Hip FracturesNCT04652310
Long vs Extended-short Nail When Treating Proximal Femur Fractures
A study testing TFNA extended-short nail (235 mm) and TFNA long nail (260-480mm) in people with Hip Fractures, run by Vestre Viken Hospital Trust at 2 sites in Norway.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hip Fractures
- What is being tested?
- TFNA extended-short nail (235 mm) and TFNA long nail (260-480mm)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 2 sitesNorway
- Study dates
- 1 Dec 2020to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Norway2 sites, 2 recruiting
- Recruiting
Drammen Hospital, Vestre Viken HF
Drammen, 3004
Magnus Talen, MD, magtal@vestreviken.no
Lukas Månsson, MD, Lukas.Mansson@vestreviken.no
- Recruiting
Kongsberg hospital, Vestre Viken HF
Kongsberg, 3612
Heidi B Dyrop, MD, PHD, +4799030104, heidyr@vestreviken.no
Andreas Stangeby, MD, +4793457441, antsta@vestreviken.no
About this study
Official title: Long vs Extended-short Nail When Treating Proximal Femur Fractures - An RCT-study Examining Differences in Functional and Surgical Outcomes
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.
Read the detailed description
Background Intramedullary nails have in recent years become the preferred technique compared to DHS when treating proximal femur fractures. A Norwegian RCT has showed the same frequency of postoperative pain, functional outcome and rate of reoperations comparing the two techniques. Nails are usually provided in a long and short model. Deciding which nail length to use is highly discussed, and often a long nail is preferred, because it gives a theoretically more stable and secure fixation of the femur. There are, however many advantages of using a short nail. It is less time consuming as there is no need for reaming, securing the long nail distally requires more fluoroscopy time, and distal locking of the long nail has also been shown to increase the risk of perioperative fractures. Perioperative bleeding and postoperative blood transfusions are reduced when using a short nail, and a long nail may also give more pain distally around the thigh and around the knee owing to cortical impingement. Finally, the long nail is more expensive compared to short models. There is a perception in the orthopedic society that there's a higher risk of periprosthetic fractures with short nails, but the latest generations of nails have improved this problem. Most studies report no difference in periprostetic fractures between long and short nails. Recently, new extended-short versions of medullary nails are being produced. The extended-short nail combines the mechanical properties seen in a long nail and the surgical simplicity of a short nail. This new nail type may replace the use of several long nails being placed just to be on the safe side, and thus reduce operating time, bleeding and postoperative pain associated with a long nail. Biomechanical studies have showed that the mechanical properties of long and extended-short nails are predominantly comparable, but to our knowledge no clinical studies comparing the extended-short and long nails have been performed to date. The advantages of an extended-short nail are potentially great, which makes it important to clarify which opportunities there are to benefit from this type of nail for certain types of fractures, both in the interest of the patient as well as the economic healthcare perspective.
Purpose In a well-defined population of patients with proximal femur fractures within a certain anatomical area the aim is to compare the extended-short nail with the long nail, to evaluate differences in functional and surgical outcome.
- Conditions
- Hip Fractures
- Being tested
- TFNA extended-short nail (235 mm), TFNA long nail (260-480mm)
- Keywords
- intramedullary nailing, TFNA
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TFNA extended-short nail (235 mm)Device
Also called TFN-advanced proximal femoral nailing system (TFNA) 235 mm
The extended short version of the TFN-advanced proximal femoral nailing system (TFNA)
TFNA long nail (260-480mm)Device
Also called TFN-advanced proximal femoral nailing system (TFNA) 260-480mm
The long version of the TFN-advanced proximal femoral nailing system (TFNA)
| Study group | Role | What they receive |
|---|---|---|
| Extended-Short Nail | Active comparator | Implantation of TFNA extended-short nail (235 mm) Receives: Device: TFNA extended-short nail (235 mm) |
| Long nail | Active comparator | Implantation of TFNA long nail (260-480 mm) Receives: Device: TFNA long nail (260-480mm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 3 months and 1 year
Secondary outcomes (9)
Difference in Operation time
Operation time in minutes
Measured: Surgery date
Difference in Blood loss
Blood loss during surgery
Measured: Surgery date
Difference in Harris Hip score
Harris Hip score, ranges from 0-100, 100 is the best score, a high score indicates good physical function.
Measured: 3 months and 1 year
Difference in EQ5D-5L (EuroQoL 5L - health-related quality of life)
EQ5D-5L (EuroQoL 5L - health-related quality of life)measures health status terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Mobility dimension asks about the person's walking ability. Self-care dimension asks about the ability to wash or dress by oneself, and usual activities dimension measures performance in "work, study, housework, family or leisure activities". In pain/discomfort dimension, it asks how much pain or discomfort they have, and in anxiety/depression dimension, it asks how anxious or depressed they are. The respondents self-rate their level of severity for each dimension using three-level (EQ-5D-3L) or five-level (EQ-5D-5L) scale
Measured: 3 months and 1 year
Difference in Transfusion after surgery
Need for transfusion of blood products after surgery
Measured: 2 weeks after surgery
Difference in Fluoroscopy time
Fluoroscopy time during surgery
Measured: Surgery date
Difference in Postoperative complications
Any postoperative complications
Measured: Minimally 1 year
Difference in Mortality
Mortality after surgery
Measured: Minimally 1 year
Difference in Reoperations
Reoperations of any kind
Measured: Minimally 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start1 Dec 2020
- Primary completionNov 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vestre Viken Hospital Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heidi B Dyrop, MD, PHD, Principal investigator, Orthopedic Dpt, Kongsberg Hospital, Vestre Viken HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04652310
- Sponsor's protocol ID
- REK 2019/125
- Status last verified
- May 2024
- First submitted
- 26 Nov 2020
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long vs Extended-short Nail When Treating Proximal Femur Fractures - An RCT-study Examining Differences in Functional and Surgical Outcomes
- ClinicalTrials.gov ID
- NCT04652310
- Acronym / sponsor ID
- REK 2019/125
- Conditions
- Hip Fractures
- Keywords
- intramedullary nailing, TFNA
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Vestre Viken Hospital TrustUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 3 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background Intramedullary nails have in recent years become the preferred technique compared to DHS when treating proximal femur fractures. A Norwegian RCT has showed the same frequency of postoperative pain, functional outcome and rate of reoperations comparing the two techniques. Nails are usually provided in a long and short model. Deciding which nail length to use is highly discussed, and often a long nail is preferred, because it gives a theoretically more stable and secure fixation of the femur. There are, however many advantages of using a short nail. It is less time consuming as there is no need for reaming, securing the long nail distally requires more fluoroscopy time, and distal locking of the long nail has also been shown to increase the risk of perioperative fractures. Perioperative bleeding and postoperative blood transfusions are reduced when using a short nail, and a long nail may also give more pain distally around the thigh and around the knee owing to cortical impingement. Finally, the long nail is more expensive compared to short models. There is a perception in the orthopedic society that there's a higher risk of periprosthetic fractures with short nails, but the latest generations of nails have improved this problem. Most studies report no difference in periprostetic fractures between long and short nails. Recently, new extended-short versions of medullary nails are being produced. The extended-short nail combines the mechanical properties seen in a long nail and the surgical simplicity of a short nail. This new nail type may replace the use of several long nails being placed just to be on the safe side, and thus reduce operating time, bleeding and postoperative pain associated with a long nail. Biomechanical studies have showed that the mechanical properties of long and extended-short nails are predominantly comparable, but to our knowledge no clinical studies comparing the extended-short and long nails have been performed to date. The advantages of an extended-short nail are potentially great, which makes it important to clarify which opportunities there are to benefit from this type of nail for certain types of fractures, both in the interest of the patient as well as the economic healthcare perspective.
Purpose In a well-defined population of patients with proximal femur fractures within a certain anatomical area the aim is to compare the extended-short nail with the long nail, to evaluate differences in functional and surgical outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extended-Short Nail | Active comparator | Device: TFNA extended-short nail (235 mm)Implantation of TFNA extended-short nail (235 mm) |
| Long nail | Active comparator | Device: TFNA long nail (260-480mm)Implantation of TFNA long nail (260-480 mm) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TFNA extended-short nail (235 mm)Also: TFN-advanced proximal femoral nailing system (TFNA) 235 mmThe extended short version of the TFN-advanced proximal femoral nailing system (TFNA) | Device | Extended-Short Nail |
| TFNA long nail (260-480mm)Also: TFN-advanced proximal femoral nailing system (TFNA) 260-480mmThe long version of the TFN-advanced proximal femoral nailing system (TFNA) | Device | Long nail |
Primary outcome
Difference in Short Physical Performance Battery (SPPB)-score
Time frame: At 3 months and 1 year
Short Physical Performance Battery (SPPB)-score, ranges from 0-12, 12 is the best indicating a good physical function.
9 secondary outcomes
Difference in Operation time
Time frame: Surgery date
Difference in Blood loss
Time frame: Surgery date
Difference in Harris Hip score
Time frame: 3 months and 1 year
Difference in EQ5D-5L (EuroQoL 5L - health-related quality of life)
Time frame: 3 months and 1 year
Difference in Transfusion after surgery
Time frame: 2 weeks after surgery
Difference in Fluoroscopy time
Time frame: Surgery date
Difference in Postoperative complications
Time frame: Minimally 1 year
Difference in Mortality
Time frame: Minimally 1 year
Difference in Reoperations
Time frame: Minimally 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heidi B Dyrop, MD, PHD principal investigator
Orthopedic Dpt, Kongsberg Hospital, Vestre Viken HF
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TFNA extended-short nail (235 mm) and TFNA long nail (260-480mm) in people with Hip Fractures, run by Vestre Viken Hospital Trust at 2 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Heidi B Dyrop, MD, PHD (+4799030104, heidyr@vestreviken.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Short Physical Performance Battery (SPPB)-score (time frame: At 3 months and 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2024.