#assignment 1 Hypothetical Baseline Data For Distal Radius Fracture Patients Treated
Introduction
The primary purpose of this study was to compare the standard of care augmented with an inject able bone cement to the standard of care in patients who have experienced a displaced distal radius fracture with respect to a joint-specific patient reported functional outcome, union and malfunction rates, complication rates, and re displacement rates. The secondary purpose was to look at a generic quality of life instrument, time to union, and time to return to previous work.
Method
We conducted a multi-site randomized controlled trial to compare the standard of care augmented with an inject able bone cement to the standard of care in patients experiencing a displaced distal radius fracture.
Subjects
All patients meeting study criteria with a diagnosis of a displaced or unstable extraarticular (AO type A2.1, A2.2, A3.1, A3.2, and A3.3) or simple articular (AO type C1.1, C1.2, C1.3, C2.1, and C2.2) distal radius fracture who were evaluated and treated at one of the participating institutions between June 1, 2005 and May 31, 2005, were asked to participate. Patients were excluded if they had a known drug or alcohol problem, were cognitively impaired/language barrier, were dependent on day to day care and/or unable to walk at the time of injury, had advanced osteoporosis, cancer, motor function disorder, and a history of vascular insufficiency in the upper limb. Fracture types that were excluded were Smith or Barton (volarly displaced) fractures, severely comminuted fractures extending into the diaphysis, multiple extremity fractures, and fractures requiring open surgical reduction or bone grafting. Our investigation, dealing with the study of human subjects, has been approved by the each participating institution’s Human Subjects Review Committee.
Data Collection
All patients meeting study criteria for an unstable and/or displaced distal radius fracture who presented to the one of the participating institutions were asked to participate and give informed consent. A research nurse from each site approached each potential subject to inquire about their interest and eligibility in volunteering for this study. This inquiry included a series of questions to confirm eligibility, a description of the study, its importance in orthopedic patient care, the responsibilities for participating, and the potential benefits of participating. Study aids focused for study education and support included a patient information booklet and a toll free telephone number for advice in case of complications or questions regarding follow up visits.
Patients were followed immediately after injury to 12 months after initial management. This included a baseline evaluation and planned visits at 3, 6, and 9 weeks, and 3, 6, and 12 months after injury. Patients received telephone reminders for upcoming study visits no less frequently than once every two months.
Study data was entered during the course of the study from the CRF to a secure central database through an internet portal. Data entry was validated (i.e. logic checks including range checks, missing value checks, etc.) both by visual inspection and built-in database programming during the data entry process.
Monitoring of the study occurred regularly both remotely and through site visits. This included ensuring all CRFs were completed without missing data, that CRFs matched source documentation, and that all scheduled and unscheduled visits were documented. Inconsistencies were resolved by contacting the patient, their physician, or querying the patient’s medical record.
The primary purpose of this study was to compare the standard of care augmented with an inject able bone cement to the standard of care in patients who have experienced a displaced distal radius fracture with respect to a joint-specific patient reported functional outcome, union and malfunction rates, complication rates, and re displacement rates. The secondary purpose was to look at a generic quality of life instrument, time to union, and time to return to previous work.
The elderly population is rapidly increasing worldwide, accompanied by increases in instances of degenerative spinal diseases that accompany osteoporosis, such as spondylolisthesis, intervertebral disk protrusion, spinal canal stenosis and vertebral compression fractures. These diseases reduce bone quality and the stability of the spine and ultimately lead to pronounced lower back pain or radiating pain in the lower limbs and activity limitations. Many methods are used for posterior internal fixation, including Harrington rods, Luque rods and Cotrel-Dubousset instrumentation. Pedicle screw instrumentation is the most widely used method for the posterior fixation of patients' vertebrae. However, when pedicle screws are used in the osteoporotic spine, the internal fixation strength of the pedicle screws decreases significantly due to low bone mineral density (BMD), which results in an increased risk of the screws loosening and pulling out. Enhancing the screw fixation strength in patients with osteoporosis is currently a challenge for spinal surgeons.
Various methods have been suggested to increase screw fixation strength in osteoporotic patients, including improving the design of the screw-rod, increasing the diameter or length of the pedicle screw and using a cannulated pedicle screw for polymethylmethacrylate (PMMA) augmentation. All of these strategies have potential disadvantages, such as the screw loosening or pulling out, vascular or visceral injury and complications associated with PMMA leakage. Thus, new techniques are needed to improve the effectiveness and safety of procedures for osteoporotic patients. However, hardened PMMA is very strong and PMMA-augmented cannulated screw fixation is still considered the most efficient method in this field.
This study reports our clinical experience using an improved cannulated screw and novel bone cement design in patients with spinal diseases and osteoporosis who underwent posterior internal fixation. The main differences between this screw and other products are the new screw's special side holes and screw head design. The screw's three side holes can more broadly distribute the PMMA and the multi-axis/single-axis screw head can decrease the difficulty of using a screw in surgical procedures, especially in patients undergoing surgery for spondylolisthesis and degenerative scoliosis.
The purpose of this paper is to describe and recommend a new surgical approach using a PMMA-augmented cannulated screw and to investigate the occurrence of pain and spinal disability after using this approach in patients with osteoporosis and coexisting degenerative spinal diseases.
We conducted a multi-site randomized controlled trial to compare the standard of care augmented with an inject able bone cement to the standard of care in patients experiencing a displaced distal radius fracture.
Subjects
All patients meeting study criteria with a diagnosis of a displaced or unstable extraarticular (AO type A2.1, A2.2, A3.1, A3.2, and A3.3) or simple articular (AO type C1.1, C1.2, C1.3, C2.1, and C2.2) distal radius fracture who were evaluated and treated at one of the participating institutions between June 1, 2005 and May 31, 2005, were asked to participate. Patients were excluded if they had a known drug or alcohol problem, were cognitively impaired/language barrier, were dependent on day to day care and/or unable to walk at the time of injury, had advanced osteoporosis, cancer, motor function disorder, and a history of vascular insufficiency in the upper limb. Fracture types that were excluded were Smith or Barton (volarly displaced) fractures, severely comminuted fractures extending into the diaphysis, multiple extremity fractures, and fractures requiring open surgical reduction or bone grafting. Our investigation, dealing with the study of human subjects, has been approved by the each participating institution’s Human Subjects Review Committee.
Data Collection
All patients meeting study criteria for an unstable and/or displaced distal radius fracture who presented to the one of the participating institutions were asked to participate and give informed consent. A research nurse from each site approached each potential subject to inquire about their interest and eligibility in volunteering for this study. This inquiry included a series of questions to confirm eligibility, a description of the study, its importance in orthopedic patient care, the responsibilities for participating, and the potential benefits of participating. Study aids focused for study education and support included a patient information booklet and a toll free telephone number for advice in case of complications or questions regarding follow up visits.
Patients were followed immediately after injury to 12 months after initial management. This included a baseline evaluation and planned visits at 3, 6, and 9 weeks, and 3, 6, and 12 months after injury. Patients received telephone reminders for upcoming study visits no less frequently than once every two months.
Study data was entered during the course of the study from the CRF to a secure central database through an internet portal. Data entry was validated (i.e. logic checks including range checks, missing value checks, etc.) both by visual inspection and built-in database programming during the data entry process.
Monitoring of the study occurred regularly both remotely and through site visits. This included ensuring all CRFs were completed without missing data, that CRFs matched source documentation, and that all scheduled and unscheduled visits were documented. Inconsistencies were resolved by contacting the patient, their physician, or querying the patient’s medical record.
Data entry was validated (i.e. logic checks including range checks, missing value checks, etc.) both by visual inspection and built-in database programming during the data entry process.
The following prognostic variables were identified in the Trauma registry and verified by the patient baseline questionnaire:
- Patient age, gender, occupation
- AO Fracture classification
- Gustillo classification
- Currently receiving Worker’s Compensation
- Post-operative alignment
- Smoking status
- Alcoholic
Furthermore, the following short term outcome measures were obtained from the Trauma Registry:
- Length of hospital stay
- Post-operative complications (e.g., superficial and deep infection, pin-site infections, re-operation)
Lastly, we provided in the study packet the following generic and disease specific patient reported outcomes that the patients were instructed in over the phone and by written instruction in the study packet:
Generic instrument: SF-36- Composed of 8 subscales measuring physical and mental health (36 items). For each subscale, scores range from 0 to 100 points. The higher the score the higher the function.
Disease-specific instrument: Foot and Ankle Outcome Score (FAOS)- Composed of 5 subscales including pain, symptoms, ADLs, sports and recreation, and quality of life. Scores are normalized and range from 0 to 100 points. The higher the score, the higher the function.
Data Analysis
For categorical variables, proportions and frequency counts were calculated. For continuous variables, means and standard deviations were computed. In addition, minimum, maximum, and range will be reported for both types of variables. Missing, extreme, and variable distributions were explored. Group comparisons of categorical variables were made using Pearson’s chi-square (χ2) tests and continuous variables using t-tests
For primary aims, the differences in PRWE scores between injectable cement and standard of care groups were tested first with t-tests and then with analysis of variance (ANOVA) to control for potential confounding variables. This outcome was dichotomized at its mean value and analyzed using a Cox regression to estimate the relative risk and the 95% confidence interval of an “unfavorable” outcome (ie, below the mean) comparing the two groups, while controlling for potential confounders. Rates of union, malunion, complications, and redisplacement, were compared using a Cox regression to estimate the relative risk and 95% confidence intervals at different time points.
To facilitate the use of this model as a practical prediction rule, we used the dichotomized PRWE scores and labeled the outcome as “favorable” or “unfavorable”. The optimal point at which to dichotomize the outcome was chosen by running a series of logistic regression analyses to identify the dichotomous variables possessing the most explanatory power. In the end, the data was normally distributed so we dichotomized each score at the mean value. We felt the mean scores represented pain and activities of daily living scores that were functional and satisfactory. The other two outcomes that we attempted to predict were malunion and redisplacement.
We first estimated the association between each prognostic factor and each outcome (bivariate analysis). The initial multivariate model included all candidate predictors. Independent predictors of outcome were identified by forward stepwise logistic regression where all univariate predictors with a p-value ≤ 0.05 were included. Final models were determined by prognostic factors that accounted for the majority of the variance (R2 value). Statistical assumptions were verified graphically. Models were examined to determine if multicollinearity was present using condition number and variance inflation factors. Furthermore, outliers and influential values were identified using studentized residuals and Cook distances. A modified bootstrap approach (random sampling with replacement) was used to obtain several internal validation samples.
Descriptive Statistics
| | PInjectable cement (N=24) | | Standard of care (N=44) | ||
|---|---|---|---|---|---|
| | No. or mean | % or range | | No. or mean | % or range |
| Age (years) | 61 | (45-84) | | 62 | (47-81) |
| Male | 37 | 18 | | 46 | 22 |
| Smoker | 27 | 13.2 | | 36 | 17.3 |
| Fracture type | | | | | |
| Intraarticular | 86 | 42 | | 89 | 43 |
| Extraarticular | 118 | 58 | | 119 | 57 |
| Side of injury | | | | | |
| Dominant hand | 104 | 51 | | 110 | 53 |
| Nondominant hand | 100 | 49 | | 98 | 4 |
Analytical Statistics
1. Primary Outcomes
| Treatment | N | Mean | SD | Min | Max | P-value† |
|---|---|---|---|---|---|---|
| Follow-up(months) | | 3 | 12 | 3 | 12 | 3 12 |
| PRWE | | | | | | |
| Injectable cement | 204 | 28 | 13 | 19.7 | 17.5 | <0.001 <0.001 |
| Standard of care | 208 | 41 | 21 | 22.4 | 16.2 | |
Hypothetical outcomes comparing the inject able cement to the standard of care.
| Treatment group | | ||||
|---|---|---|---|---|---|
| | Injectable cement (N=204) | Standard of care (N=208) | P-value* | ||
| Outcome | n | % | n | % | |
| Malunion | 16 | 8 | 31 | 15 | 0.02 |
| Redisplacement | 45 | 22 | 40 | 19 | 0.45 |
| Complications | 78 | 38 | 71 | 34 | 0.39 |
| Treatment (T) (n=204) | Control (C) (n=208) | RR | RRR | RD | NMT |
| No. (%) | No. (%) | T/C | 1-(T/C) | C-T | 1/(C-T) |
| 16 (8) | 31 (15) | 1.9 | 0.90 | 0.07 | 14 |
2. Secondary outcomes
| Treatment | Injectable cement (N=204) | Standard plate (N=208) | P-value* | ||
|---|---|---|---|---|---|
| | Mean | SD | Mean | SD | |
| Time to union(weeks) | 9 | 2.3 | 10 | 3.1 | 0.0002 |
| Time to work (weeks) | 12 | 4.1 | 15 | 5.7 | <0.001 |
Conclusion
How big data help to solve the problem by the data are presented as the mean ± standard deviation (SD) and were analyzed using SPSS for Windows ver. 13.0 (SPSS Inc., Chicago, IL). The paired t-test was performed to compare continuous variables, including preoperative and final VAS and ODI scores. A p-value of less than 0.05 was considered significant.
Patients who experience a displaced distal radius fracture that receive cast immobilization or external fixation augmented with an injectable bone cement have fewer malunions, have less pain, and perform better in their activities of daily living at several points in time after their first year of injury compared to patients that are just with cast or external fixation alone. Furthermore, those treated with injectable cement achieve bony union and return to work earlier. Older patients, with more severe fractures, especially in their dominant extremity, have more pain and reduced function in their activities of daily living.
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