GLOBAL ICON Stemless Shoulder System Post Market Clinical Follow Up Study

DePuy Orthopaedics171 enrolled

Overview

This is a Post Market Clinical Follow Up (PMCF) study to monitor the safety and performance of the GLOBAL ICON stemless humeral component. The data gathered will be used to support post market surveillance of the device, and may potentially be used for additional market access purposes.

This study will be multi-centre and non-comparative. Subjects will be recruited and followed up at similar intervals to reflect the standard clinical practice and intended population for wider use of the device. 157 non-randomised subjects will be recruited from approximately 15 sites. A maximum of 30 subjects may be recruited from one site. More than one implanting surgeon may recruit subjects at each site as a designated sub-Investigator. The primary objective of this PMCF study is to confirm device survivorship of the GLOBAL ICON stemless humeral component at 24 months post-operative. The secondary objectives include the evaluation of clinical performance, radiographic performance and safety outcomes at 3, 12, 24, 60 and 120 months post-operatively. Tertiary endpoints in the study will include a mean change from baseline for the Adjusted Constant-Murley Score, the Oxford Shoulder Score, the EQ-5D-5L dimension score and EQ-VAS scores. Radiographic evidence of aseptic loosening and periprosthetic fracture survivorship of the GLOBAL ICON stemless humeral component will be assessed.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

171

Conditions

Osteoarthritis Post Traumatic Arthritis

Interventions

Global ICONDEVICE

The study device is the GLOBAL ICON stemless humeral component, consisting of the Anchor Plate and Humeral Head.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 79 Years

Medical Language ↔ Plain English

Inclusion Criteria: Severely painful and/or severely disabled Non-Inflammatory Degenerative Joint Disease (NIDJD) resulting from osteoarthritis (OA) or post traumatic arthritis Patient is willing and able to complete the required post-operative schedule Patient has provided written Informed Consent to participate Exclusion Criteria: Subjects under the age of 21 or over the age of 80 on the day of consent Subjects who have not reached skeletal maturity, regardless of age Inadequate bone stock in the proximal humerus or glenoid fossa for supporting the GLOBAL ICON stemless humeral components Bone that is too soft or porous to support the implant or that is too hard or brittle to allow for proper bone preparation and fixation, i.e osteoporosis or sclerotic bone, where there could be considerable migration of the prosthesis and/or a chance of fracture of the humerus or glenoid Fractures of the proximal humerus that could compromise the fixation of the GLOBAL ICON stemless humeral components Subjects who have undergone previous treatment on the study shoulder that may compromise fixation of the GLOBAL ICON stemless humeral components Revision of a failed hemi, total or reverse shoulder arthroplasty Active local or systemic infection Absent, irreparable or nonfunctional rotator cuff or other essential muscles Subject is receiving, or is scheduled to receive, treatment that the Investigator considers could affect bone quality, such as chemotherapy or high dose corticosteroids Subjects who, at the point of enrolment, already have a GLOBAL ICON shoulder replacement or are scheduled to receive, a contralateral shoulder replacement device Subjects who are known to be pregnant or breastfeeding Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes Subjects with a known medical condition that the Investigator believes would impact the study outcomes (including, but not limited to osteomyelitis, Paget's disease, neuropathies such as Charcot's disease, metastatic or neoplastic disorders) Known polyethylene and/or metal sensitivity or allergy

Locations (12)

Kingston General Hospital

Kingston, Canada

Vulpius Klinik

Bad Rappenau, Germany

Orthopädische Klinik der Medizinischen Hochschule Hannover im Diakovere Annastift

Hanover, Germany

Outcomes

Primary Outcomes

Percentage of Participants With Overall Composite Clinical Success

Percentage of participants with overall composite clinical success at 24 months was reported. Composite success was achieved if each of the following criteria was met: (1) Radiographs indicated that there was no continuous radiolucent line (RLL) around the GLOBAL ICON stemless humeral component, with continuous RLL defined as a radiolucent line greater than (\>) 1millimeter (mm) in all five zones of either anterior-posterior (AP) or Axillary views (2) The adjusted Constant-Murley score was greater than 85, with the adjustment based on the method of Constant (3) No GLOBAL ICON humeral component was removed for any reason (4) There was no device-related serious adverse events.

Time frame: At 24 months

Adjusted Constant-Murley Shoulder Assessment Score

Constant-Murley Score on operative shoulder adjusted for gender and age. Please note that scores are adjusted to reflect gender and age of participants. The Constant-Murley score is divided into four subscales, including pain (15 points maximum), activities of daily living (20 points maximum), ROM (40 points maximum), and strength (25 points maximum). The higher the score, the higher the quality of function (minimum 0, maximum 100) Adjustment may lead to scores above 100 depending on age of group analyzed. The range for the Adjusted Constant-Murley score in a male participant is 0-178.6; the range for the Adjusted Constant-Murley score in a female participant is 0-192.3. Please note the calculations of the maximum Adjusted score assume a perfect score (100) in 100 year old male and female participants.

Time frame: 24 Months

Continuous Radiolucent Line

X-rays are reviewed by an independent radiographic reviewer to determine if a 1 mm wide or greater, continuous radiolucent line around the entire bony border of the GLOBAL ICON Stemless Shoulder implant exists. Such a line may indicate the implant is loosening.

Time frame: 24 months

Kaplan Meier Survivorship

Kaplan Meier Survival Estimate is based upon the number of GLOBAL ICON implants remaining in the study and the number of GLOBAL ICON implants that have been revised (surgically removed from participants).

Data from ClinicalTrials.gov

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Secondary Outcomes

Mean Adjusted Constant-Murley Score at Baseline, 3, 12, 24, and 60 Months Post-operative

Constant-Murley Score was adjusted to reflect gender and age of participants. The Constant-Murley score was divided into four subscales, including pain (15 points maximum), activities of daily living (20 points maximum), ROM (40 points maximum), and strength (25 points maximum). The higher the score, the higher the quality of function (minimum 0, maximum 100). Adjustment may lead to scores above 100 depending on age of group analyzed. The range for the Adjusted Constant-Murley score in a male participant was 0-178.6; the range for the Adjusted Constant-Murley score in a female participant was 0-192.3. The calculations of the maximum Adjusted score assume a perfect score (100) in 100 year old male and female participants.

Time frame: At Baseline (Day 0), 3, 12, 24, and 60 months

Mean Oxford Shoulder Score at Baseline, 3, 12, 24, and 60 Months Post-operative

The Oxford Shoulder Score (OSS) was a patient-based questionnaire used to assess shoulder pain after surgery. It consisted of 12 questionnaire items with 5 ordinal response options for each question. Each response was scored from 0 to 4 points (4 = best/least problems and 0=worst/unbearable pain). All item scores across 12 questions were summed to produce a scale of 0-48 (where a higher score reflected best/least problems).

Time frame: At Baseline (Day 0), 3, 12, 24, and 60 months

Mean EuroQol-5 Dimension 5-Level (EQ-5D-5L) Scores by Dimensions at Baseline, 3, 12, 24, and 60 Months Post-operative

Mean EQ-5D-5L scores by dimensions at baseline, 3, 12, 24, and 60 months were reported. EQ-5D-5L consisted of the EQ-5D-5L descriptive system and the EQ Visual Analogue Scale (EQ-VAS). The EQ-5D-5L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The 5-item index score was transformed into a utility score between 0 (worst health state) and 1 (best health state). Higher score indicated good health. EQ-VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on a scale of 0 (worst health you can imagine) to 100 (best health you can imagine). Positive change in score indicated improvement.

Time frame: At Baseline (Day 0), 3, 12, 24, and 60 months

Mean Visual Analog Scale (EQ-VAS) Score at Baseline, 3, 12, 24, and 60 Months Post-operative

EQ-5D-5L consisted of the EQ-5D-5L descriptive system and the EQ-VAS. EQ-VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on a scale of 0 (worst health you can imagine) to 100 (best health you can imagine). Positive change in score indicated improvement.

Time frame: At Baseline (Day 0), 3, 12, 24, and 60 months

Number of Participants With Radiographic Evidence of Aseptic Loosening of the Global Icon Stemless Humeral Component Immediate Post-operative and 3, 12, 24, and 60 Months Post-operative

Number of participants with radiographic evidence of aseptic loosening of the global icon stemless humeral component immediate post-operative and 3, 12, 24 and 60 months post-operative were reported. Aseptic Loosening was evaluated using all available imaging. Progressing radiolucencies and/or stress shielding indicated aseptic loosening.

Time frame: Immediate post operative (0-10 Days), at 3, 12, 24, and 60 months