clinical Orthopaedics and Related Research

SN - 0009-921X

IS - 12

ER -