Measurement error of lumbar total disc replacement range of motion

Moe R. Lim, Randall Loder, Russel C. Huang, Stephen Lyman, Kai Zhang, Andrew Sama, Elias C. Papadopoulos, Kristin Warner, Federico P. Girardi, Frank P. Cammisa

Research output: Contribution to journalArticle

31 Citations (Scopus)

Abstract

Study Design. A retrospective review of lumbar total disc replacement (TDR) radiographs. Objective. To determine the error and variability in measuring TDR radiographic range of motion (ROM). Summary of Background Data. Motion preservation is the driving force behind lumbar TDR technology. In the recent literature, sagittal radiographic TDR ROM as low as 2° has been reported. In these studies, ROM was determined by using the Cobb method to measure TDR sagittal alignment angles in flexion-extension lateral radiographs. However, previous studies in the spinal deformity literature have shown that the Cobb method is very susceptible to measurement error. Methods. There were 5 observers, including 2 attending orthopedic spine surgeons, 1 spine fellow, 1 fifth-year resident, and 1 fourth-year resident, who measured the ROM of 50 ProDisc II (Synthes Spine Solutions, New York, NY) TDRs on standard flexion-extension lumbar spine radiograph sets. Repeated measurements were made on 2 occasions using the Cobb method. Measurement variability was calculated using 3 statistical methods. Results. The 3 statistical methods resulted in extremely similar values for TDR ROM observer variability. Overall, the intraobserver variability of TDR ROM measurement was ±4.6°, and interobserver variability was ±5.2°. Conclusions. To be 95% certain that an implanted TDR prosthesis has any sagittal motion, a ROM of at least 4.6° must be observed, which is the upper limit of intraobserver measurement variability for a TDR with a true ROM of 0°. To be 95% certain that a change in TDR ROM has occurred between 2 measurements by the same observer, a change in ROM of at least 9.6° must be observed (the entire range of ±4.6° intraobserver variability). ROM measurement variability should be considered when evaluating the success or failure of motion preservation in lumbar TDR.

Original languageEnglish
JournalSpine
Volume31
Issue number10
DOIs
StatePublished - May 2006

Fingerprint

Total Disc Replacement
Articular Range of Motion
Observer Variation
Spine
Prostheses and Implants

Keywords

  • Error
  • Lumbar
  • Measurement variability
  • Range of motion
  • Total disc replacement

ASJC Scopus subject areas

  • Physiology
  • Clinical Neurology
  • Orthopedics and Sports Medicine

Cite this

Lim, M. R., Loder, R., Huang, R. C., Lyman, S., Zhang, K., Sama, A., ... Cammisa, F. P. (2006). Measurement error of lumbar total disc replacement range of motion. Spine, 31(10). https://doi.org/10.1097/01.brs.0000216452.54421.ea

Measurement error of lumbar total disc replacement range of motion. / Lim, Moe R.; Loder, Randall; Huang, Russel C.; Lyman, Stephen; Zhang, Kai; Sama, Andrew; Papadopoulos, Elias C.; Warner, Kristin; Girardi, Federico P.; Cammisa, Frank P.

In: Spine, Vol. 31, No. 10, 05.2006.

Research output: Contribution to journalArticle

Lim, MR, Loder, R, Huang, RC, Lyman, S, Zhang, K, Sama, A, Papadopoulos, EC, Warner, K, Girardi, FP & Cammisa, FP 2006, 'Measurement error of lumbar total disc replacement range of motion', Spine, vol. 31, no. 10. https://doi.org/10.1097/01.brs.0000216452.54421.ea
Lim, Moe R. ; Loder, Randall ; Huang, Russel C. ; Lyman, Stephen ; Zhang, Kai ; Sama, Andrew ; Papadopoulos, Elias C. ; Warner, Kristin ; Girardi, Federico P. ; Cammisa, Frank P. / Measurement error of lumbar total disc replacement range of motion. In: Spine. 2006 ; Vol. 31, No. 10.
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abstract = "Study Design. A retrospective review of lumbar total disc replacement (TDR) radiographs. Objective. To determine the error and variability in measuring TDR radiographic range of motion (ROM). Summary of Background Data. Motion preservation is the driving force behind lumbar TDR technology. In the recent literature, sagittal radiographic TDR ROM as low as 2° has been reported. In these studies, ROM was determined by using the Cobb method to measure TDR sagittal alignment angles in flexion-extension lateral radiographs. However, previous studies in the spinal deformity literature have shown that the Cobb method is very susceptible to measurement error. Methods. There were 5 observers, including 2 attending orthopedic spine surgeons, 1 spine fellow, 1 fifth-year resident, and 1 fourth-year resident, who measured the ROM of 50 ProDisc II (Synthes Spine Solutions, New York, NY) TDRs on standard flexion-extension lumbar spine radiograph sets. Repeated measurements were made on 2 occasions using the Cobb method. Measurement variability was calculated using 3 statistical methods. Results. The 3 statistical methods resulted in extremely similar values for TDR ROM observer variability. Overall, the intraobserver variability of TDR ROM measurement was ±4.6°, and interobserver variability was ±5.2°. Conclusions. To be 95{\%} certain that an implanted TDR prosthesis has any sagittal motion, a ROM of at least 4.6° must be observed, which is the upper limit of intraobserver measurement variability for a TDR with a true ROM of 0°. To be 95{\%} certain that a change in TDR ROM has occurred between 2 measurements by the same observer, a change in ROM of at least 9.6° must be observed (the entire range of ±4.6° intraobserver variability). ROM measurement variability should be considered when evaluating the success or failure of motion preservation in lumbar TDR.",
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AU - Lim, Moe R.

AU - Loder, Randall

AU - Huang, Russel C.

AU - Lyman, Stephen

AU - Zhang, Kai

AU - Sama, Andrew

AU - Papadopoulos, Elias C.

AU - Warner, Kristin

AU - Girardi, Federico P.

AU - Cammisa, Frank P.

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N2 - Study Design. A retrospective review of lumbar total disc replacement (TDR) radiographs. Objective. To determine the error and variability in measuring TDR radiographic range of motion (ROM). Summary of Background Data. Motion preservation is the driving force behind lumbar TDR technology. In the recent literature, sagittal radiographic TDR ROM as low as 2° has been reported. In these studies, ROM was determined by using the Cobb method to measure TDR sagittal alignment angles in flexion-extension lateral radiographs. However, previous studies in the spinal deformity literature have shown that the Cobb method is very susceptible to measurement error. Methods. There were 5 observers, including 2 attending orthopedic spine surgeons, 1 spine fellow, 1 fifth-year resident, and 1 fourth-year resident, who measured the ROM of 50 ProDisc II (Synthes Spine Solutions, New York, NY) TDRs on standard flexion-extension lumbar spine radiograph sets. Repeated measurements were made on 2 occasions using the Cobb method. Measurement variability was calculated using 3 statistical methods. Results. The 3 statistical methods resulted in extremely similar values for TDR ROM observer variability. Overall, the intraobserver variability of TDR ROM measurement was ±4.6°, and interobserver variability was ±5.2°. Conclusions. To be 95% certain that an implanted TDR prosthesis has any sagittal motion, a ROM of at least 4.6° must be observed, which is the upper limit of intraobserver measurement variability for a TDR with a true ROM of 0°. To be 95% certain that a change in TDR ROM has occurred between 2 measurements by the same observer, a change in ROM of at least 9.6° must be observed (the entire range of ±4.6° intraobserver variability). ROM measurement variability should be considered when evaluating the success or failure of motion preservation in lumbar TDR.

AB - Study Design. A retrospective review of lumbar total disc replacement (TDR) radiographs. Objective. To determine the error and variability in measuring TDR radiographic range of motion (ROM). Summary of Background Data. Motion preservation is the driving force behind lumbar TDR technology. In the recent literature, sagittal radiographic TDR ROM as low as 2° has been reported. In these studies, ROM was determined by using the Cobb method to measure TDR sagittal alignment angles in flexion-extension lateral radiographs. However, previous studies in the spinal deformity literature have shown that the Cobb method is very susceptible to measurement error. Methods. There were 5 observers, including 2 attending orthopedic spine surgeons, 1 spine fellow, 1 fifth-year resident, and 1 fourth-year resident, who measured the ROM of 50 ProDisc II (Synthes Spine Solutions, New York, NY) TDRs on standard flexion-extension lumbar spine radiograph sets. Repeated measurements were made on 2 occasions using the Cobb method. Measurement variability was calculated using 3 statistical methods. Results. The 3 statistical methods resulted in extremely similar values for TDR ROM observer variability. Overall, the intraobserver variability of TDR ROM measurement was ±4.6°, and interobserver variability was ±5.2°. Conclusions. To be 95% certain that an implanted TDR prosthesis has any sagittal motion, a ROM of at least 4.6° must be observed, which is the upper limit of intraobserver measurement variability for a TDR with a true ROM of 0°. To be 95% certain that a change in TDR ROM has occurred between 2 measurements by the same observer, a change in ROM of at least 9.6° must be observed (the entire range of ±4.6° intraobserver variability). ROM measurement variability should be considered when evaluating the success or failure of motion preservation in lumbar TDR.

KW - Error

KW - Lumbar

KW - Measurement variability

KW - Range of motion

KW - Total disc replacement

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