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SENSE: Arthroplasty Versus Internal Fixation for Undisplaced Femoral Neck Fracture

Sponsor
University of Southern Denmark (Other)
Overall Status
Recruiting
CT.gov ID
NCT04075461
Collaborator
Aalborg University Hospital (Other), North Denmark Regional Hospital (Other), Aarhus University Hospital (Other), Odense University Hospital (Other), Slagelse Hospital (Other), Bispebjerg Hospital (Other), Regionshospitalet Viborg, Skive (Other), Randers Regional Hospital (Other), Regionshospitalet Horsens (Other), Hospital of Southern Jutland (Other), Hospital of South West Jutland (Other), Hvidovre University Hospital (Other), Herlev Hospital (Other), Hillerod Hospital, Denmark (Other), Holbaek Sygehus (Other), Zealand University Hospital (Other), Sygehus Lillebaelt (Other), Nykøbing Falster County Hospital (Other), Regional Hospital West Jutland (Other), Bornholm Hospital (Other)
330
Enrollment
19
Locations
2
Arms
91.9
Anticipated Duration (Months)
17.4
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Arthroplasty
  • Procedure: Internal fixation
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
330 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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.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.
Masking:
Single (Outcomes Assessor)
Masking Description:
The surgeon, theater staff and patient cannot be blinded due to the nature of two very different types of surgery. However, the assessors will be blinded for type of surgery.
Primary Purpose:
Treatment
Official Title:
Is arthroplaSty bEtter Than interNal Fixation in the undiSplaced Femoral nEck Fracture? A National Pragmatical Randomized Controlled Trial - the SENSE Trial
Actual Study Start Date :
Feb 1, 2020
Anticipated Primary Completion Date :
Sep 30, 2023
Anticipated Study Completion Date :
Sep 30, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: Undisplaced FNF + Arthroplasty

Arthroplasty is the typical surgery for a displaced femoral neck fracture

Procedure: Arthroplasty
Arthroplasty is commonly used for a displaced femoral neck fracture.
Active Comparator: Undisplaced FNF + Internal fixation

Internal fixation is the typical surgery for an undisplaced femoral neck fracture

Procedure: Internal fixation
Internal fixation is commonly used for undisplaced femoral neck fracture

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

  2. 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.

  3. Reoperation [Within 1 year after surgery]

    New surgery in relation to the primary surgery

  4. Mortality [Within 1 year after surgery]

    Mortality

  5. 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.

  6. Pain Verbal Rating Scale (VRS) [Admission, 2 and 6 weeks, 3, 6, and 12 months]

    Patient reported outcome of pain assessment

Other Outcome Measures

  1. New Mobility Score (NMS) [2 and 5 years]

    NMS score the level of function with a score from 0-9 points. The best score is 9 points.

  2. EuroQol 5 domain 5 level (EQ-5D-5L) [2 and 5 years]

    Health related quality of life assessment with a score from 0-1 point. The best score is 1

  3. Reoperation [2 and 5 years]

    New surgery in relation to the primary surgery, given in numbers and percentage

  4. Mortality [2 and 5 years]

    Mortality given in number of deaths and percentage

  5. Pain Verbal Rating Scale (VRS) [2 and 5 years]

    Patient reported outcome of pain assessment of pain from 1 to 10

  6. Oxford Hip Score (OHS) [2 and 5 years]

    Specific hip function questionnaire with a score from 0-48 points. The best score is 48 points.

  7. de Morton Mobility Index (DEMMI) [Admission, 3 months, 6 months, 12 months, 2 and 5 years]

    Mobility index with a score from 0-100 points. The best score is 100 points

  8. Barthel-20 [Admission, 3 months, 6 months, 12 months, 2 and 5 years]

    Index for activities of daily living with a score from 0-20 points. The best score is 20 points.

  9. Cumulated Cumulated Ambulation Score (CAS) [Admission, 6 and 12 weeks]

    Basic mobility score with a score from 0-6 points. The best score is 6 points.

  10. X-ray measurement 1 [First postoperative x-ray during admission and 1 year]

    Quality of implant positioning (IMPO) score with a score from 0-6 point. The best score is 6 points

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital of Southern Jutland Aabenraa Denmark
2 Aalborg University Hospital Aalborg Denmark
3 Aarhus University Hospital Aarhus Denmark
4 Bispebjerg Hospital Copenhagen Denmark
5 Herlev Hospital Copenhagen Denmark
6 Hvidovre Hospital Copenhagen Denmark
7 Regional Hospital West Jutland Gødstrup Denmark
8 Hospital of North Zealand Hillerød Denmark
9 North Denmark Regional Hospital Hjørring Denmark
10 Holbæk Hospital Holbæk Denmark
11 Randers Regional Hospital Horsens Denmark
12 Lillebaelt Hospital Kolding Denmark 6000
13 Zealand University Hospital Køge Denmark
14 Nykøbing Falster Hospital Nykøbing Falster Denmark
15 Odense University Hospital Odense Denmark
16 Randers Regional Hospital Randers Denmark
17 Bornholm Hospital Rønne Denmark
18 Slagelse Hospital Slagelse Denmark 4200
19 Viborg Regional Hospital Viborg Denmark

Sponsors and Collaborators

  • University of Southern Denmark
  • Aalborg University Hospital
  • North Denmark Regional Hospital
  • Aarhus University Hospital
  • Odense University Hospital
  • Slagelse Hospital
  • Bispebjerg Hospital
  • Regionshospitalet Viborg, Skive
  • Randers Regional Hospital
  • Regionshospitalet Horsens
  • Hospital of Southern Jutland
  • Hospital of South West Jutland
  • Hvidovre University Hospital
  • Herlev Hospital
  • Hillerod Hospital, Denmark
  • Holbaek Sygehus
  • Zealand University Hospital
  • Sygehus Lillebaelt
  • Nykøbing Falster County Hospital
  • Regional Hospital West Jutland
  • Bornholm Hospital

Investigators

  • Principal Investigator: Bjarke Viberg, MD, PhD, Department of Orthopaedic Surgery and Traumatology, Lillebaelt Hospital
  • Study Chair: Ole Brink, MD, PhD, Department of Orthopaedic Surgery and Traumatology, Aarhus University Hospital
  • Study Chair: Søren Kold, Professor, Department of Orthopaedic Surgery and Traumatology, Aalborg University Hospital
  • Study Chair: Morten S Larsen, MD, Odense University Hospital
  • Study Chair: Kristoffer B Hare, MD, PhD, Department of Orthopaedic Surgery and Traumatology, Slagelse Hospital
  • Study Chair: Henrik Palm, MD, DmSc, Department of Orthopaedic Surgery and Traumatology, Bispebjerg Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University of Southern Denmark
ClinicalTrials.gov Identifier:
NCT04075461
Other Study ID Numbers:
  • S-20180036
First Posted:
Aug 30, 2019
Last Update Posted:
Jun 7, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Fractures, Bone
Femoral Neck Fractures

Study Results

No Results Posted as of Jun 7, 2022