Clinical trial NCT04075461: Arthroplasty Versus Internal Fixation for Undisplaced Femoral Neck Fracture
Official title: Is arthroplaSty bEtter Than interNal Fixation in the undiSplaced Femoral nEck Fracture? A National Pragmatical Randomized Controlled Trial - the SENSE Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Undisplaced Fracture
Femoral Neck Fractures
Internal Fixation; Complications
Arthroplasty Complications
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Aalborg University Hospital
name: Regionshospital Nordjylland
name: Aarhus University Hospital
name: Odense University Hospital
name: Slagelse Hospital
name: Bispebjerg Hospital
name: Regionshospitalet Viborg, Skive
name: Randers Regional Hospital
name: Regionshospitalet Horsens
name: Hospital of Southern Jutland
name: Esbjerg Hospital - University Hospital of Southern Denmark
name: Hvidovre University Hospital
name: Herlev Hospital
name: Hillerod Hospital, Denmark
name: Holbaek Sygehus
name: Zealand University Hospital
name: Sygehus Lillebaelt
name: Nykøbing Falster County Hospital
name: Regional Hospital West Jutland
name: Bornholm Hospital
First posted: 2019-08-30
Enrollment: 330
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is designed as a national pragmatical RCT including all patients with an undisplaced FNF and a NMS score of 5 and above. The standard treatment in Denmark is internal fixation and the patients are randomized to arthroplasty or IF. The steering group have assessed the pragmatic attitude of the design and the study reaches 5 points in 7 of the 9 domains (Figure 1) (9). Reporting is performed accordingly to the extension of the CONSORT statements for pragmatical RCT (17). Using the PRECIS-2 we scored the study to 43 points out of 45 possible.
Primary purpose: TREATMENT

Brief summary: This is the world's first national orthopedic randomized controlled trial (RCT) involving 19 out of 21 departments in Denmark. Each year, 7,000 patients suffer a hip fracture. This is a severe condition leading to 25% mortality after 1 year and 40% do not recover to the same functional level. The aim is to compare two surgical treatment methods (metal fixation versus artificial hip) in patients above 65 years with an undisplaced femoral neck fracture. The hypothesis is that even though an artificial hip is a larger surgical procedure than metal fixation of the broken bone, the artificial hip is more stable with less pain due the lack of a healing broken bone and therefore leads to a better and quicker mobilization after surgery. Better mobilization is one of the most important factors for decreasing mortality. We have chosen a pragmatic RCT design by using the local departmental implants. We hope that the knowledge from this study will therefore easily be implemented afterwards.

Detailed description: This is the world's first national orthopedic randomized controlled trial (RCT) involving 20 out of 21 departments in Denmark. The aim is to compare two surgical treatment methods (internal fixation (IF) versus arthroplasty) in patients above 65 years with an undisplaced femoral neck fracture (FNF).

Each year, 7,000 patients suffer a hip fracture. This is a severe condition leading to 25% mortality after 1 year and 40% do not recover to the same functional level. Undisplaced FNF is treated with internal fixation in order to aid in fracture healing. However, approximately 10% in Denmark will suffer a reoperation and two RCT's have demonstrated 20-21% reoperations. In comparison, the reoperation frequency was 5-7% for arthroplasty that also demonstrated slightly faster mobilization which is one of the most important factors for decreasing mortality. The hypothesis is therefore that even though arthroplasty is a larger surgery they benefit from the lack of fracture healing, less pain and faster mobilization.

Patients are included in the emergency department and are electronically randomized to either IF or arthroplasty before the surgery. The design is a pragmatic RCT using the implants which are available in the departments. Furthermore, the postoperative treatment protocol is "business as usual" thereby investigating the precise effect of the intervention in real clinical conditions. In addition to a great external validity this allows for easy implemented after study results. The primary outcome is a validated functional score 1 year after surgery and the sample size is calculated to 330 patients. Secondary outcome measures are additional functional assessments and questionnaires, health related quality of life and pain assessment.

We have set up a steering committee consisting of researchers and senior surgeons with a representative from each region. In addition, all but 1 hospital has a representative in project group. The project is therefore anchored in the entire Denmark.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 65 years old
* Undisplaced femoral neck fracture
* Posterior tilt (18) less than 20 degrees
* NMS (13) = 5 and above, indicating an ability to walk
* Cognitive intact in order to achieve informed consent

Exclusion Criteria:

* The fracture is pathological
* The patient does not speak Danish

Primary outcomes:
measure: New Mobility Score (NMS)
timeFrame: 12 months
Secondary outcomes:
measure: EuroQol 5 domain 5 level (EQ-5D-5L)
timeFrame: Admission, 3 months, 6 months and 12 months.
measure: Oxford Hip Score (OHS)
timeFrame: Admission, 3 months, 6 months and 12 months.
measure: Reoperation
timeFrame: Within 1 year after surgery
measure: Mortality
timeFrame: Within 1 year after surgery
measure: New Mobility Score (NMS)
timeFrame: Admission, 3 and 6 months
measure: Pain Verbal Rating Scale (VRS)
timeFrame: Admission, 2 and 6 weeks, 3, 6, and 12 months
Other outcomes:
measure: New Mobility Score (NMS)
timeFrame: 2 and 5 years
measure: EuroQol 5 domain 5 level (EQ-5D-5L)
timeFrame: 2 and 5 years
measure: Reoperation
timeFrame: 2 and 5 years
measure: Mortality
timeFrame: 2 and 5 years
measure: Pain Verbal Rating Scale (VRS)
timeFrame: 2 and 5 years
measure: Oxford Hip Score (OHS)
timeFrame: 2 and 5 years
measure: de Morton Mobility Index (DEMMI)
timeFrame: Admission, 3 months, 6 months, 12 months, 2 and 5 years
measure: Barthel-20
timeFrame: Admission, 3 months, 6 months, 12 months, 2 and 5 years
measure: Cumulated Cumulated Ambulation Score (CAS)
timeFrame: Admission, 6 and 12 weeks
measure: X-ray measurement 1
timeFrame: First postoperative x-ray during admission and 1 year
Locations:
city: Aabenraa
country: Denmark
facility: Hospital of Southern Jutland
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
city: Copenhagen
country: Denmark
facility: Herlev Hospital
city: Copenhagen
country: Denmark
facility: Hvidovre Hospital
city: Gødstrup
country: Denmark
facility: Regional Hospital West Jutland
city: Hillerød
country: Denmark
facility: Hospital of North Zealand
city: Hjørring
country: Denmark
facility: North Denmark Regional Hospital
city: Holbæk
country: Denmark
facility: Holbæk Hospital
city: Horsens
country: Denmark
facility: Randers Regional Hospital
city: Kolding
country: Denmark
facility: Lillebaelt Hospital
city: Køge
country: Denmark
facility: Zealand University Hospital
city: Nykøbing Falster
country: Denmark
facility: Nykøbing Falster Hospital
city: Odense
country: Denmark
facility: Odense University Hospital
city: Randers
country: Denmark
facility: Randers Regional Hospital
city: Rønne
country: Denmark
facility: Bornholm Hospital
city: Slagelse
country: Denmark
facility: Slagelse Hospital
city: Viborg
country: Denmark
facility: Viborg Regional Hospital
Study officials:
affiliation: Department of Orthopaedic Surgery and Traumatology, Lillebaelt Hospital
name: Bjarke Viberg, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Orthopaedic Surgery and Traumatology, Aarhus University Hospital
name: Ole Brink, MD, PhD
role: STUDY_CHAIR
affiliation: Department of Orthopaedic Surgery and Traumatology, Aalborg University Hospital
name: Søren Kold, Professor
role: STUDY_CHAIR
affiliation: Odense University Hospital
name: Morten S Larsen, MD
role: STUDY_CHAIR
affiliation: Department of Orthopaedic Surgery and Traumatology, Slagelse Hospital
name: Kristoffer B Hare, MD, PhD
role: STUDY_CHAIR
affiliation: Department of Orthopaedic Surgery and Traumatology, Bispebjerg Hospital
name: Henrik Palm, MD, DmSc
role: STUDY_CHAIR
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