Long vs Extended-short Nail When Treating Proximal Femur Fractures
1 other identifier
interventional
800
1 country
2
Brief Summary
Fractures of the upper part of the femur may be treated with intramedullary nails. There are different designs to choose from. The intention of this RCT is to compare two nails with some of the same properties, but with different lengths. Usually, it is the surgeon who decides which nail to be used. The literature indicates that there is a lack of good evidence in the decision-making, and that the choice often depends on personal preferences and experience of the surgeon. Therefore, the investigators want to compare whether one of the nails has a better outcome than the other, and in that way be able to give some clearer guidelines for treatment. Patients will be randomized into two groups, one receiving a long nail and one receiving an extended-short nail and compare surgical and functional outcomes. Information from the operation and subsequent check-ups will be analysed. The hypothesis is that the extended-short nail can reduce operating time, bleeding, fluoroscopy time and give equal or better functional outcome, without increasing reoperation rates or mortality.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2020
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 26, 2020
CompletedStudy Start
First participant enrolled
December 1, 2020
CompletedFirst Posted
Study publicly available on registry
December 3, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedMay 29, 2024
May 1, 2024
3.9 years
November 26, 2020
May 27, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Difference in Short Physical Performance Battery (SPPB)-score
Short Physical Performance Battery (SPPB)-score, ranges from 0-12, 12 is the best indicating a good physical function.
At 3 months and 1 year
Secondary Outcomes (9)
Difference in Operation time
Surgery date
Difference in Blood loss
Surgery date
Difference in Harris Hip score
3 months and 1 year
Difference in EQ5D-5L (EuroQoL 5L - health-related quality of life)
3 months and 1 year
Difference in Transfusion after surgery
2 weeks after surgery
- +4 more secondary outcomes
Study Arms (2)
Extended-Short Nail
ACTIVE COMPARATORImplantation of TFNA extended-short nail (235 mm)
Long nail
ACTIVE COMPARATORImplantation of TFNA long nail (260-480 mm)
Interventions
The extended short version of the TFN-advanced proximal femoral nailing system (TFNA)
The long version of the TFN-advanced proximal femoral nailing system (TFNA)
Eligibility Criteria
You may qualify if:
- Intertrochanteric, pertrochanteric or subtrochanteric fractures
- Distal fracture limit within 4 cm below the trochanter minor
- Intramedullary nailing with TFNA-nail is indicated
- Patient is fit for surgery.
You may not qualify if:
- AO 31-A3 fractures (revers oblique fractures)
- Cognitively impaired patients who themselves cannot understand the study information and give informed consent, and do not have a next of kin or legal guardian who can give consent on their behalf.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Drammen Hospital, Vestre Viken HF
Drammen, 3004, Norway
Kongsberg hospital, Vestre Viken HF
Kongsberg, 3612, Norway
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Heidi B Dyrop, MD, PHD
Orthopedic Dpt, Kongsberg Hospital, Vestre Viken HF
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 26, 2020
First Posted
December 3, 2020
Study Start
December 1, 2020
Primary Completion
November 1, 2024
Study Completion
December 1, 2025
Last Updated
May 29, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share