Hip Injuries and DisordersTUFHIPRCTNCT04868305
Intramedullary Nail Versus Hip Arthroplasty in Unstable Trochanteric Hip Fractures
A study testing Intramedullary nail and Hip arthroplasty in people with Hip Injuries and Disorders and Hip Fractures, run by Helse Stavanger HF at 1 site in Norway.
Trial summary
A hip fracture is a large burden to the patient with increased mortality, pain and increased need for daily assistance. Trochanteric fractures of the femur (FTF) represents about 35% of the hip fractures. Read more about this study
- Who is it for?
- Ages 65 to 120 years
- Conditions the study is for
- Hip Injuries and Disorders, Hip Fractures
- What is being tested?
- Intramedullary nail and Hip arthroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteNorway
- Study dates
- 12 Oct 2021to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 to 120 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥ 65 years
- American Society of Anesthesiology Score (ASA) < 4
- Ambulant with or without aid (preinjury)
- Radiological verified unstable trochanteric hip fracture (AO 31A2.2 - 3.3)
- Written consent obtained by patient or his/her next of kin
Who cannot join
- Previous hip surgery on ipsilateral or contralateral side
- Non-ambulant preinjury
- Patient not living in the area of hospital care
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Stavanger University Hospital
Stavanger
Thomas Woldeyesus, MD
About this study
Official title: Randomized Clinical Trial: Treatment of Unstable Trochanteric Hip Fractures With Intramedullary Nail Versus Hip Arthroplasty: Survival, Complications and Postoperative Patient Reported Outcomes
A hip fracture is a large burden to the patient with increased mortality, pain and increased need for daily assistance. Trochanteric fractures of the femur (FTF) represents about 35% of the hip fractures. Today FTFs are mainly treated with internal fixation using sliding hips screws (SHS) or intramedullary nail (IMN), whilst hip arthroplasty (THA/HA) is rarely used. Despite advances in the design of the internal fixation implants there is a high failure rate, in particular in cases of FTFs classified as unstable fractures. Since the introduction of hip arthroplasty in femoral neck fractures there has been a reduction in complication rates, early mobilization and shorter hospital stays.
The primary objective of this project is to investigate if treatment with hip arthroplasty in unstable FTFs will increase the postoperative mobility, give a better general health outcome for the patient, better quality of life and reduce re-operation rate for the patients compared to those operated with the traditional IMN.
Read the detailed description
Proximal femoral fractures also termed "hip" fractures are one of the most common fractures among adults over 50 years of age. With increase in life expectancy, the incidence of these fractures is also increasing. By 2040, the number of these fractures are expected to double in Norway. Trochanteric fractures of the femur (Fractura Trochanterica Femoris, FTF) represents about 35% of the hip fractures in Norway . There are many classification systems for FTFs, but The Orthopaedic Trauma Association (OTA) have adopted the system developed by the Arbeitsgemeinschaft Osteosynthese (AO ) group, and is the most commonly used in addition to the Evans Jensens classification.
The mean age of hip fracture patients is 82 years for women and 78 for men. The comorbidity in this patient group is high with large amount of dementia, sarcopenia and osteoporosis. The one-year mortality rate after a hip fractures is 20-35%. According to the Norwegian Hip Fracture Register 15 % of the hip fractures are unstable trochanteric fractures (AO 31A2.2-A3). The prognosis is poor, in particular for unstable (multi fragmented) fractures, with reported complications up to 35-51 %.
Substantial research has established better understanding and best practice guidelines to treat the femoral neck fractures, mostly with hip arthroplasty, however no superior method is established for the unstable trochanteric fractures. 'Getting It Right First Time' is important for these fragile patients, thus post-operative complications are associated with a large increase in the mortality.
Today, most of the FTFs are reduced and fixated with a sliding hip screw (SHS), although the use of intramedullary nails (IMN) is increasing. RCTs have shown better survival of IMN compared to SHS for the more distal FTFs and subtrochanteric fracture. Unstable FTFs (AO 31A2 - A3, EVJ III-V) have high reoperation rates (21-35%) when operated either with SHS or IMN. Unacceptable shortening, external rotation deformity of the limb and long time to recover/mobilization have been the problems with osteosynthesis.
The question is if hip arthroplasty can give a superior treatment outcome for patients suffering from unstable subtypes of trochanteric hip fractures compared to the traditional treatment with IMN. A randomized clinical trial is to be conducted comparing these two treatment methodologies.
Stavanger University Hospital (SUH) receives over 150 FTFs per year. About 1/3 of the FTFs are of unstable fracture morphology. The planned study is a randomized clinical trial. The randomization module will be provided by Klinisk forskningsenhet Midt-Norge (KlinForsk). Patients fulfilling the inclusion criteria will be randomized to one of two treatment groups, IMN versus hip arthroplasty.
Included patients will be treated in accordance to a local operation protocol:
Intramedullary nails will be operated by a resident orthopedic surgeon with at least 2 years' experience in fracture surgery or a consultant orthopedic surgeon (there must always be a consultant orthopedic surgeon present in the surgical team). A long IMN must always be utilized. Anatomical reposition or positive anterior and medial cortical support should be strived to be achieved. If a large antero- or posteromedial fragment is present one should consider an additional cerclage to fix the fragment.
Arthroplasty will be operated by a resident orthopedic surgeon with at least 2 years' experience with hip arthroplasty surgery or by a consultant orthopedic surgeon subspecialized in arthroplasty surgery, with competency within revision or difficult primary hip arthroplasty surgery (there must always be a consultant orthopedic surgeon subspecialized in arthroplasty surgery present in the surgical team). Posterior surgical approach will be used. If a cup is to be utilized it must be a cemented dual-mobility cup.
The patients will have follow-up appointments at 2-, 6 and 12 months postoperative. Following data will be collected:
- Patient reported outcome measures (HOOS and EQ5D)
- Timed up and go test
- Trendelenburg test
- Clinical leg length discrepancy
- Radiological assessment from hip x-rays (AP and lateral)
- Conditions
- Hip Injuries and Disorders, Hip Fractures
- Being tested
- Intramedullary nail, Hip arthroplasty
- Keywords
- Trochanteric hip fracture, Unstable trochanteric hip fractures
- Medical subject headings
- Hip Injuries, Disease, Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intramedullary nailProcedure or surgery
Intertan nail (Smith \& Nephew)* or Gamma 3 nail (Stryker)*
- All of the above-mentioned products are subjects to change into an equivalent product
Hip arthroplastyProcedure or surgery
Total hip arthroplasty:
- Cemented: Lubinus (Link)*, Exeter (Stryker)*
- Uncemented: Restoration Modular (Stryker)*
- Cup: Cemented Avantage dual mobility cup (Zimmer Biomet)*
Hemiarthroplasty:
- Cemented: Lubinus (Link)*, Exeter (Stryker)*
- Uncemented: Restoration Modular (Stryker)*
- All of the above-mentioned products are subjects to change into an equivalent product
| Study group | Role | What they receive |
|---|---|---|
| Intramedullary nail | Active comparator | Intramedullary nail with proximal lagscrew and distal locking screw(s) Receives: Procedure: Intramedullary nail |
| Hip arthroplasty | Active comparator | Hemiarthroplasty (HA) or Total hip arthroplasty (THA). A cemented dual-mobility cup will be utilized in THA. Addition of cerclage/trochanter claw plate to fixate trochanter major will be used when suitable. Receives: Procedure: Hip arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Reported Outcome Measure (PROM)
Hip disability and Osteoarthritis Outcome Score (HOOS).
"HOOS is developed as an instrument to assess the patients' opinion about their hip and associated problems. HOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and hip related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. The result can be plotted as an outcome profile.
- Above information about HOOS is copied from the authors of www.KOOS.nu
- Change in HOOS score will be observed from 2-, 6- and 12 months.
Measured: Collected at 2, 6 and 12 months from primary surgery
Patient Reported Outcome Measure (PROM)
EuroQol EQ-5D.
"The descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the 5 dimensions can be combined into a 5-digit number that describes the patient's health state.
The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement."
Change in EQ-5D score will be observed from 2-, 6- and 12 months.
Measured: Collected from 2 to 12 months from primary surgery
Secondary outcomes (20)
Mortality
Mortality rates will be analyzed
Measured: 2, 6 and 12 months from primary surgery
Complications related to prosthesis
Specific complications related to the randomly assign intervention;
- Peri prosthesis fracture
- Prosthesis dislocation
- Prosthesis loosening
- Dislocation of trochanter major
- Surgical wound infection (superficial)
- Deep surgical wound infection
Measured: Collected from 2 to 12 months from primary surgery
Complications related to osteosynthesis
Specific complications related to the randomly assign intervention;
- Peri implant fracture (intraoperative or postoperative)
- Implant cut-out
- Non-union of fracture
- Dislocation of trochanter major
- Surgical wound infection (superficial)
- Deep surgical wound infection
Measured: Collected from 2 to 12 months from primary surgery
Somatic postoperative complications
- Deep vein thrombosis or other thromboembolic event
- Pressure sores
- Neurological complications
- Other
Measured: Collected from 2 to 12 months from primary surgery
Reoperation rate
Reoperation rate (and causes) within each intervention arm
Measured: Collected at 2, 6 and 12 months from primary surgery
Radiological assessment of horizontal center of rotation (prosthesis)
Horizontal center of rotation (millimeter)
Observation for eventual changes in above mentioned variable will be recorded throughout three follow-up appointments.
Measured: Collected at 2, 6 and 12 months from primary surgery
Radiological assessment of vertical center of rotation (prosthesis)
Vertical center of rotation (millimeter)
Observation for eventual changes in above mentioned variable will be recorded throughout three follow-up appointments.
Measured: Collected at 2, 6 and 12 months from primary surgery
Radiological assessment of acetabular inclination (prosthesis)
Acetabular inclination (degrees)
Observation for eventual changes in above mentioned variable will be recorded throughout three follow-up appointments.
Measured: Collected at 2, 6 and 12 months from primary surgery
Radiological assessment of acetabular anteversion (prosthesis)
Acetabular anteversion (degrees)
Observation for eventual changes in above mentioned variable will be recorded throughout three follow-up appointments.
Measured: Collected at 2, 6 and 12 months from primary surgery
Radiological assessment of femoral stem positioning (prosthesis)
Femoral stem positioning (valgus, neutral, varus)
Observation for eventual changes in above mentioned variable will be recorded throughout three follow-up appointments.
Measured: Collected at 2, 6 and 12 months from primary surgery
Radiological assessment of leg length discrepancy (intramedullary nail)
Leg length discrepancy (millimeter)
Observation for eventual changes in above mentioned variable will be recorded throughout three follow-up appointments.
Measured: Collected at 2, 6 and 12 months from primary surgery
Radiological assessment of femoral neck length (intramedullary nail)
Femoral neck length (millimeter)
Observation for eventual changes in above mentioned variable will be recorded throughout three follow-up appointments.
Measured: Collected at 2, 6 and 12 months from primary surgery
Radiological assessment of hip offset (intramedullary nail)
Hip offset (millimeter)
Observation for eventual changes in above mentioned variable will be recorded throughout three follow-up appointments.
Measured: Collected at 2, 6 and 12 months from primary surgery
Radiological assessment of tip-to-apex (intramedullary nail)
Tip-to-Apex (millimeter)
Observation for eventual changes in above mentioned variable will be recorded throughout three follow-up appointments.
Measured: Collected at 2, 6 and 12 months from primary surgery
Radiological assessment of medial cortical support (intramedullary nail)
Medial cortical support (negativ, neutral or positive)
Observation for eventual changes in above mentioned variable will be recorded throughout three follow-up appointments.
Measured: Collected at 2, 6 and 12 months from primary surgery
Radiological assessment of anterior cortical support (intramedullary nail)
Anterior cortical support (negativ, neutral or positive)
Observation for eventual changes in above mentioned variable will be recorded throughout three follow-up appointments.
Measured: Collected at 2, 6 and 12 months from primary surgery
Radiological assessment of trochanter major dislocation (intramedullary nail)
Trochanter major dislocation (millimeter)
Observation for eventual changes in above mentioned variable will be recorded throughout three follow-up appointments.
Measured: Collected at 2, 6 and 12 months from primary surgery
Timed Up and Go test (TUG test)
Timed Up and Go test is used to asses mobility at follow-up 2-, 6- and 12 months postoperative.
Observation for eventual changes in above mentioned variable will be recorded throughout three follow-up appointments.
Measured: Collected at 2, 6 and 12 months from primary surgery
Trendelenburg test
Trendelenburg test is used to assess hip abductor function at follow-up 2-, 6- and 12 months postoperative.
Measured: Collected at 2, 6 and 12 months from primary surgery
Clinical leg length discrepancy
Clinical assessment of leg length discrepancy using 5 mm plates.
Observation for eventual changes in above mentioned variable will be recorded throughout three follow-up appointments.
Measured: Collected at 2, 6 and 12 months from primary surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2021
- Study start12 Oct 2021
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip Injuries and DisordersStudies 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
- Model description
- Patients with an identified unstable trochanteric hip fracture (AO 31A2.2-3.3) who has fulfilled inclusion criteria and given their consent will be randomized into one of two treatments; Intramedullary nail versus hip arthroplasty
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helse Stavanger HF
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ane Djuv, MD., PhD, Principal investigator, Helse Stavanger HFJan-Erik Gjertsen, MD., PhD, Study chair, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04868305
- Sponsor's protocol ID
- 140120V1
- Acronym
- TUFHIPRCT
- Status last verified
- Apr 2026
- First submitted
- 6 Apr 2021
- Last updated
- 30 Apr 2026
- 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 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial: Treatment of Unstable Trochanteric Hip Fractures With Intramedullary Nail Versus Hip Arthroplasty: Survival, Complications and Postoperative Patient Reported Outcomes
- ClinicalTrials.gov ID
- NCT04868305
- Acronym / sponsor ID
- TUFHIPRCT / 140120V1
- Conditions
- Hip Injuries and Disorders, Hip Fractures
- Keywords
- Trochanteric hip fracture, Unstable trochanteric hip fractures
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Helse Stavanger HFOther government
- Study start
- 12 Oct 2021 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 30 Apr 2021 (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.
A hip fracture is a large burden to the patient with increased mortality, pain and increased need for daily assistance. Trochanteric fractures of the femur (FTF) represents about 35% of the hip fractures. Today FTFs are mainly treated with internal fixation using sliding hips screws (SHS) or intramedullary nail (IMN), whilst hip arthroplasty (THA/HA) is rarely used. Despite advances in the design of the internal fixation implants there is a high failure rate, in particular in cases of FTFs classified as unstable fractures. Since the introduction of hip arthroplasty in femoral neck fractures there has been a reduction in complication rates, early mobilization and shorter hospital stays.
The primary objective of this project is to investigate if treatment with hip arthroplasty in unstable FTFs will increase the postoperative mobility, give a better general health outcome for the patient, better quality of life and reduce re-operation rate for the patients compared to those operated with the traditional IMN.
Detailed description
Proximal femoral fractures also termed "hip" fractures are one of the most common fractures among adults over 50 years of age. With increase in life expectancy, the incidence of these fractures is also increasing. By 2040, the number of these fractures are expected to double in Norway. Trochanteric fractures of the femur (Fractura Trochanterica Femoris, FTF) represents about 35% of the hip fractures in Norway . There are many classification systems for FTFs, but The Orthopaedic Trauma Association (OTA) have adopted the system developed by the Arbeitsgemeinschaft Osteosynthese (AO ) group, and is the most commonly used in addition to the Evans Jensens classification.
The mean age of hip fracture patients is 82 years for women and 78 for men. The comorbidity in this patient group is high with large amount of dementia, sarcopenia and osteoporosis. The one-year mortality rate after a hip fractures is 20-35%. According to the Norwegian Hip Fracture Register 15 % of the hip fractures are unstable trochanteric fractures (AO 31A2.2-A3). The prognosis is poor, in particular for unstable (multi fragmented) fractures, with reported complications up to 35-51 %.
Substantial research has established better understanding and best practice guidelines to treat the femoral neck fractures, mostly with hip arthroplasty, however no superior method is established for the unstable trochanteric fractures. 'Getting It Right First Time' is important for these fragile patients, thus post-operative complications are associated with a large increase in the mortality.
Today, most of the FTFs are reduced and fixated with a sliding hip screw (SHS), although the use of intramedullary nails (IMN) is increasing. RCTs have shown better survival of IMN compared to SHS for the more distal FTFs and subtrochanteric fracture. Unstable FTFs (AO 31A2 - A3, EVJ III-V) have high reoperation rates (21-35%) when operated either with SHS or IMN. Unacceptable shortening, external rotation deformity of the limb and long time to recover/mobilization have been the problems with osteosynthesis.
The question is if hip arthroplasty can give a superior treatment outcome for patients suffering from unstable subtypes of trochanteric hip fractures compared to the traditional treatment with IMN. A randomized clinical trial is to be conducted comparing these two treatment methodologies.
Stavanger University Hospital (SUH) receives over 150 FTFs per year. About 1/3 of the FTFs are of unstable fracture morphology. The planned study is a randomized clinical trial. The randomization module will be provided by Klinisk forskningsenhet Midt-Norge (KlinForsk). Patients fulfilling the inclusion criteria will be randomized to one of two treatment groups, IMN versus hip arthroplasty.
Included patients will be treated in accordance to a local operation protocol:
Intramedullary nails will be operated by a resident orthopedic surgeon with at least 2 years' experience in fracture surgery or a consultant orthopedic surgeon (there must always be a consultant orthopedic surgeon present in the surgical team). A long IMN must always be utilized. Anatomical reposition or positive anterior and medial cortical support should be strived to be achieved. If a large antero- or posteromedial fragment is present one should consider an additional cerclage to fix the fragment.
Arthroplasty will be operated by a resident orthopedic surgeon with at least 2 years' experience with hip arthroplasty surgery or by a consultant orthopedic surgeon subspecialized in arthroplasty surgery, with competency within revision or difficult primary hip arthroplasty surgery (there must always be a consultant orthopedic surgeon subspecialized in arthroplasty surgery present in the surgical team). Posterior surgical approach will be used. If a cup is to be utilized it must be a cemented dual-mobility cup.
The patients will have follow-up appointments at 2-, 6 and 12 months postoperative. Following data will be collected:
- Patient reported outcome measures (HOOS and EQ5D)
- Timed up and go test
- Trendelenburg test
- Clinical leg length discrepancy
- Radiological assessment from hip x-rays (AP and lateral)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients with an identified unstable trochanteric hip fracture (AO 31A2.2-3.3) who has fulfilled inclusion criteria and given their consent will be randomized into one of two treatments; Intramedullary nail versus hip arthroplasty
| Arm | Type | Receives |
|---|---|---|
| Intramedullary nail | Active comparator | Procedure: Intramedullary nailIntramedullary nail with proximal lagscrew and distal locking screw(s) |
| Hip arthroplasty | Active comparator | Procedure: Hip arthroplastyHemiarthroplasty (HA) or Total hip arthroplasty (THA). A cemented dual-mobility cup will be utilized in THA. Addition of cerclage/trochanter claw plate to fixate trochanter major will be used when suitable. |
Who may qualify
- Ages
- 65 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Age ≥ 65 years
- American Society of Anesthesiology Score (ASA) < 4
- Ambulant with or without aid (preinjury)
- Radiological verified unstable trochanteric hip fracture (AO 31A2.2 - 3.3)
- Written consent obtained by patient or his/her next of kin
Key exclusion criteria (3 listed)
- Previous hip surgery on ipsilateral or contralateral side
- Non-ambulant preinjury
- Patient not living in the area of hospital care
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 |
|---|---|---|
| Intramedullary nailIntertan nail (Smith \& Nephew)* or Gamma 3 nail (Stryker)* * All of the above-mentioned products are subjects to change into an equivalent product | Procedure or surgery | Intramedullary nail |
| Hip arthroplastyTotal hip arthroplasty: * Cemented: Lubinus (Link)*, Exeter (Stryker)* * Uncemented: Restoration Modular (Stryker)* * Cup: Cemented Avantage dual mobility cup (Zimmer Biomet)* Hemiarthroplasty: * Cemented: Lubinus (Link)*, Exeter (Stryker)* * Uncemented: Restoration Modular (Stryker)* * All of the above-mentioned products are subjects to change into an equivalent product | Procedure or surgery | Hip arthroplasty |
Primary outcome
Patient Reported Outcome Measure (PROM)
Time frame: Collected at 2, 6 and 12 months from primary surgery
Hip disability and Osteoarthritis Outcome Score (HOOS). "HOOS is developed as an instrument to assess the patients' opinion about their hip and associated problems. HOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and hip related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. The result can be plotted as an outcome profile. * Above information about HOOS is copied from the authors of www.KOOS.nu * Change in HOOS score will be observed from 2-, 6- and 12 months.
Patient Reported Outcome Measure (PROM)
Time frame: Collected from 2 to 12 months from primary surgery
EuroQol EQ-5D. "The descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the 5 dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement." Change in EQ-5D score will be observed from 2-, 6- and 12 months.
20 secondary outcomes
Mortality
Time frame: 2, 6 and 12 months from primary surgery
Complications related to prosthesis
Time frame: Collected from 2 to 12 months from primary surgery
Complications related to osteosynthesis
Time frame: Collected from 2 to 12 months from primary surgery
Somatic postoperative complications
Time frame: Collected from 2 to 12 months from primary surgery
Reoperation rate
Time frame: Collected at 2, 6 and 12 months from primary surgery
Radiological assessment of horizontal center of rotation (prosthesis)
Time frame: Collected at 2, 6 and 12 months from primary surgery
Radiological assessment of vertical center of rotation (prosthesis)
Time frame: Collected at 2, 6 and 12 months from primary surgery
Radiological assessment of acetabular inclination (prosthesis)
Time frame: Collected at 2, 6 and 12 months from primary surgery
Radiological assessment of acetabular anteversion (prosthesis)
Time frame: Collected at 2, 6 and 12 months from primary surgery
Radiological assessment of femoral stem positioning (prosthesis)
Time frame: Collected at 2, 6 and 12 months from primary surgery
Radiological assessment of leg length discrepancy (intramedullary nail)
Time frame: Collected at 2, 6 and 12 months from primary surgery
Radiological assessment of femoral neck length (intramedullary nail)
Time frame: Collected at 2, 6 and 12 months from primary surgery
Radiological assessment of hip offset (intramedullary nail)
Time frame: Collected at 2, 6 and 12 months from primary surgery
Radiological assessment of tip-to-apex (intramedullary nail)
Time frame: Collected at 2, 6 and 12 months from primary surgery
Radiological assessment of medial cortical support (intramedullary nail)
Time frame: Collected at 2, 6 and 12 months from primary surgery
Radiological assessment of anterior cortical support (intramedullary nail)
Time frame: Collected at 2, 6 and 12 months from primary surgery
Radiological assessment of trochanter major dislocation (intramedullary nail)
Time frame: Collected at 2, 6 and 12 months from primary surgery
Timed Up and Go test (TUG test)
Time frame: Collected at 2, 6 and 12 months from primary surgery
Trendelenburg test
Time frame: Collected at 2, 6 and 12 months from primary surgery
Clinical leg length discrepancy
Time frame: Collected at 2, 6 and 12 months from primary surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Hip Injuries and Disorders
Recruiting
SIRI Levels Following PENG Block in Pediatric Hip Surgery
Hip Dysplasia
RecruitingPhase 4
PENG With LFCB vs. ESP Blocks for Pediatric Hip Surgery
Hip Disease, Hip Dysplasia
Enrolling by invitationObservational study
GRACE II (General Retrospective Analysis of Commercial Experience With AGN1 LOEP)
Osteoporosis
Not yet recruitingPhase 4
Suzetrigine (Journavx) as Multimodal Therapy for Pain Management in Adults Undergoing Surgery for Hip Fracture
Hip Fractures (ICD-10 72.01-72.2), Post Operative Analgesia
Not yet recruiting
Posterior Pericapsular Deep-gluteal Block
Pain, Postoperative
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.
Ane Djuv, MD., PhD principal investigator
Helse Stavanger HF
Jan-Erik Gjertsen, MD., PhD study chair
Haukeland University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intramedullary nail and Hip arthroplasty in people with Hip Injuries and Disorders and Hip Fractures, run by Helse Stavanger HF at 1 site 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 5 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas Abel Woldeyesus, MD (+4751513488, thomas.abel.woldeyesus@sus.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Reported Outcome Measure (PROM) (time frame: Collected at 2, 6 and 12 months from primary surgery). The study lists 2 primary outcomes in all. 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 30 Apr 2026.