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Two-Year Results of the PHANTOM High Flex Trial: A Single-Arm Study on the Atlas Unicompartmental Knee System Load Absorber in Patients With Medial Compartment Osteoarthritis of the Knee.

ABSTRACT: The Atlas Knee System was designed to fill the gap between no longer effective conservative treatments and more invasive surgery for young patients with medial knee osteoarthritis (OA). This article reports on the 2-year results of a single-arm study of 26 subjects who previously reported favorable clinical outcomes 1?year post implantation. Western Ontario and McMaster Universities Osteoarthritis Index pain and function scores improved by a clinically meaningful amount relative to baseline, and subjects had a return to normal range of motion. This study confirmed that the benefit of a joint unloading device in the management of young patients with medial knee OA is maintained over 2?years. This trial was registered with ClinicalTrials.gov (NCT02711254).

SUBMITTER: Slynarski K

PROVIDER: S-EPMC6757501 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Two-Year Results of the PHANTOM High Flex Trial: A Single-Arm Study on the Atlas Unicompartmental Knee System Load Absorber in Patients With Medial Compartment Osteoarthritis of the Knee.

Slynarski Konrad K Walawski Jacek J Smigielski Robert R van der Merwe Willem W

Clinical medicine insights. Arthritis and musculoskeletal disorders 20190923

The Atlas Knee System was designed to fill the gap between no longer effective conservative treatments and more invasive surgery for young patients with medial knee osteoarthritis (OA). This article reports on the 2-year results of a single-arm study of 26 subjects who previously reported favorable clinical outcomes 1 year post implantation. Western Ontario and McMaster Universities Osteoarthritis Index pain and function scores improved by a clinically meaningful amount relative to baseline, and ...[more]

PMID: 31579106

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Project description:BackgroundThere remains a paucity of clinical studies assessing how any differences in accuracy of implant positioning between robotic-arm assisted unicompartmental knee arthroplasty (RO UKA) and conventional jig-based unicompartmental knee arthroplasty (CO UKA) translate to patient satisfaction, functional outcomes, and implant survivorship. The objectives of this study are to compare accuracy of implant positioning, limb alignment, patient satisfaction, functional outcomes, implant survivorship, cost-effectiveness, and complications in CO UKA versus RO UKA. Computer navigation will be used to assess intraoperative knee kinematics in all patients undergoing CO UKA.Methods and analysisThis prospective randomised controlled trial will include 140 patients with symptomatic medial compartment knee arthritis undergoing primary UKA. Following informed consent, patients will be randomised to CO UKA (control group) or RO UKA (investigation group) at a ratio of 1:1 using an online random number generator. The primary objective of this study is to compare accuracy of implant positioning in CO UKA versus RO UKA. The secondary objectives are to compare the following outcomes between the two treatment groups: limb alignment, surgical efficiency, postoperative functional rehabilitation, functional outcomes, quality of life, range of motion, resource use, cost effectivness, and complications. Observers will review patients at regular intervals for 2 years after surgery to record predefined study outcomes pertaining to these objectives. Ethical approval was obtained from the London-Bloomsbury Research Ethics Committee, UK. The study is sponsored by University College London, UK.DiscussionThis study compares a comprehensive and robust range of clinical, functional, and radiological outcomes in CO UKA versus RO UKA. The findings of this study will provide an improved understanding of the differences in CO UKA versus RO UKA with respect to accuracy of implant positioning, patient satisfaction, functional outcomes, implant survivorship, cost-effectiveness, and complications.Trial registrationClinicalTrials.gov NCT04095637 . Registered on 19 September 2019.

Project description:PurposeTo quantify intraoperative joint space widening afforded by the outside-in, percutaneous release of the medial collateral ligament (MCL) and to evaluate its impact on medial compartment width and functional outcomes at 6-week follow-up for patients undergoing a partial medial meniscectomy without postoperative bracing.MethodsPatients with posteromedial meniscus tears and no evidence of ipsilateral knee pathology, undergoing partial medial meniscectomy, were enrolled. Intraoperatively, medial compartment width was quantified with fluoroscopy before and after the percutaneous MCL release with an 18-gauge spinal needle proximal to the joint line. At 6-week follow-up, valgus stress radiographs re-evaluated medial compartment width. International Knee Documentation Committee (IKDC) and Patient-Reported Outcomes Measurement Information System (PROMIS) scores were completed preoperatively and at 6-week follow-up to evaluate functional outcomes. A paired sample t test performed at a 95% confidence interval (CI) was used to compare these variables.ResultsForty-two patients, mean (± standard deviation) age 55.3 ± 10.7 years, were available for analysis of intraoperative medial compartment widening. Medial compartment width increased from 5.95 ± 1.32 to 11.09 ± 1.74 mm intraoperatively after MCL release. At 6-week follow-up, radiographic assessment demonstrated a mean medial compartment width of 5.85 ± .99 mm, which represented an insignificant change compared with the preoperative value (CI -0.68 to .33, P = .474). PROMIS and IKDC scores significantly improved from baseline, with increases of 6.9 ± 12.4 (CI 2.0 to 11.8, P = .008) and 11.7 ± 17.8 (CI 4.7 to 18.8, P = .002), respectively.ConclusionsPercutaneous MCL release during knee arthroscopy improves visualization and facilitates instrumentation by providing an almost 2× wider working space within the medial tibiofemoral joint. In this study, the performance of percutaneous MCL release did not result in any complications. Radiographic and clinical resolution of iatrogenic laxity was demonstrated by 6-weeks postoperatively, without the use of postoperative bracing.Level of evidenceIV, therapeutic case series.

Dataset Information

Two-Year Results of the PHANTOM High Flex Trial: A Single-Arm Study on the Atlas Unicompartmental Knee System Load Absorber in Patients With Medial Compartment Osteoarthritis of the Knee.

Publications

Two-Year Results of the PHANTOM High Flex Trial: A Single-Arm Study on the Atlas Unicompartmental Knee System Load Absorber in Patients With Medial Compartment Osteoarthritis of the Knee.

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