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RSA vs. Nonop for 3 & 4-Part Proximal Humerus Fractures

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ClinicalTrials.gov Identifier: NCT03599336
Recruitment Status : Terminated (Slower than expected enrollment.)
First Posted : July 26, 2018
Last Update Posted : October 11, 2021
Sponsor:
Information provided by (Responsible Party):
Jonathan D. Barlow, Mayo Clinic

Brief Summary:
There is currently no consensus amongst orthopedic specialists on the best way to treat 3- and 4-part proximal humerus fractures. No surgery and surgery with a type of shoulder replacement called a reverse total shoulder arthroplasty are two options that many orthopedists use. This study is being performed to evaluate the differences in short- and long-term pain and functional outcomes between patients who are treated with these two different options.

Condition or disease Intervention/treatment Phase
Humerus Fracture Humerus Shoulder Fractures Shoulder Arthropathy Associated With Other Conditions Arthropathy Shoulder Shoulder Injury Arthropathy Procedure: Reverse Total Shoulder Arthroplasty (rTSA) Other: Nonoperative Treatment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Reverse Total Shoulder Arthroplasty Versus Nonoperative Treatment of 3 & 4-Part Proximal Humerus Fractures
Actual Study Start Date : August 1, 2018
Actual Primary Completion Date : October 29, 2020
Actual Study Completion Date : October 29, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Nonoperative Treatment
Subjects will have nonoperative treatment to treat proximal humerus fracture that is broken into 3 or 4 parts.
Other: Nonoperative Treatment
Subjects allocated to the nonoperative treatment arm will maintain sling immobilization for 3 weeks. The sling will be removed for elbow, wrist and hand range of motion (ROM), hygiene, and dressing only. At 3 weeks passive ROM in external rotation (ER) and forward elevation (FE) will be added. At 6 weeks from injury, the sling will be removed and stretching in all planes will be allowed. Use of the arm will be up to a fork/knife/toothbrush only. At 3 months from injury, strengthening will be added. Supervised physical therapy will be offered to patients for use at their discretion, as is current practice.

Operative Course for rTSA
Subjects will have shoulder replacement surgery to treat proximal humerus fracture that is broken into 3 or 4 parts.
Procedure: Reverse Total Shoulder Arthroplasty (rTSA)
Surgical management will include placement of fracture specific, cemented reverse total shoulder arthroplasty components as per standard surgical care and routine postoperative rehabilitation.




Primary Outcome Measures :
  1. Function as described by ASES score at 1 year follow-up. [ Time Frame: 2 year follow-up ]
    The American Shoulder and Elbow Surgeons (ASES) score is a well-validated, patient-reported outcome measure used by shoulder and elbow surgeons. The score ranges from 0-100 with 100 signifying the best outcome. Half of the score correlates to pain and half to function, both on a 0-50 scale where higher is again considered a better outcome. The pain portion is tabulated by taking the patient's response on a visual analogue scale (0 to 10 scale where 0 represent no pain and 10 represents worst pain imaginable), subtracting it from 10, and then multiplying by 5. The function score is tabulated by taking the patient's response on 10 questions rated on an ordinal scale from 0-3 and then multiplying the cumulative score by 5/3.



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  • Displaced 3- and 4-part proximal humerus fractures.
  • Age greater than or equal to 65 years old.

Exclusion Criteria

  • Less than 65 years old.
  • Medical comorbidities precluding surgical treatment or anesthesia
  • Dementia or inability to provide adequate follow up.
  • Pathologic fractures
  • Open fractures
  • Associated injuries: fracture dislocations, multiple or complex injuries of the ipsilateral limb, complete brachial plexopathy, vascular injury and polytrauma.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03599336


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Jonathan D Barlow Mayo Clinic
Additional Information:
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Responsible Party: Jonathan D. Barlow, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03599336    
Other Study ID Numbers: 18-002097
First Posted: July 26, 2018    Key Record Dates
Last Update Posted: October 11, 2021
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Joint Diseases
Fractures, Bone
Humeral Fractures
Shoulder Injuries
Shoulder Fractures
Wounds and Injuries
Musculoskeletal Diseases
Arm Injuries