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| ID | Type | Description | Link |
|---|---|---|---|
| R01AR062066-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NIH |
| National Institute on Aging (NIA) | NIH |
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In the United States, over 300,000 individuals over age 65 suffer from distal radius fractures (DRFs) each year. Despite the frequency of this injury and over 200 years of experience treating DRFs, management of elderly DRFs is still controversial. Close reduction and casting is a nonsurgical technique that is frequently used, but osteoporotic fractures, common in the elderly, often collapse and displace. The three currently applied surgical techniques are close reduction and percutaneous pinning, external fixation with or without percutaneous pinning, and internal fixation with volar locking plating. Preliminary evidence indicates that locking plate fixation can permit elderly patients to move their hands and wrists much sooner in order to return to self-care activities more quickly. Although these outcomes are promising, there is no randomized controlled clinical trial to demonstrate that the more invasive, and perhaps more costly, plating technique is superior to the other simpler approaches.
The specific aim of this 24-center randomized controlled trial is to compare outcomes of these three surgical techniques in treating unstable DRFs in the elderly. The secondary aim is to follow a cohort of elderly patients who choose not to have surgery to evaluate outcomes following treatment by close reduction and casting alone. This clinical trial is the most ambitious study in hand surgery by assembling most of the leading centers in North America to collect evidence-based data to guide future treatment of this prevalent injury in the growing elderly population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Internal Fixation | Experimental | Open Reduction and Internal Fixation: Internal fixation with a volar locking plating system |
|
| External Fixation | Experimental | External Fixation with a bridging external fixator. Can be done with or without percutaneous pinning. |
|
| Pinning | Experimental | Percutaneous pinning with any number of Kirschner wires |
|
| No Surgery | Active Comparator | Closed Reduction and casting: Closed reduction and immobilization with a cast and/or splint |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Open Reduction and Internal Fixation | Procedure | Internal fixation with a volar locking plating system |
|
| Measure | Description | Time Frame |
|---|---|---|
| Michigan Hand Outcomes Questionnaire score | upper-extremity questionnaire | 12months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Rapid Assessment of Physical Activity score | questionnaire | pre-injury and 24months |
| SF-36 score | QOL questionnaire | 12months |
| Measure | Description | Time Frame |
|---|---|---|
| Participant Demographics | Participant age, income, education level, race/ethnicity | baseline |
| Comorbidities | Self-Administered Comorbidity Checklist |
Inclusion Criteria:
Patients who have an unstable DRF for which surgical fixation is indicated
o AO type A2, A3, C1, C2
At least one of the following radiographic criteria indicating fracture instability
Patients with the ability to read and understand English (to complete study questionnaires)
Community-dwelling patients
Patients 60 years of age or older
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin C Chung, MD, MS | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Connecticut | Farmington | Connecticut | 06030 | United States | ||
| Norton Healthcare |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20375760 | Background | Chung KC, Song JW; WRIST Study Group. A guide to organizing a multicenter clinical trial. Plast Reconstr Surg. 2010 Aug;126(2):515-523. doi: 10.1097/PRS.0b013e3181df64fa. | |
| 23608306 | Background | Wrist and Radius Injury Surgical Trial (WRIST) Study Group. Reflections 1 year into the 21-Center National Institutes of Health--funded WRIST study: a primer on conducting a multicenter clinical trial. J Hand Surg Am. 2013 Jun;38(6):1194-201. doi: 10.1016/j.jhsa.2013.02.027. Epub 2013 Apr 20. |
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| External Fixation | Procedure | External Fixation with a bridging external fixator. Can be done with or without percutaneous pinning. |
|
| Percutaneous Pinning | Procedure | Pinning with any number of Kirschner wires |
|
| Closed Reduction and casting | Procedure | Closed reduction and immobilization with a cast and/or splint |
|
| complications | Complication Checklist for Distal Radius Fracture | 12months |
| Hand function | grip strength, lateral pinch strength, wrist motion | 12months |
| baseline |
| Therapy compliance | count of therapy sessions and description of therapy type | 12months |
| Louisville |
| Kentucky |
| 40241 |
| United States |
| Johns Hopkins University | Baltimore | Maryland | 21218 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 20114 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| HealthPartners Institute for Education and Research | Saint Paul | Minnesota | 55101 | United States |
| North Shore - Long Island Jewish Health System | Great Neck | New York | 11021 | United States |
| University of Rochester | Rochester | New York | 14642 | United States |
| OrthoCarolina | Charlotte | North Carolina | 28207 | United States |
| Duke University | Durham | North Carolina | 27710 | United States |
| Wake Forest University | Winston-Salem | North Carolina | 27157 | United States |
| Kettering Health Network | Centerville | Ohio | 45459 | United States |
| The MetroHealth System | Cleveland | Ohio | 44109 | United States |
| University of Oklahoma | Oklahoma City | Oklahoma | 73126 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| University of Washington | Seattle | Washington | 98104 | United States |
| Fraser Health Authority | New Westminster | British Columbia | V3L 3W7 | Canada |
| University of Manitoba | Winnipeg | Manitoba | Canada |
| University of Western Ontario | London | Ontario | N6A 4V2 | Canada |
| National University of Singapore | Singapore | Singapore |
| 36780156 | Derived | Jayaram M, Wu H, Yoon AP, Kane RL, Wang L, Chung KC. Comparison of Distal Radius Fracture Outcomes in Older Adults Stratified by Chronologic vs Physiologic Age Managed With Casting vs Surgery. JAMA Netw Open. 2023 Feb 1;6(2):e2255786. doi: 10.1001/jamanetworkopen.2022.55786. |
| 34142664 | Derived | Yoon AP, Wang Y, Wang L, Chung KC; and the WRIST Group. What Are the Tradeoffs in Outcomes after Casting Versus Surgery for Closed Extraarticular Distal Radius Fractures in Older Patients? A Statistical Learning Model. Clin Orthop Relat Res. 2021 Dec 1;479(12):2691-2700. doi: 10.1097/CORR.0000000000001865. |
| 34137830 | Derived | Chung KC, Kim HM, Malay S, Shauver MJ; WRIST Group. Comparison of 24-Month Outcomes After Treatment for Distal Radius Fracture: The WRIST Randomized Clinical Trial. JAMA Netw Open. 2021 Jun 1;4(6):e2112710. doi: 10.1001/jamanetworkopen.2021.12710. |
| 33337492 | Derived | Yoon AP, Wang C, Speth KA, Wang L, Chung KC; WRIST Group. Modifiable Factors Associated With Chronic Pain 1 Year After Operative Management of Distal Radius Fractures: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2020 Dec 1;3(12):e2028929. doi: 10.1001/jamanetworkopen.2020.28929. |
| 32433648 | Derived | Hooper RC, Zhou N, Wang L, Shauver MJ, Chung KC; WRIST Group. Pre-injury activity predicts outcomes following distal radius fractures in patients age 60 and older. PLoS One. 2020 May 20;15(5):e0232684. doi: 10.1371/journal.pone.0232684. eCollection 2020. |
| 31951273 | Derived | Chung KC, Cho HE, Kim Y, Kim HM, Shauver MJ; WRIST Group. Assessment of Anatomic Restoration of Distal Radius Fractures Among Older Adults: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2020 Jan 3;3(1):e1919433. doi: 10.1001/jamanetworkopen.2019.19433. |
| 30657531 | Derived | Chung KC, Malay S, Shauver MJ, Kim HM; WRIST Group. Assessment of Distal Radius Fracture Complications Among Adults 60 Years or Older: A Secondary Analysis of the WRIST Randomized Clinical Trial. JAMA Netw Open. 2019 Jan 4;2(1):e187053. doi: 10.1001/jamanetworkopen.2018.7053. |
| 29952895 | Derived | Nasser JS, Huetteman HE, Shauver MJ, Chung KC. Older Patient Preferences for Internal Fixation after a Distal Radius Fracture: A Qualitative Study from the Wrist and Radius Injury Surgical Trial. Plast Reconstr Surg. 2018 Jul;142(1):34e-41e. doi: 10.1097/PRS.0000000000004454. |
| ID | Term |
|---|---|
| D000092503 | Wrist Fractures |
| ID | Term |
|---|---|
| D014954 | Wrist Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
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| ID | Term |
|---|---|
| D000070799 | Open Fracture Reduction |
| D005593 | Fracture Fixation, Internal |
| D016267 | External Fixators |
| ID | Term |
|---|---|
| D005592 | Fracture Fixation |
| D019637 | Orthopedic Procedures |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D009984 | Orthopedic Fixation Devices |
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
| D053831 | Surgical Fixation Devices |
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