Arthroplasty Versus Internal Fixation for Undisplaced Femoral Neck Fracture
- Conditions
- Femoral Neck FracturesUndisplaced FractureInternal Fixation; ComplicationsArthroplasty Complications
- Interventions
- Procedure: ArthroplastyProcedure: Internal fixation
- Registration Number
- NCT04075461
- Lead Sponsor
- University of Southern Denmark
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 330
- 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
- The fracture is pathological
- The patient does not speak Danish
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Undisplaced FNF + Arthroplasty Arthroplasty Arthroplasty is the typical surgery for a displaced femoral neck fracture Undisplaced FNF + Internal fixation Internal fixation Internal fixation is the typical surgery for an undisplaced femoral neck fracture
- Primary Outcome Measures
Name Time Method New Mobility Score (NMS) 12 months NMS score the level of function with a score from 0-9 points. The best score is 9 points.
- Secondary Outcome Measures
Name Time Method Mortality Within 1 year after surgery Mortality
EuroQol 5 domain 5 level (EQ-5D-5L) Admission, 3 months, 6 months and 12 months. Health related quality of life assessment with a score from 0-1 point. The best score is 1 point
Reoperation Within 1 year after surgery New surgery in relation to the primary surgery
Pain Verbal Rating Scale (VRS) Admission, 2 and 6 weeks, 3, 6, and 12 months Patient reported outcome of pain assessment
Oxford Hip Score (OHS) Admission, 3 months, 6 months and 12 months. Specific hip function questionnaire with a score from 0-48 points. The best score is 48 points.
New Mobility Score (NMS) Admission, 3 and 6 months NMS score the level of function with a score from 0-9 points. The best score is 9 points.
Trial Locations
- Locations (18)
Bispebjerg Hospital
🇩🇰Copenhagen, Denmark
Randers Regional Hospital
🇩🇰Randers, Denmark
Slagelse Hospital
🇩🇰Slagelse, Denmark
Nykøbing Falster Hospital
🇩🇰Nykøbing Falster, Denmark
Hospital of Southern Jutland
🇩🇰Aabenraa, Denmark
Aalborg University Hospital
🇩🇰Aalborg, Denmark
Aarhus University Hospital
🇩🇰Aarhus, Denmark
Hvidovre Hospital
🇩🇰Copenhagen, Denmark
North Denmark Regional Hospital
🇩🇰Hjørring, Denmark
Regional Hospital West Jutland
🇩🇰Gødstrup, Denmark
Herlev Hospital
🇩🇰Copenhagen, Denmark
Hospital of North Zealand
🇩🇰Hillerød, Denmark
Holbæk Hospital
🇩🇰Holbæk, Denmark
Lillebaelt Hospital
🇩🇰Kolding, Denmark
Zealand University Hospital
🇩🇰Køge, Denmark
Bornholm Hospital
🇩🇰Rønne, Denmark
Odense University Hospital
🇩🇰Odense, Denmark
Viborg Regional Hospital
🇩🇰Viborg, Denmark