Exactech Humeral Reconstruction Prosthesis of Shoulder Arthroplasty PMCF (HRP)

Exactech Humeral Reconstruction Prosthesis of Shoulder Arthroplasty PMCF (HRP)
warning The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT05615246
Recruitment Status : **RECRUITING NOW**

First Posted : November 14, 2022

Last Update Posted : November 14, 2022

Sponsor:

Information provided by (Responsible Party):

Exactech

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Brief Summary:

The objective of this study is to collect and evaluate long-term clinical outcomes data in order to better understand the safety and performance of the Equinoxe Humeral Reconstruction Prosthesis in shoulder arthroplasty over time. This study will follow subjects for a period of up to 10 years post-surgery.

Osteoarthritis Shoulder Rheumatoid Arthritis Oncology

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: An Open Label, Multi-Center, Retrospective and Prospective Evaluation of Exactech Humeral Reconstruction Prosthesis of Shoulder Arthroplasty
Actual Study Start Date : September 5, 2018
Estimated Primary Completion Date : December 31, 2030
Estimated Study Completion Date : September 30, 2031
Resource links provided by the National Library of Medicine NIH NLM ABRV BLK 4

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Primary Outcome Measures :

  1. SST-12 [ Time Frame: Through study completion, an average of 1 per year ]

    Shoulder Simple Test (SST) – 12 questions with yes/no responses that measure shoulder pain and function from a patient’s perspective – 12 yes corresponds to 100%

  2. SPADI [ Time Frame: Through study completion, an average of 1 per year ]

    Shoulder Pain and Disability Index (SPADI) -13 questions assessing about pain scale (5 questions) and disability scale (8 questions) where 0 indicates no pain/no difficulty and 10 indicates worst pain imaginable/so difficult it requires help while performin these activities

  3. Constant [ Time Frame: Through study completion, an average of 1 per year ]

    Constant Shoulder Score – 100 points scale about pain, Activities of daily living, Strength test, and Range of Motions questions about shoulder where 100 % corresponds to the highest pain

  4. ASES [ Time Frame: Through study completion, an average of 1 per year ]

    American Shoulder and Elbow Surgeons Score (ASES) – 100 points scale about shoulder pain and performance evaluation in activities of daily living where 100 indicates the best shoulder condition

  5. UCLA [ Time Frame: Through study completion, an average of 1 per year ]

    University of California Los Angeles Shoulder Score (UCLA) – 5 Items score which combines both physician (3 items) and patient assessment (2 items) whith a total range from 0-35 where 0 indicates worse shoulder function and 35 better shoulder function outcomes

  6. TESS [ Time Frame: Through study completion, an average of 1 per year ]

    Toronto Extremity Salvage Score (TESS) – Patient functional assessment following for surgery for musculoskeletal tumors (Humeral Reconstruction Stem only) – 100-point score where higher score indicates a better outcome

  7. MSTS [ Time Frame: Through study completion, an average of 1 per year ]

    Musculoskeletal Tumor Society (MSTS) – 30 points [6 times (range 0-5)], simple measure of the upper extremity function (Humeral Reconstruction Stem only) – The maximum corresponds to the best score

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Information from the National Library of Medicine NIH NLM ABRV BLK 4

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
  • Patients who meet eligibility criteria
  • Patients who consent to participate to return for follow-up visits out to 10 years or longer

Inclusion Criteria:

  • Patient is indicated for shoulder arthroplasty (or has previously undergone shoulder arthroplasty)
  • Patient is at least 21 years of age
  • Patient is expected to survive at least 2 years beyond surgery
  • Patient is willing to participate by complying with pre- and postoperative visit requirements
  • Patient is willing and able to read and sign a study informed consent form

Exclusion Criteria:

  • Osteomyelitis of the proximal humerus or scapula; if a systemic infection or a secondary remote infection is suspected or confirmed, implentation should be delayed until infection is resolved
  • Inadequate or malformed bone that precludes adequate support or fixation of the prosthesis
  • Neuromuscular disorders that do not allow control of the joint
  • SIgnigicant injury to the brachial plexus
  • Non-functional deltoid muscles
  • Patient’s age, weight, or activity level would cause the surgeon to expect early failure of the system
  • The patient is unwilling or unable to comply with the post-operative care instructions
  • Alcohol, drug, or other subtance abuse
  • Any disease state that could adversely affect the function or longevity of the implant
  • Patient is pregnant
  • Patient is a prisoner
  • Patient has a physical or mental condition that would invalidate the results

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Responsible Party: Exactech
ClinicalTrials.gov Identifier: NCT05615246    
Other Study ID Numbers: CR18-001
First Posted: November 14, 2022    Key Record Dates
Last Update Posted: November 14, 2022
Last Verified: September 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

Source: View full study details on ClinicalTrials.gov

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

November 15, 2022Comments OffClinicalTrials.gov | Oncology Clinical Trials | Oncology Studies | US National Library of Medicine
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