Modifiable Factors Associated With Chronic Pain 1 Year After Operative Management of Distal Radius Fractures

Key Points Question What are modifiable preoperative factors associated with developing chronic pain after distal radius fracture surgery? Findings In this secondary analysis of a randomized clinical trial with 146 participants, each 10-point increase in preoperative pain score was associated with 17% increased odds of chronic pain, and a 1-week delay in surgical intervention was associated with more than triple the odds of experiencing chronic pain. Internal fixation was associated with decreased risk of chronic pain compared with external fixation or pinning. Meaning In this study, earlier time to surgery, adequate preoperative pain control, and internal fixation were associated with lower risk of chronic pain development among patients with distal radius fracture who were treated surgically.

The protocol, informed consent form(s), recruitment materials, and all participant materials will 123 be submitted to the Institutional Review Board (IRB) for review and approval. Approval of both 124 the protocol and the consent form must be obtained before any participant is enrolled. Any 125 amendment to the protocol will require review and approval by the IRB before the changes are 126 implemented to the study. In addition, all changes to the consent form will be IRB-approved; a 127 determination will be made regarding whether a new consent needs to be obtained from 128 participants who provided consent, using a previously approved consent form. The goal of this 24-center randomized controlled trial is to compare the physical, functional and quality of life outcomes of three different surgical methods for treating distal radius fractures in the elderly: close reduction and percutaneous pinning (CRPP), external fixation with or without percutaneous pinning (EFP) and internal fixation with volar locking plates. We will also follow a cohort of patients who opt for the non-surgical treatment, close reduction and casting, to examine and compare the same outcomes following non-surgical treatment.

Objectives:
Primary 24 hospitals or health systems in the US, Canada, and Singapore

Description of Study Intervention:
Participants will be randomized to receive open reduction and internal fixation with a volar locking plate, closed reduction and external fixation with a bridging external fixator device with or without supplemental k-wire fixation, or closed reduction and percutaneous pinning with k-wires. Participants in the observation arm with be treated with closed reduction and casting.    technique is a promising treatment, its outcomes, complication rate and cost have not been studied in a 289 larger cohort of subjects in a clinical trial design. This study will be the first of its kind to define the most 290 optimal treatment for elderly DRFs.

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For Aim 5, we will perform an economic analysis comparing the three treatment arms. Economic 293 analysis has become an important tool for determining which treatment strategy will provide the best 294 outcome for the cost. In the PI's systematic review of over 3,000 Hand Surgery outcomes studies during 295 the past 17 years, he found less than 1% of these publications were economic analysis studies. 43 When 296 considering that the main impetus of the outcomes movement is to improve the quality of health care at 297   We will try to avoid all risks associated with surgery by employing best practices regarding pre-384 operative risk screening, infection control, and all other aspects of the surgical process.

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All patients may encounter the risk of loss of privacy or confidentiality. This risk is RARE. All be stored on encrypted servers and accessed via password protected computers. Hard copies of 394 study documents will be kept in locked cabinets in locked offices.

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All patients may encounter the risk of inconvenience, which is RARE. We will try to avoid this by 397 delivering surveys to patient to complete in the exam room prior to seeing the surgeon whenever 398 possible. We will also perform functional testing in an efficient manner.

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Rationale: Internal fixation allows for earlier motion of the affected hand and wrist, which prevents 444 complications related to immobilization and potentially results in better functional outcomes.

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Hypothesis: Patients treated with VLPS will have better outcomes than those treated with CRP and EFP.

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Aim 2: To compare the recovery trend for elderly DRFs treated with VLPS with CRP and EFP.

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Rationale: The rate of recovery for these three treatment methods is unknown. Patients will be assessed 449 at 2 weeks, 6 weeks, 3 months, 6 months, 12 months and 24 months after surgical treatment to 450 determine which treatment method provides the most rapid recovery.

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Hypothesis: Patients treated with VLPS will have better outcomes at earlier times than those treated 452 with the more conservative techniques, and the better outcomes will persist at the 24-month period.

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Aim 3: To determine predictors of outcomes after surgical treatment of DRFs in the elderly.

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Rationale: Predictors of functional outcomes in the elderly have not been studied. We will evaluate 456 predictors of outcomes based on demographic characteristics, fracture patterns and treatment types. determines that surgical fixation will be necessary, the patient will be placed in a splint and an 539 appointment will be scheduled at the next hand surgery clinic per institutional standard practice. When 540 the patient is seen in the hand surgery clinic, either the hand surgeon or PA will confirm the patient's 541 eligibility for surgery and the study and will explain the study using the provided script (MOOP Section 542 G4  It is important to note that once a patient has been randomized they should be followed until they have 614 completed the 24-month follow-up visit or they withdraw their consent. This applies to all patients 615 including those that have a different procedure than the one to which they were randomized.   This study has a single informed consent form that describes both the screening and study procedures.

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The Research Coordinator at each site will explain the study, review study requirements and emphasize 735 the voluntary nature of participation to potential participants in detail. Additionally, the patient will also 736 be told, as stated in the informed consent document, that non-participation will not affect his/her 737 medical care in any way. The Research Coordinator will briefly detail the casting and other three 738 procedures, in plain language, and explain that the procedures may be equally affective at repairing 739 his/her distal radius fracture and that there is no "best" treatment. The Research Coordinator will 740 briefly explain the randomization process and follow-up measures. Finally, the Research Coordinator will 741 tell the patient that he/she will be compensated $20 per follow-up assessment he/she completes, for a 742 total of $140.

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A written comprehensive informed consent document will be used. Each institution will use its own

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In an effort to collected as much data as possible, participants who were enrolled in the study at the 833 time of their 24-month assessment and who did not complete the assessment will be contacted at the

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Rationale: The rate of recovery for these three treatment methods is unknown. Patients will be assessed 918 at 2 weeks, 6 weeks, 3 months, 6 months, 12 months and 24 months after surgical treatment to 919 determine which treatment method provides the most rapid recovery.

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Hypothesis: Patients treated with VLPS will have better outcomes at earlier times than those treated 921 with the more conservative techniques, and the better outcomes will persist at the 24-month period.   As described in Section C11 under Aim 1, a small portion of patients may cross over intra-operatively 982 from a randomly assigned procedure of EFP or CRP to VLPS. Whether the analysis is done using intent-983 to-treat or as-treated, such cross-over cases may result in somewhat smaller effect sizes than when 984 there were no cross-over cases. Nonetheless, having outcomes measured longitudinally over a 24-985 month period gives the study adequate power to detect a time-averaged difference between two 986 surgical arms much smaller than the difference based only at 12 months. Specifically, the proposed 987 study gives 80% power to detect a time-averaged difference as small as 4.8 points, using a 0.025 level 988 two-sided test based on mixed-effects model with three follow-up assessments and assuming an SD of 989 18 and a within-person correlation of 0.2. In addition, using the as-treated analysis, in a worst case 990 scenario in which 10% of both EFP and CRP patients cross over to VLPS, sample size will not be equal 991 across the three groups. This, however, will not affect the power significantly. Specifically, we will still The primary analytical approach will be intention-to-treat. An as-treated approach will be used for 999 sensitivity analyses.

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 Backup copies of electronic data should be made at specified intervals.

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The investigators will make every effort to preserve the study subjects' confidentiality. No one other 1293 than study personnel will have access to the study participants' records. Precautions will be taken to 1294 ensure that the records are in a locked cabinet. Records will not have the subjects' names listed on 1295 them, but instead an identification number will be assign to each subject, which only the investigators 1296 and study coordinators will be able to link to subject names. The subjects will also not be identified in 1297 any reports of this study.

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Research material will only be obtained from subjects who consent to participate. The data obtained are 1299 specifically for research purposes and will be maintained in a research study file, separate from the 1300 subject's medical record. Hard copies of the research records will be stored in a locked filing cabinet and 1301 electronic copies will be maintained on a secure server. Subjects will be assigned a unique identification 1302 number. This identification number will be linkable to the subject's identity via a database. The database 1303 will be stored on a secure computer server and will only be accessible by the study coordinators and the 1304 investigator.  Data will be double entered into the web-based data entry system by two separate individuals 1415 at each study site. The data entry system employs an "alert" system if out-of-range data are 1416 entered into the fields. After data have been entered into the data entry system, original hard WRIST Version 7 Protocol R01AR062066-01A1 03April2018 Page 42 of 53 copies of all data will be mailed to the Coordinating Center once a month. Digital copies of x-rays 1418 (labeled with the patient's identification number and date taken) will also be mailed on CD.

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The Coordinating Center will randomly spot-check the data entry for accuracy. Data can only be 1422 edited and downloaded from the web-based system by the Coordinating Center.

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Coordinating Center will request all surveys and data entry forms for the first two months