Clinical trial NCT04468178: Clinical Results and RSA Migration Analysis of the GLOBAL ICON - Stemless Anatomic Shoulder
Official title: Clinical Results and RSA Migration Analysis of the GLOBAL ICON - Stemless Anatomic Shoulder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteoarthritis of the Shoulder
Keywords: osteoarthritis
shoulder
joint replacement
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
First posted: 2020-07-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective, randomized controlled mono-centric study
Primary purpose: TREATMENT

Brief summary: The primary goal of the clinical trial is to determine that the GLOBAL ICON implant system from DePuy does not exhibit worse shoulder function after 2 years than the SIMPLICITY from Wright Medical. The primary endpoint is the Constant-Murley Shoulder Score (CMSS) of the implant after 2 years, the non-inferiority of which is to be demonstrated in comparison with an already established prosthetic system (SIMPLICITY, Wright Medical).

Detailed description: The primary goal of the clinical trial is to determine that the GLOBAL ICON implant system from DePuy does not exhibit worse shoulder function after 2 years than the SIMPLICITY from Wright Medical. The primary endpoint is the Constant-Murley Shoulder Score (CMSS) of the implant after 2 years, the non-inferiority of which is to be demonstrated in comparison with an already established prosthetic system (SIMPLICITY, Wright Medical).

As secondary endpoints, the migration behavior of the humeral components over time will be determined by radiostereometric analysis (RSA), the further clinical-functional results and the satisfaction of the patients treated will be investigated. Clinical outcomes are measured using standardized and reproducible clinical scores (Oxford Shoulder Score -OSS and Short Form Health 36-SF-36 v1.0 ) at each time of examination.

Other endpoints include revision rate within the follow-up period, surgical time (incision to suture), and delays in surgical procedures due to instrumentation.

The times of data acquisition are the admission day before the operation to determine the preoperative status, the discharge day and the follow-up appointments after 3 months, 6 months, 12 months and 24 months to determine the postoperative status and course.

Eligibility criteria: Inclusion Criteria:

1. Trial participants need primary total shoulder replacement due to primary osteoarthritis or post-traumatic osteoarthritis
2. Trial participants are willing to take part in the clinical trial and intend to be available for the planned follow-up examinations.
3. Male, female and various subjects with age on the day of surgery from 18 to 80 years inclusive.
4. Subjects agree not to participate in any other clinical trial for at least 2 years (+ 3 weeks) using the index procedure. This includes clinical trials of medication, invasive procedures and medical devices. Questionnaire-based studies or other studies that are non-invasive and do not involve drug use are allowed.
5. Exclusion of intraoperative circumstances that require the implantation of a prosthesis type other than that provided for in the clinical trial (depending on the surgeon).

Exclusion Criteria:

1. Previous operation on the rotator cuff of the affected shoulder
2. Dysfunctional rotator cuff
3. Infection of the affected shoulder joint or systemic infection
4. Pregnant or breastfeeding women and those who are planning to become pregnant for up to 2 years (+3 weeks) using the index procedure

Primary outcomes:
measure: Constant-Murley Score (CMS)
timeFrame: 3 months postoperative
measure: Constant-Murley Score (CMS)
timeFrame: 12 months postoperative
measure: Constant-Murley Score (CMS)
timeFrame: 24 months postoperative
Secondary outcomes:
measure: Oxford Shoulder Score (OSS)
timeFrame: 3 months postoperative
measure: Oxford Shoulder Score (OSS)
timeFrame: 12 months postoperative
measure: Oxford Shoulder Score (OSS)
timeFrame: 24 months postoperative
measure: Short Form Health 36 (SF-36)
timeFrame: 3 months postoperative
measure: Short Form Health 36 (SF-36)
timeFrame: 12 months postoperative
measure: Short Form Health 36 (SF-36)
timeFrame: 24 months postoperative
Other outcomes:
Locations:
city: Hanover
country: Germany
facility: Orthopädische Klinik der Medizinischen Hochschule Hannover im DIAKOVERE Annastift
state: Niedersachsen
Study officials:
affiliation: Orthopädische Klinik der Medizinischen Hochschule Hannover im DIAKOVERE Annastift
name: Tomas Smith, PD Dr.
role: PRINCIPAL_INVESTIGATOR
References: