Trial Outcomes & Findings for Intramedullary Nailing of the Femur:Trochanteric vs Piriformis Starting Portals (NCT NCT00593333)
NCT ID: NCT00593333
Last Updated: 2017-06-05
Results Overview
Time to clinically healed fracture as measured by weeks.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
110 participants
Primary outcome timeframe
baseline to healed fracture (weeks)
Results posted on
2017-06-05
Participant Flow
Study started in June 2003. Primary completion date December 2008. Study completion date December 2008. Patients were recruited at University of Alabama at Birmingham.
Participant milestones
| Measure |
Standard Treatment
Piriformis fossa entry portal for the antegrade nailing was used for this group. Received either a TRIGEN antegrade femoral nail manufactured by Smith \& Nephew (Memphis, Tennessee) or an Antegrade Femoral Nail manufactured by Synthes (West Chester, Pennsylvania)
|
Trigen
Trochanteric entry portal for the antegrade nailing was used for this group. These subjects received a TRigen Trochanteric Angegrade Nail (TAN) manufactured by Smith \& Nephew that incorporates a 4 degree valgus bend in the proximal aspect of the nail.
|
|---|---|---|
|
Overall Study
STARTED
|
54
|
56
|
|
Overall Study
COMPLETED
|
44
|
45
|
|
Overall Study
NOT COMPLETED
|
10
|
11
|
Reasons for withdrawal
| Measure |
Standard Treatment
Piriformis fossa entry portal for the antegrade nailing was used for this group. Received either a TRIGEN antegrade femoral nail manufactured by Smith \& Nephew (Memphis, Tennessee) or an Antegrade Femoral Nail manufactured by Synthes (West Chester, Pennsylvania)
|
Trigen
Trochanteric entry portal for the antegrade nailing was used for this group. These subjects received a TRigen Trochanteric Angegrade Nail (TAN) manufactured by Smith \& Nephew that incorporates a 4 degree valgus bend in the proximal aspect of the nail.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
10
|
11
|
Baseline Characteristics
Intramedullary Nailing of the Femur:Trochanteric vs Piriformis Starting Portals
Baseline characteristics by cohort
| Measure |
Standard Treatment
n=54 Participants
Pirformis fossa entry portal for the antegrade nailing was used for this group. Received either a TRIGEN antegrade femoral nail or an Antegrade Femoral Nail.
|
Trigen
n=56 Participants
Trochanteric entry portal for the antegrade nailing was used for this group. These subjects received a TRigen Trochanteric Angegrade Nail (TAN) that incorporates a 4 degree valgus bend in the proximal aspect of the nail.
|
Total
n=110 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
53 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline to healed fracture (weeks)Time to clinically healed fracture as measured by weeks.
Outcome measures
| Measure |
Standard Treatment
n=44 Participants
Piriformis fossa entry portal for the antegrade nailing was used for this group. Received either a TRIGEN antegrade femoral nail manufactured by Smith \& Nephew (Memphis, Tennessee) or an Antegrade Femoral Nail manufactured by Synthes (West Chester, Pennsylvania)
|
Trigen
n=45 Participants
Trochanteric entry portal for the antegrade nailing was used for this group. These subjects received a TRigen Trochanteric Angegrade Nail (TAN) manufactured by Smith \& Nephew that incorporates a 4 degree valgus bend in the proximal aspect of the nail.
|
|---|---|---|
|
Healed Femur Fracture
|
31.8 Weeks
Interval 10.3 to 64.3
|
31.4 Weeks
Interval 6.3 to 108.1
|
Adverse Events
Group A
Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths
Group B
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group A
n=54 participants at risk
Piriformis fossa entry portal for the antegrade nailing was used for this group. Received either a TRIGEN antegrade femoral nail manufactured by Smith \& Nephew (Memphis, Tennessee) or an Antegrade Femoral Nail manufactured by Synthes (West Chester, Pennsylvania)
|
Group B
n=56 participants at risk
Trochanteric entry portal for the antegrade nailing was used for this group. These subjects received a TRigen Trochanteric Angegrade Nail (TAN) manufactured by Smith \& Nephew that incorporates a 4 degree valgus bend in the proximal aspect of the nail.
|
|---|---|---|
|
Surgical and medical procedures
Hematoma requiring surgical intervention
|
3.7%
2/54 • Number of events 2 • Subjects were followed through 12 months after intervention
|
1.8%
1/56 • Number of events 1 • Subjects were followed through 12 months after intervention
|
|
Surgical and medical procedures
Implant failure requiring revision
|
1.9%
1/54 • Number of events 1 • Subjects were followed through 12 months after intervention
|
0.00%
0/56 • Subjects were followed through 12 months after intervention
|
Other adverse events
| Measure |
Group A
n=54 participants at risk
Piriformis fossa entry portal for the antegrade nailing was used for this group. Received either a TRIGEN antegrade femoral nail manufactured by Smith \& Nephew (Memphis, Tennessee) or an Antegrade Femoral Nail manufactured by Synthes (West Chester, Pennsylvania)
|
Group B
n=56 participants at risk
Trochanteric entry portal for the antegrade nailing was used for this group. These subjects received a TRigen Trochanteric Angegrade Nail (TAN) manufactured by Smith \& Nephew that incorporates a 4 degree valgus bend in the proximal aspect of the nail.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Implant failure not requiring surgical intervention
|
1.9%
1/54 • Number of events 1 • Subjects were followed through 12 months after intervention
|
8.9%
5/56 • Number of events 5 • Subjects were followed through 12 months after intervention
|
|
Musculoskeletal and connective tissue disorders
Healed with malalignment
|
11.1%
6/54 • Number of events 6 • Subjects were followed through 12 months after intervention
|
5.4%
3/56 • Number of events 3 • Subjects were followed through 12 months after intervention
|
Additional Information
Taylor Vlack, Research Nurse Coordinator
Department of Surgery/Division of Orthopaedics
Phone: 205-996-6781
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place