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Clinical Trial NCT06788717 for Shoulder Pain, Shoulder Injuries, Shoulder Fractures, Shoulder Disease, Shoulder Arthritis is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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MDR - Comprehensive Primary Revision Stems PMCF 59

Recruiting
Clinical Trial NCT06788717 is an observational study for Shoulder Pain, Shoulder Injuries, Shoulder Fractures, Shoulder Disease, Shoulder Arthritis that is recruiting. It started on 19 June 2025 with plans to enroll 59 participants. Led by Zimmer Biomet, it is expected to complete by 1 December 2040. The latest data from ClinicalTrials.gov was last updated on 11 July 2025.
Brief Summary
The objective of this retrospective and prospective consecutive series PMCF (Post Market Clinical Follow Up) study is to collect long-term data confirming safety, performance and clinical benefits of the Comprehensive Primary Revision Stems (implants and instrumentation) when used for shoulder arthroplasty at 1, 3, 5, 7 and 10 years.
Detailed Description
The safety of this device will be assessed by analyzing implant survivorship. This will be established by recording the incidence and frequency of revisions, complications, and adverse events. Relation of the events to implant, instrumentation and/or procedure should be specified.

The performance will be evaluated by assessment of reported clinical outcome measures (PROMs) as well as radiographic outcomes.

Official Title

Post-market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the Comprehensive® Primary Revision Stems (Implants and Instrumentation) - A Retrospective and Prospective Consecutive Series Study

Conditions
Shoulder PainShoulder InjuriesShoulder FracturesShoulder DiseaseShoulder Arthritis
Other Study IDs
  • MDRG2017-89MS-50E
NCT ID Number
NCT06788717
Start Date (Actual)
2025-06-19
Last Update Posted
2025-07-11
Completion Date (Estimated)
2040-12
Enrollment (Estimated)
59
Study Type
Observational
Status
Recruiting
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Treatment Group
The study population will comprise a consecutive cohort of 59 cases (males and females), implanted with the Comprehensive Primary Revision Stem.
Comprehensive Primary Revision Stems
Comprehensive Primary Revision Stem (implants and instrumentation) when used for shoulder arthroplasty.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Implant Survivorship at 10 years follow-up (Kaplan Meier)
Based on removal or intended removal of the device and determined using the Kaplan-Meier method.
10 years
Frequency and Incidence of Adverse Events (Safety)
Monitoring the frequency and incidence of adverse events, serious adverse events, adverse device effects, serious adverse device effects, and unanticipated serious adverse device effects as well as device deficiencies.
10 years
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Device Performance and Benefits evaluated through the Western Ontario Arthritis of the Shoulder (WOOS) outcome measure.
The secondary objective is the assessment of performance and clinical benefits by recording patient reported clinical outcome measures (PROMs), through the use of the Western Ontario Osteoarthritis of the Should Score (WOOS). The WOOS is a 19 item questionnaire. Patients rate their symptoms from no pain extreme pain. The total score is calculated where 0 is a normal healthy shoulder and 1900 is the worst possible result. WOOS% (% of raw score) can be calculated using the formula (1900 - the score)/19 and then 0% is the worst possible result and 100% is the best possible result.
10 years
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • Patient must be 18 years of age or older.
  • Patient must be willing and able to follow directions.
  • Study devices must have been implanted following the surgical technique and IFU for the Comprehensive Revision Stem

  • Off-label use.
  • Patient is a prisoner.
  • Patient is a current alcohol or drug abuser.
  • Patient has a psychiatric illness or cognitive deficit that will not allow for proper informed consent.
  • Patient is unwilling to sign informed consent.
  • Uncooperative patient or patient with neurologic disorders who are incapable of following directions.
Zimmer Biomet logoZimmer Biomet
Study Central Contact
Contact: Octavia Gladden, 7044930178, [email protected]
2 Study Locations in 2 Countries

California

Cedars Sinai Medical Center, Los Angeles, California, 900033, United States
Ali Zafar, Contact, [email protected]
John Itamura, MD, Principal Investigator
Recruiting
Aalborg University Hospital, Aalborg, DK-9000, Denmark
Julie Nicoux, Contact, +33 06 72 61 35 02, [email protected]
SteenLund Jensen, MD, Principal Investigator
Recruiting