The first-generation anatomical medial meniscus prosthesis led to unsatisfactory results: a first-in-human study

T G van Tienen; B van Minnen; K C Defoort; P J Emans; S A W van de Groes; N Verdonschot; L M Jutten; R W E Pikaart; P J C Heesterbeek

doi:10.1007/s00167-022-07205-x

The first-generation anatomical medial meniscus prosthesis led to unsatisfactory results: a first-in-human study

T G van Tienen^*, B van Minnen, K C Defoort, P J Emans, S A W van de Groes, N Verdonschot, L M Jutten, R W E Pikaart, P J C Heesterbeek

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

PURPOSE: The purpose of this first-in-human study was to evaluate the effect of a polycarbonate anatomical meniscus prosthesis system, including the surgical procedure, on knee pain and describe potential adverse events in patients with post-meniscectomy pain syndrome.

METHODS: Eleven patients with post-meniscectomy pain syndrome and limited underlying cartilage damage were enrolled in the study. Five received a medial polycarbonate urethane meniscus prosthesis which was clicked onto 2 titanium screws fixated at the native horn attachments on the tibia. The KOOS score was planned to be collected at baseline and at 3, 6, 12 and 24 months following the intervention including radiographs at 6, 12 and 24 months. MRI scans were repeated after 12 and 24 months.

RESULTS: The surgical technique to select an appropriately sized implant and correct positioning of the fixation screws and meniscus prosthesis onto the tibia was demonstrated to be feasible and reproducible. Inclusion stopped after 5 patients because of serious adverse device-related events. All patients reported knee joint stiffness and slight effusion in their knee at 6 months follow-up. In 3 patients the implant was removed because of implant failure and in 1 patient the implant was removed because of persistent pain and extension limitation. In none of the patients did the KOOS score improve in the first 6 months after surgery. However, in the patient who still has the implant in situ, PROMs started to improve 1 year after surgery and this improvement continued through 2 years of follow-up. The KOOS Pain, symptoms and ADL were close to the maximal 100 points. KOOS QoL and sport did improve but remained suboptimal.

CONCLUSION: This first version of the meniscus prosthesis led to impaired knee function and failed in four out of five patients. The patients where the prosthesis was removed were salvable and the PROMs returned to pre-study levels. The results in the patient where the device is still in place are promising.

LEVEL OF EVIDENCE: Level II.

Original language	English
Pages (from-to)	2526-2533
Number of pages	8
Journal	Knee Surgery Sports Traumatology Arthroscopy
Volume	31
Issue number	6
Early online date	7 Nov 2022
DOIs	https://doi.org/10.1007/s00167-022-07205-x
Publication status	Published - Jun 2023

Keywords

Artificial meniscus
Meniscectomy
Meniscus prosthesis
Meniscus replacement
Post-meniscectomy pain syndrome

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10.1007/s00167-022-07205-xLicence: CC BY

Cite this

van Tienen, T. G., van Minnen, B., Defoort, K. C., Emans, P. J., van de Groes, S. A. W., Verdonschot, N., Jutten, L. M., Pikaart, R. W. E., & Heesterbeek, P. J. C. (2023). The first-generation anatomical medial meniscus prosthesis led to unsatisfactory results: a first-in-human study. Knee Surgery Sports Traumatology Arthroscopy, 31(6), 2526-2533. https://doi.org/10.1007/s00167-022-07205-x

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title = "The first-generation anatomical medial meniscus prosthesis led to unsatisfactory results: a first-in-human study",

abstract = "PURPOSE: The purpose of this first-in-human study was to evaluate the effect of a polycarbonate anatomical meniscus prosthesis system, including the surgical procedure, on knee pain and describe potential adverse events in patients with post-meniscectomy pain syndrome.METHODS: Eleven patients with post-meniscectomy pain syndrome and limited underlying cartilage damage were enrolled in the study. Five received a medial polycarbonate urethane meniscus prosthesis which was clicked onto 2 titanium screws fixated at the native horn attachments on the tibia. The KOOS score was planned to be collected at baseline and at 3, 6, 12 and 24 months following the intervention including radiographs at 6, 12 and 24 months. MRI scans were repeated after 12 and 24 months.RESULTS: The surgical technique to select an appropriately sized implant and correct positioning of the fixation screws and meniscus prosthesis onto the tibia was demonstrated to be feasible and reproducible. Inclusion stopped after 5 patients because of serious adverse device-related events. All patients reported knee joint stiffness and slight effusion in their knee at 6 months follow-up. In 3 patients the implant was removed because of implant failure and in 1 patient the implant was removed because of persistent pain and extension limitation. In none of the patients did the KOOS score improve in the first 6 months after surgery. However, in the patient who still has the implant in situ, PROMs started to improve 1 year after surgery and this improvement continued through 2 years of follow-up. The KOOS Pain, symptoms and ADL were close to the maximal 100 points. KOOS QoL and sport did improve but remained suboptimal.CONCLUSION: This first version of the meniscus prosthesis led to impaired knee function and failed in four out of five patients. The patients where the prosthesis was removed were salvable and the PROMs returned to pre-study levels. The results in the patient where the device is still in place are promising.LEVEL OF EVIDENCE: Level II.",

keywords = "Artificial meniscus, Meniscectomy, Meniscus prosthesis, Meniscus replacement, Post-meniscectomy pain syndrome",

author = "{van Tienen}, {T G} and {van Minnen}, B and Defoort, {K C} and Emans, {P J} and {van de Groes}, {S A W} and N Verdonschot and Jutten, {L M} and Pikaart, {R W E} and Heesterbeek, {P J C}",

note = "{\textcopyright} 2022. The Author(s).",

year = "2023",

month = jun,

doi = "10.1007/s00167-022-07205-x",

language = "English",

volume = "31",

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journal = "Knee Surgery Sports Traumatology Arthroscopy",

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van Tienen, TG, van Minnen, B, Defoort, KC, Emans, PJ, van de Groes, SAW, Verdonschot, N, Jutten, LM, Pikaart, RWE & Heesterbeek, PJC 2023, 'The first-generation anatomical medial meniscus prosthesis led to unsatisfactory results: a first-in-human study', Knee Surgery Sports Traumatology Arthroscopy, vol. 31, no. 6, pp. 2526-2533. https://doi.org/10.1007/s00167-022-07205-x

TY - JOUR

T1 - The first-generation anatomical medial meniscus prosthesis led to unsatisfactory results

T2 - a first-in-human study

AU - van Tienen, T G

AU - van Minnen, B

AU - Defoort, K C

AU - Emans, P J

AU - van de Groes, S A W

AU - Verdonschot, N

AU - Jutten, L M

AU - Pikaart, R W E

AU - Heesterbeek, P J C

PY - 2023/6

Y1 - 2023/6

N2 - PURPOSE: The purpose of this first-in-human study was to evaluate the effect of a polycarbonate anatomical meniscus prosthesis system, including the surgical procedure, on knee pain and describe potential adverse events in patients with post-meniscectomy pain syndrome.METHODS: Eleven patients with post-meniscectomy pain syndrome and limited underlying cartilage damage were enrolled in the study. Five received a medial polycarbonate urethane meniscus prosthesis which was clicked onto 2 titanium screws fixated at the native horn attachments on the tibia. The KOOS score was planned to be collected at baseline and at 3, 6, 12 and 24 months following the intervention including radiographs at 6, 12 and 24 months. MRI scans were repeated after 12 and 24 months.RESULTS: The surgical technique to select an appropriately sized implant and correct positioning of the fixation screws and meniscus prosthesis onto the tibia was demonstrated to be feasible and reproducible. Inclusion stopped after 5 patients because of serious adverse device-related events. All patients reported knee joint stiffness and slight effusion in their knee at 6 months follow-up. In 3 patients the implant was removed because of implant failure and in 1 patient the implant was removed because of persistent pain and extension limitation. In none of the patients did the KOOS score improve in the first 6 months after surgery. However, in the patient who still has the implant in situ, PROMs started to improve 1 year after surgery and this improvement continued through 2 years of follow-up. The KOOS Pain, symptoms and ADL were close to the maximal 100 points. KOOS QoL and sport did improve but remained suboptimal.CONCLUSION: This first version of the meniscus prosthesis led to impaired knee function and failed in four out of five patients. The patients where the prosthesis was removed were salvable and the PROMs returned to pre-study levels. The results in the patient where the device is still in place are promising.LEVEL OF EVIDENCE: Level II.

AB - PURPOSE: The purpose of this first-in-human study was to evaluate the effect of a polycarbonate anatomical meniscus prosthesis system, including the surgical procedure, on knee pain and describe potential adverse events in patients with post-meniscectomy pain syndrome.METHODS: Eleven patients with post-meniscectomy pain syndrome and limited underlying cartilage damage were enrolled in the study. Five received a medial polycarbonate urethane meniscus prosthesis which was clicked onto 2 titanium screws fixated at the native horn attachments on the tibia. The KOOS score was planned to be collected at baseline and at 3, 6, 12 and 24 months following the intervention including radiographs at 6, 12 and 24 months. MRI scans were repeated after 12 and 24 months.RESULTS: The surgical technique to select an appropriately sized implant and correct positioning of the fixation screws and meniscus prosthesis onto the tibia was demonstrated to be feasible and reproducible. Inclusion stopped after 5 patients because of serious adverse device-related events. All patients reported knee joint stiffness and slight effusion in their knee at 6 months follow-up. In 3 patients the implant was removed because of implant failure and in 1 patient the implant was removed because of persistent pain and extension limitation. In none of the patients did the KOOS score improve in the first 6 months after surgery. However, in the patient who still has the implant in situ, PROMs started to improve 1 year after surgery and this improvement continued through 2 years of follow-up. The KOOS Pain, symptoms and ADL were close to the maximal 100 points. KOOS QoL and sport did improve but remained suboptimal.CONCLUSION: This first version of the meniscus prosthesis led to impaired knee function and failed in four out of five patients. The patients where the prosthesis was removed were salvable and the PROMs returned to pre-study levels. The results in the patient where the device is still in place are promising.LEVEL OF EVIDENCE: Level II.

KW - Artificial meniscus

KW - Meniscectomy

KW - Meniscus prosthesis

KW - Meniscus replacement

KW - Post-meniscectomy pain syndrome

U2 - 10.1007/s00167-022-07205-x

DO - 10.1007/s00167-022-07205-x

M3 - Article

C2 - 36336744

SN - 0942-2056

VL - 31

SP - 2526

EP - 2533

JO - Knee Surgery Sports Traumatology Arthroscopy

JF - Knee Surgery Sports Traumatology Arthroscopy

IS - 6

ER -