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Enrolling by Invitation

NCT Number: NCT06788717

MDR - Comprehensive Primary Revision Stems PMCF

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.

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Key information

Conditions

Shoulder Pain Arthralgia Fractures, Bone Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Shoulder Arthritis Shoulder Disease Shoulder Fractures Shoulder Injuries Signs and Symptoms Wounds and Injuries

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Aalborg University Hospital, Aalborg, Denmark

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Comprehensive Primary Revision Stems

Device

Comprehensive Primary Revision Stem (implants and instrumentation) when used for shoulder arthroplasty.

Primary outcomes

  1. Implant Survivorship at 10 years follow-up (Kaplan Meier)

    Time frame: 10 years

    Based on removal or intended removal of the device and determined using the Kaplan-Meier method.

  2. Frequency and Incidence of Adverse Events (Safety)

    Time frame: 10 years

    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.

Secondary outcomes

  1. Device Performance and Benefits evaluated through the Western Ontario Arthritis of the Shoulder (WOOS) outcome measure.

    Time frame: 10 years

    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.

Sponsors and collaborators

Lead sponsor

Zimmer Biomet

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2035
Study completion
2040
First posted
Jan 23, 2025
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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