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| Name | Class |
|---|---|
| AO foundation | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | Surgery without computer-assisted planning. |
|
| Computer-Assisted Surgical Planning | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computer-Assisted Surgical Planning | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 0, 3, 6, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 0, 3, 6, 12 months |
| Numerical Rating Scale for Pain |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jupiter Jesse, MD | MGH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21156074 | Derived | Leong NL, Buijze GA, Fu EC, Stockmans F, Jupiter JB; Distal Radius Malunion (DiRaM) collaborative group. Computer-assisted versus non-computer-assisted preoperative planning of corrective osteotomy for extra-articular distal radius malunions: a randomized controlled trial. BMC Musculoskelet Disord. 2010 Dec 14;11:282. doi: 10.1186/1471-2474-11-282. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Adult patients electing for corrective osteotomy for symptomatic extra-articular distal radial malunion.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Computer-Assisted Surgical Planning |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | Units on a scale | 0, 3, 6, 12 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rachel Gottlieb, Clinical Research Coordinator | Massachusetts General Hospital | 617.724.4985 | rgottlieb3@mgh.harvard.edu |
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| distal radius osteotomy | Procedure | 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. |
|
Pain rated on a scale of 0-10, where 0 is no pain and 10 is severe pain
| 0, 3, 6, 12 months |
| Numerical Rating Scale for Satisfaction | Satisfaction rated on a scale of 0-10, where 0 is not satisfied and 10 is completely satisfied | 0, 3, 6, 12 months |
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. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| 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. | Posted | Mean | Standard Deviation | Units on a scale | 0, 3, 6, 12 months |
|
|
|
| Secondary | Numerical Rating Scale for Pain | Pain rated on a scale of 0-10, where 0 is no pain and 10 is severe pain | Posted | Mean | Standard Deviation | Units on a scale | 0, 3, 6, 12 months |
|
|
|
| Secondary | Numerical Rating Scale for Satisfaction | Satisfaction rated on a scale of 0-10, where 0 is not satisfied and 10 is completely satisfied | Posted | Mean | Standard Deviation | Units on a scale | 0, 3, 6, 12 months |
|
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| EG001 | 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. | 0 | 20 | 0 | 20 |
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| 6 months |
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| 12 months |
|
| 6 months |
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| 12 months |
|
| 6 months |
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| 12 months |
|