An implantable shock absorber yields an 85% survival-from-arthroplasty rate through 5 years in working-age patients with medial compartment knee osteoarthritis
Purpose To evaluate the 5-year rate of survival without undergoing arthroplasty or high tibial osteotomy (HTO) in subjects with mild-to-moderate medial compartment knee osteoarthritis (OA) who were treated with an implantable shock absorber (ISA) system. Methods Three prospective, sequential, multic...
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Published in | Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA Vol. 31; no. 8; pp. 3307 - 3315 |
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Main Authors | , , , , , , |
Format | Journal Article |
Language | English |
Published |
Berlin/Heidelberg
Springer Berlin Heidelberg
01.08.2023
John Wiley & Sons, Inc |
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Abstract | Purpose
To evaluate the 5-year rate of survival without undergoing arthroplasty or high tibial osteotomy (HTO) in subjects with mild-to-moderate medial compartment knee osteoarthritis (OA) who were treated with an implantable shock absorber (ISA) system.
Methods
Three prospective, sequential, multicenter, international, single-arm clinical trials were conducted comprising subjects who received an ISA for symptomatic medial knee OA after failing ≥ 6 months of conservative therapy. Study outcomes were analyzed cumulatively and by enrollment group when all subjects’ follow-up data exceeded the 2-year threshold after ISA implantation. Primary outcome was survival rate without conversion to arthroplasty/HTO. Secondary outcomes were changes in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain and function scores after ISA implantation.
Results
All 171 enrolled subjects (age 51 ± 9 years, body-mass index 28.5 ± 3.5 kg/m
2
, 38% female; study knee Kellgren–Lawrence score 2.7 ± 0.9 points) were followed for a minimum of 2, and up to 5, years after device implantation. Overall, 90.6% (155/171) of subjects survived without requiring arthroplasty/HTO at last follow-up (mean 3.2 ± 1.6 years). The Kaplan–Meyer median 3- and 5-year survival-without-arthroplasty point estimates were 89.8% (95% CI 86.5‒95.7%) and 84.9% (95% CI 75.1‒91.1%), respectively. The median 3-year estimated survival rate for the most recent study (
n
= 81) was 97.3%. The mean WOMAC Pain score decreased 71% from baseline to last follow-up after ISA implantation, from 58 ± 13 to 16 ± 17 points (
p
< 0.0001). The Function score improved 69%, decreasing from 56 ± 18 to 17 ± 17 points (
p
< 0.0001).
Conclusions
In younger patients with mild-to-moderate symptomatic medial compartment knee OA, implantation of the ISA device resulted in a 5-year survival rate of 85% from undergoing arthroplasty or HTO. The ISA system may be an effective treatment option for working-age patients with medial knee OA who are not candidates for or do not desire more invasive surgical approaches.
Level of evidence
II. |
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AbstractList | To evaluate the 5-year rate of survival without undergoing arthroplasty or high tibial osteotomy (HTO) in subjects with mild-to-moderate medial compartment knee osteoarthritis (OA) who were treated with an implantable shock absorber (ISA) system.
Three prospective, sequential, multicenter, international, single-arm clinical trials were conducted comprising subjects who received an ISA for symptomatic medial knee OA after failing ≥ 6 months of conservative therapy. Study outcomes were analyzed cumulatively and by enrollment group when all subjects' follow-up data exceeded the 2-year threshold after ISA implantation. Primary outcome was survival rate without conversion to arthroplasty/HTO. Secondary outcomes were changes in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain and function scores after ISA implantation.
All 171 enrolled subjects (age 51 ± 9 years, body-mass index 28.5 ± 3.5 kg/m
, 38% female; study knee Kellgren-Lawrence score 2.7 ± 0.9 points) were followed for a minimum of 2, and up to 5, years after device implantation. Overall, 90.6% (155/171) of subjects survived without requiring arthroplasty/HTO at last follow-up (mean 3.2 ± 1.6 years). The Kaplan-Meyer median 3- and 5-year survival-without-arthroplasty point estimates were 89.8% (95% CI 86.5‒95.7%) and 84.9% (95% CI 75.1‒91.1%), respectively. The median 3-year estimated survival rate for the most recent study (n = 81) was 97.3%. The mean WOMAC Pain score decreased 71% from baseline to last follow-up after ISA implantation, from 58 ± 13 to 16 ± 17 points (p < 0.0001). The Function score improved 69%, decreasing from 56 ± 18 to 17 ± 17 points (p < 0.0001).
In younger patients with mild-to-moderate symptomatic medial compartment knee OA, implantation of the ISA device resulted in a 5-year survival rate of 85% from undergoing arthroplasty or HTO. The ISA system may be an effective treatment option for working-age patients with medial knee OA who are not candidates for or do not desire more invasive surgical approaches.
II. PurposeTo evaluate the 5-year rate of survival without undergoing arthroplasty or high tibial osteotomy (HTO) in subjects with mild-to-moderate medial compartment knee osteoarthritis (OA) who were treated with an implantable shock absorber (ISA) system.MethodsThree prospective, sequential, multicenter, international, single-arm clinical trials were conducted comprising subjects who received an ISA for symptomatic medial knee OA after failing ≥ 6 months of conservative therapy. Study outcomes were analyzed cumulatively and by enrollment group when all subjects’ follow-up data exceeded the 2-year threshold after ISA implantation. Primary outcome was survival rate without conversion to arthroplasty/HTO. Secondary outcomes were changes in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain and function scores after ISA implantation.ResultsAll 171 enrolled subjects (age 51 ± 9 years, body-mass index 28.5 ± 3.5 kg/m2, 38% female; study knee Kellgren–Lawrence score 2.7 ± 0.9 points) were followed for a minimum of 2, and up to 5, years after device implantation. Overall, 90.6% (155/171) of subjects survived without requiring arthroplasty/HTO at last follow-up (mean 3.2 ± 1.6 years). The Kaplan–Meyer median 3- and 5-year survival-without-arthroplasty point estimates were 89.8% (95% CI 86.5‒95.7%) and 84.9% (95% CI 75.1‒91.1%), respectively. The median 3-year estimated survival rate for the most recent study (n = 81) was 97.3%. The mean WOMAC Pain score decreased 71% from baseline to last follow-up after ISA implantation, from 58 ± 13 to 16 ± 17 points (p < 0.0001). The Function score improved 69%, decreasing from 56 ± 18 to 17 ± 17 points (p < 0.0001).ConclusionsIn younger patients with mild-to-moderate symptomatic medial compartment knee OA, implantation of the ISA device resulted in a 5-year survival rate of 85% from undergoing arthroplasty or HTO. The ISA system may be an effective treatment option for working-age patients with medial knee OA who are not candidates for or do not desire more invasive surgical approaches.Level of evidenceII. To evaluate the 5-year rate of survival without undergoing arthroplasty or high tibial osteotomy (HTO) in subjects with mild-to-moderate medial compartment knee osteoarthritis (OA) who were treated with an implantable shock absorber (ISA) system.PURPOSETo evaluate the 5-year rate of survival without undergoing arthroplasty or high tibial osteotomy (HTO) in subjects with mild-to-moderate medial compartment knee osteoarthritis (OA) who were treated with an implantable shock absorber (ISA) system.Three prospective, sequential, multicenter, international, single-arm clinical trials were conducted comprising subjects who received an ISA for symptomatic medial knee OA after failing ≥ 6 months of conservative therapy. Study outcomes were analyzed cumulatively and by enrollment group when all subjects' follow-up data exceeded the 2-year threshold after ISA implantation. Primary outcome was survival rate without conversion to arthroplasty/HTO. Secondary outcomes were changes in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain and function scores after ISA implantation.METHODSThree prospective, sequential, multicenter, international, single-arm clinical trials were conducted comprising subjects who received an ISA for symptomatic medial knee OA after failing ≥ 6 months of conservative therapy. Study outcomes were analyzed cumulatively and by enrollment group when all subjects' follow-up data exceeded the 2-year threshold after ISA implantation. Primary outcome was survival rate without conversion to arthroplasty/HTO. Secondary outcomes were changes in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain and function scores after ISA implantation.All 171 enrolled subjects (age 51 ± 9 years, body-mass index 28.5 ± 3.5 kg/m2, 38% female; study knee Kellgren-Lawrence score 2.7 ± 0.9 points) were followed for a minimum of 2, and up to 5, years after device implantation. Overall, 90.6% (155/171) of subjects survived without requiring arthroplasty/HTO at last follow-up (mean 3.2 ± 1.6 years). The Kaplan-Meyer median 3- and 5-year survival-without-arthroplasty point estimates were 89.8% (95% CI 86.5‒95.7%) and 84.9% (95% CI 75.1‒91.1%), respectively. The median 3-year estimated survival rate for the most recent study (n = 81) was 97.3%. The mean WOMAC Pain score decreased 71% from baseline to last follow-up after ISA implantation, from 58 ± 13 to 16 ± 17 points (p < 0.0001). The Function score improved 69%, decreasing from 56 ± 18 to 17 ± 17 points (p < 0.0001).RESULTSAll 171 enrolled subjects (age 51 ± 9 years, body-mass index 28.5 ± 3.5 kg/m2, 38% female; study knee Kellgren-Lawrence score 2.7 ± 0.9 points) were followed for a minimum of 2, and up to 5, years after device implantation. Overall, 90.6% (155/171) of subjects survived without requiring arthroplasty/HTO at last follow-up (mean 3.2 ± 1.6 years). The Kaplan-Meyer median 3- and 5-year survival-without-arthroplasty point estimates were 89.8% (95% CI 86.5‒95.7%) and 84.9% (95% CI 75.1‒91.1%), respectively. The median 3-year estimated survival rate for the most recent study (n = 81) was 97.3%. The mean WOMAC Pain score decreased 71% from baseline to last follow-up after ISA implantation, from 58 ± 13 to 16 ± 17 points (p < 0.0001). The Function score improved 69%, decreasing from 56 ± 18 to 17 ± 17 points (p < 0.0001).In younger patients with mild-to-moderate symptomatic medial compartment knee OA, implantation of the ISA device resulted in a 5-year survival rate of 85% from undergoing arthroplasty or HTO. The ISA system may be an effective treatment option for working-age patients with medial knee OA who are not candidates for or do not desire more invasive surgical approaches.CONCLUSIONSIn younger patients with mild-to-moderate symptomatic medial compartment knee OA, implantation of the ISA device resulted in a 5-year survival rate of 85% from undergoing arthroplasty or HTO. The ISA system may be an effective treatment option for working-age patients with medial knee OA who are not candidates for or do not desire more invasive surgical approaches.II.LEVEL OF EVIDENCEII. Purpose To evaluate the 5-year rate of survival without undergoing arthroplasty or high tibial osteotomy (HTO) in subjects with mild-to-moderate medial compartment knee osteoarthritis (OA) who were treated with an implantable shock absorber (ISA) system. Methods Three prospective, sequential, multicenter, international, single-arm clinical trials were conducted comprising subjects who received an ISA for symptomatic medial knee OA after failing ≥ 6 months of conservative therapy. Study outcomes were analyzed cumulatively and by enrollment group when all subjects’ follow-up data exceeded the 2-year threshold after ISA implantation. Primary outcome was survival rate without conversion to arthroplasty/HTO. Secondary outcomes were changes in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain and function scores after ISA implantation. Results All 171 enrolled subjects (age 51 ± 9 years, body-mass index 28.5 ± 3.5 kg/m 2 , 38% female; study knee Kellgren–Lawrence score 2.7 ± 0.9 points) were followed for a minimum of 2, and up to 5, years after device implantation. Overall, 90.6% (155/171) of subjects survived without requiring arthroplasty/HTO at last follow-up (mean 3.2 ± 1.6 years). The Kaplan–Meyer median 3- and 5-year survival-without-arthroplasty point estimates were 89.8% (95% CI 86.5‒95.7%) and 84.9% (95% CI 75.1‒91.1%), respectively. The median 3-year estimated survival rate for the most recent study ( n = 81) was 97.3%. The mean WOMAC Pain score decreased 71% from baseline to last follow-up after ISA implantation, from 58 ± 13 to 16 ± 17 points ( p < 0.0001). The Function score improved 69%, decreasing from 56 ± 18 to 17 ± 17 points ( p < 0.0001). Conclusions In younger patients with mild-to-moderate symptomatic medial compartment knee OA, implantation of the ISA device resulted in a 5-year survival rate of 85% from undergoing arthroplasty or HTO. The ISA system may be an effective treatment option for working-age patients with medial knee OA who are not candidates for or do not desire more invasive surgical approaches. Level of evidence II. |
Author | Flanigan, David C. Crawford, Dennis C. Ranawat, Anil S. Walawski, Jacek Slynarski, Konrad Gomoll, Andreas H. Diduch, David R. |
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BackLink | https://www.ncbi.nlm.nih.gov/pubmed/36951981$$D View this record in MEDLINE/PubMed |
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CitedBy_id | crossref_primary_10_1016_j_arthro_2025_01_058 crossref_primary_10_1016_j_injury_2025_112291 crossref_primary_10_1016_j_eats_2024_103162 |
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Copyright | The Author(s) under exclusive licence to European Society of Sports Traumatology, Knee Surgery, Arthroscopy (ESSKA) 2023. Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law. 2023. The Author(s) under exclusive licence to European Society of Sports Traumatology, Knee Surgery, Arthroscopy (ESSKA). |
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Keywords | Total knee arthroplasty Survivorship WOMAC pain and function score Implantable shock absorber Functional outcomes Medial compartment knee osteoarthritis |
Language | English |
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To evaluate the 5-year rate of survival without undergoing arthroplasty or high tibial osteotomy (HTO) in subjects with mild-to-moderate medial... To evaluate the 5-year rate of survival without undergoing arthroplasty or high tibial osteotomy (HTO) in subjects with mild-to-moderate medial compartment... PurposeTo evaluate the 5-year rate of survival without undergoing arthroplasty or high tibial osteotomy (HTO) in subjects with mild-to-moderate medial... |
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SubjectTerms | Age Arthritis Arthroplasty Clinical trials Implantation Joint surgery Knee Medicine Medicine & Public Health Orthopedics Osteoarthritis Osteotomy Pain Patients Shock absorbers Sports Medicine Survival Transplants & implants |
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Title | An implantable shock absorber yields an 85% survival-from-arthroplasty rate through 5 years in working-age patients with medial compartment knee osteoarthritis |
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