Extraarticular Distal Radius Malunion
Conditions
Brief summary
This study is designed as a multi-center randomized controlled trial, comparing two groups of patients with symptomatic extra-articular malunited distal radius fractures. One group of patients will undergo corrective surgery of the distal radius, with preoperative computer-assisted planning and virtual osteotomy, and the other group will undergo corrective surgery, with conventional (non-computer-assisted) preoperative planning. The investigators hypothesize that computer-assisted surgical planning will result in a better functional outcome.
Interventions
PROCEDUREComputer-Assisted Surgical Planning
Using a CT reconstructing of affected distal radius and the normal contralateral limb, surgical guides for the osteotomy will be created to assist with surgical planning.
PROCEDUREdistal radius osteotomy
In this control group, the planning and surgical execution of the distal radius osteotomy will be performed as usual, without computer-assisted planning of the osteotomy.
Sponsors
AO foundation
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Extraarticular distal radius malunion requiring surgery * Adult patient (\> 18 yo) * Fluent in English
Exclusion criteria
* Pregnant patient * Prisoner * Abnormal contralateral forearm
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disability of the Shoulder and Hand Score | 0, 3, 6, 12 months | DASH score is a measure of upper extremity function. It ranges 0-100, where higher scores indication more disability and worse upper extremity function. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient-Rated Wrist Evaluation (PWRE_ | 0, 3, 6, 12 months | PRWE score is a measure of wrist function. It ranges 0-100, where higher scores indication more disability and worse wrist function. |
| Numerical Rating Scale for Pain | 0, 3, 6, 12 months | Pain rated on a scale of 0-10, where 0 is no pain and 10 is severe pain |
| Numerical Rating Scale for Satisfaction | 0, 3, 6, 12 months | Satisfaction rated on a scale of 0-10, where 0 is not satisfied and 10 is completely satisfied |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Surgery without computer-assisted planning.
distal radius osteotomy: In this control group, the planning and surgical execution of the distal radius osteotomy will be performed as usual, without computer-assisted planning of the osteotomy. | 17 |
| Computer-Assisted Surgical Planning Computer-Assisted Surgical Planning: Using a CT reconstructing of affected distal radius and the normal contralateral limb, surgical guides for the osteotomy will be created to assist with surgical planning. | 20 |
| Total | 37 |
Baseline characteristics
| Characteristic | Total | Control | Computer-Assisted Surgical Planning |
|---|---|---|---|
| Age, Continuous | 51.2 Years STANDARD_DEVIATION 17.6 | 52.3 Years STANDARD_DEVIATION 15.3 | 50.3 Years STANDARD_DEVIATION 19.6 |
| Sex: Female, Male Female | 28 Participants | 16 Participants | 12 Participants |
| Sex: Female, Male Male | 9 Participants | 1 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 17 | 0 / 20 |
| serious Total, serious adverse events | 0 / 17 | 0 / 20 |
Outcome results
Primary
Disability of the Shoulder and Hand Score
DASH score is a measure of upper extremity function. It ranges 0-100, where higher scores indication more disability and worse upper extremity function.
Time frame: 0, 3, 6, 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Disability of the Shoulder and Hand Score | 0 months | 46.2 Units on a scale | Standard Deviation 25 |
| Control | Disability of the Shoulder and Hand Score | 3 months | 27.9 Units on a scale | Standard Deviation 19 |
| Control | Disability of the Shoulder and Hand Score | 6 months | 23.8 Units on a scale | Standard Deviation 18.9 |
| Control | Disability of the Shoulder and Hand Score | 12 months | 22.8 Units on a scale | Standard Deviation 20.4 |
| Computer-Assisted Surgical Planning | Disability of the Shoulder and Hand Score | 12 months | 18.8 Units on a scale | Standard Deviation 18 |
| Computer-Assisted Surgical Planning | Disability of the Shoulder and Hand Score | 0 months | 51.8 Units on a scale | Standard Deviation 20.6 |
| Computer-Assisted Surgical Planning | Disability of the Shoulder and Hand Score | 6 months | 24.1 Units on a scale | Standard Deviation 20.1 |
| Computer-Assisted Surgical Planning | Disability of the Shoulder and Hand Score | 3 months | 33.8 Units on a scale | Standard Deviation 24 |
Secondary
Numerical Rating Scale for Pain
Pain rated on a scale of 0-10, where 0 is no pain and 10 is severe pain
Time frame: 0, 3, 6, 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Numerical Rating Scale for Pain | 0 months | 5.9 Units on a scale | Standard Deviation 2.8 |
| Control | Numerical Rating Scale for Pain | 3 months | 2.4 Units on a scale | Standard Deviation 2.2 |
| Control | Numerical Rating Scale for Pain | 6 months | 2.6 Units on a scale | Standard Deviation 2.8 |
| Control | Numerical Rating Scale for Pain | 12 months | 2.1 Units on a scale | Standard Deviation 2.8 |
| Computer-Assisted Surgical Planning | Numerical Rating Scale for Pain | 12 months | 2.8 Units on a scale | Standard Deviation 2.1 |
| Computer-Assisted Surgical Planning | Numerical Rating Scale for Pain | 0 months | 6.2 Units on a scale | Standard Deviation 2.5 |
| Computer-Assisted Surgical Planning | Numerical Rating Scale for Pain | 6 months | 3.2 Units on a scale | Standard Deviation 2.4 |
| Computer-Assisted Surgical Planning | Numerical Rating Scale for Pain | 3 months | 3.4 Units on a scale | Standard Deviation 2.3 |
Secondary
Numerical Rating Scale for Satisfaction
Satisfaction rated on a scale of 0-10, where 0 is not satisfied and 10 is completely satisfied
Time frame: 0, 3, 6, 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Numerical Rating Scale for Satisfaction | 0 months | 3.0 Units on a scale | Standard Deviation 1.7 |
| Control | Numerical Rating Scale for Satisfaction | 3 months | 8.4 Units on a scale | Standard Deviation 1.4 |
| Control | Numerical Rating Scale for Satisfaction | 6 months | 7.7 Units on a scale | Standard Deviation 2.2 |
| Control | Numerical Rating Scale for Satisfaction | 12 months | 8.4 Units on a scale | Standard Deviation 1.7 |
| Computer-Assisted Surgical Planning | Numerical Rating Scale for Satisfaction | 12 months | 8.0 Units on a scale | Standard Deviation 1.9 |
| Computer-Assisted Surgical Planning | Numerical Rating Scale for Satisfaction | 0 months | 2.8 Units on a scale | Standard Deviation 5.4 |
| Computer-Assisted Surgical Planning | Numerical Rating Scale for Satisfaction | 6 months | 7.6 Units on a scale | Standard Deviation 1.8 |
| Computer-Assisted Surgical Planning | Numerical Rating Scale for Satisfaction | 3 months | 7.5 Units on a scale | Standard Deviation 2 |
Secondary
Patient-Rated Wrist Evaluation (PWRE_
PRWE score is a measure of wrist function. It ranges 0-100, where higher scores indication more disability and worse wrist function.
Time frame: 0, 3, 6, 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Patient-Rated Wrist Evaluation (PWRE_ | 0 months | 50.4 Units on a scale | Standard Deviation 20.1 |
| Control | Patient-Rated Wrist Evaluation (PWRE_ | 3 months | 28.7 Units on a scale | Standard Deviation 23.4 |
| Control | Patient-Rated Wrist Evaluation (PWRE_ | 6 months | 22.8 Units on a scale | Standard Deviation 16.7 |
| Control | Patient-Rated Wrist Evaluation (PWRE_ | 12 months | 22.3 Units on a scale | Standard Deviation 24.3 |
| Computer-Assisted Surgical Planning | Patient-Rated Wrist Evaluation (PWRE_ | 12 months | 25.3 Units on a scale | Standard Deviation 20.6 |
| Computer-Assisted Surgical Planning | Patient-Rated Wrist Evaluation (PWRE_ | 0 months | 58.2 Units on a scale | Standard Deviation 17.2 |
| Computer-Assisted Surgical Planning | Patient-Rated Wrist Evaluation (PWRE_ | 6 months | 22.8 Units on a scale | Standard Deviation 15 |
| Computer-Assisted Surgical Planning | Patient-Rated Wrist Evaluation (PWRE_ | 3 months | 35.3 Units on a scale | Standard Deviation 28.7 |