Trial Outcomes & Findings for Computer Assisted Planing of Corrective Osteotomy for Distal Radius Malunion (NCT NCT01193010)
NCT ID: NCT01193010
Last Updated: 2019-06-21
Results Overview
DASH score is a measure of upper extremity function. It ranges 0-100, where higher scores indication more disability and worse upper extremity function.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
0, 3, 6, 12 months
Results posted on
2019-06-21
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
17
|
20
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Computer Assisted Planing of Corrective Osteotomy for Distal Radius Malunion
Baseline characteristics by cohort
| Measure |
Control
n=17 Participants
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.
|
Computer-Assisted Surgical Planning
n=20 Participants
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.
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.3 Years
STANDARD_DEVIATION 15.3 • n=5 Participants
|
50.3 Years
STANDARD_DEVIATION 19.6 • n=7 Participants
|
51.2 Years
STANDARD_DEVIATION 17.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0, 3, 6, 12 monthsDASH score is a measure of upper extremity function. It ranges 0-100, where higher scores indication more disability and worse upper extremity function.
Outcome measures
| Measure |
Control
n=17 Participants
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.
|
Computer-Assisted Surgical Planning
n=20 Participants
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.
|
|---|---|---|
|
Disability of the Shoulder and Hand Score
0 months
|
46.2 Units on a scale
Standard Deviation 25.0
|
51.8 Units on a scale
Standard Deviation 20.6
|
|
Disability of the Shoulder and Hand Score
3 months
|
27.9 Units on a scale
Standard Deviation 19.0
|
33.8 Units on a scale
Standard Deviation 24.0
|
|
Disability of the Shoulder and Hand Score
6 months
|
23.8 Units on a scale
Standard Deviation 18.9
|
24.1 Units on a scale
Standard Deviation 20.1
|
|
Disability of the Shoulder and Hand Score
12 months
|
22.8 Units on a scale
Standard Deviation 20.4
|
18.8 Units on a scale
Standard Deviation 18.0
|
SECONDARY outcome
Timeframe: 0, 3, 6, 12 monthsPRWE score is a measure of wrist function. It ranges 0-100, where higher scores indication more disability and worse wrist function.
Outcome measures
| Measure |
Control
n=17 Participants
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.
|
Computer-Assisted Surgical Planning
n=20 Participants
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.
|
|---|---|---|
|
Patient-Rated Wrist Evaluation (PWRE_
0 months
|
50.4 Units on a scale
Standard Deviation 20.1
|
58.2 Units on a scale
Standard Deviation 17.2
|
|
Patient-Rated Wrist Evaluation (PWRE_
3 months
|
28.7 Units on a scale
Standard Deviation 23.4
|
35.3 Units on a scale
Standard Deviation 28.7
|
|
Patient-Rated Wrist Evaluation (PWRE_
6 months
|
22.8 Units on a scale
Standard Deviation 16.7
|
22.8 Units on a scale
Standard Deviation 15.0
|
|
Patient-Rated Wrist Evaluation (PWRE_
12 months
|
22.3 Units on a scale
Standard Deviation 24.3
|
25.3 Units on a scale
Standard Deviation 20.6
|
SECONDARY outcome
Timeframe: 0, 3, 6, 12 monthsPain rated on a scale of 0-10, where 0 is no pain and 10 is severe pain
Outcome measures
| Measure |
Control
n=17 Participants
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.
|
Computer-Assisted Surgical Planning
n=20 Participants
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.
|
|---|---|---|
|
Numerical Rating Scale for Pain
0 months
|
5.9 Units on a scale
Standard Deviation 2.8
|
6.2 Units on a scale
Standard Deviation 2.5
|
|
Numerical Rating Scale for Pain
3 months
|
2.4 Units on a scale
Standard Deviation 2.2
|
3.4 Units on a scale
Standard Deviation 2.3
|
|
Numerical Rating Scale for Pain
6 months
|
2.6 Units on a scale
Standard Deviation 2.8
|
3.2 Units on a scale
Standard Deviation 2.4
|
|
Numerical Rating Scale for Pain
12 months
|
2.1 Units on a scale
Standard Deviation 2.8
|
2.8 Units on a scale
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: 0, 3, 6, 12 monthsSatisfaction rated on a scale of 0-10, where 0 is not satisfied and 10 is completely satisfied
Outcome measures
| Measure |
Control
n=17 Participants
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.
|
Computer-Assisted Surgical Planning
n=20 Participants
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.
|
|---|---|---|
|
Numerical Rating Scale for Satisfaction
0 months
|
3.0 Units on a scale
Standard Deviation 1.7
|
2.8 Units on a scale
Standard Deviation 5.4
|
|
Numerical Rating Scale for Satisfaction
3 months
|
8.4 Units on a scale
Standard Deviation 1.4
|
7.5 Units on a scale
Standard Deviation 2.0
|
|
Numerical Rating Scale for Satisfaction
6 months
|
7.7 Units on a scale
Standard Deviation 2.2
|
7.6 Units on a scale
Standard Deviation 1.8
|
|
Numerical Rating Scale for Satisfaction
12 months
|
8.4 Units on a scale
Standard Deviation 1.7
|
8.0 Units on a scale
Standard Deviation 1.9
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Computer-Assisted Surgical Planning
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Rachel Gottlieb, Clinical Research Coordinator
Massachusetts General Hospital
Phone: 617.724.4985
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place