Hips Screws or (Total) Hip Replacement for Undisplaced Femoral Neck Fractures in Elderly Patients (HipSTHeR)

Sponsor

Uppsala University (Other)

Overall Status

Recruiting

CT.gov ID

NCT03966716

Collaborator

The Swedish Research Council (Other)

1,440

Enrollment

Locations

Arms

71.5

Anticipated Duration (Months)

57.6

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A registerbased RCT will investigate whether arthroplasty can decrease the reoperation rate compared to internal fixation for patients with an undisplaced femoral neck fracture (Garden I-II).

Condition or Disease	Intervention/Treatment	Phase
Femoral Neck Fractures Undisplaced Fracture	Device: Arthroplasty Device: Internal Fixation	N/A

Detailed Description

The aim of this study is to determine whether the treatment of elderly patients with an undisplaced femoral neck fracture (uFNF) can be improved by decreasing reoperation rates through replacing the hip instead of trying to preserve it. Patients ≥75 years with an uFNF will be included and randomized within the Swedish Fracture Register (SFR) platform to internal fixation (screws/pins) or arthroplasty (choice of hemi or total is at the surgeon's discretion). The primary outcome will be a composite variable that combines two variables (reoperations and mortality) into a single variable.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1440 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

HipSTHeR - a Registerbased Randomized Controlled Trial - Hip Screws or (Total) Hip Replacement for Undisplaced Femoral Neck Fractures in Elderly Patients.

Actual Study Start Date :

Sep 16, 2019

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Sep 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arthroplasty Arthroplasty, hemi or total depending on patient characteristics and surgeon's choice	Device: Arthroplasty Patients with an undisplaced femoral neck fracture receive a hemi or total hip arthroplasty depending on each hospital's routine for patient age and mobility.
Active Comparator: Internal Fixation Internal fixation with 2-3 screws or pins, or sliding hip screw device, depending on each hospital's routine	Device: Internal Fixation Patients with an undisplaced femoral neck fracture undergo a closed reduction and internal fixation with 2-3 screws or pins, or sliding hip screw device. Type of fixation depends on each hospital's routine.

Arm

Intervention/Treatment

Experimental: Arthroplasty

Arthroplasty, hemi or total depending on patient characteristics and surgeon's choice

Device: Arthroplasty

Patients with an undisplaced femoral neck fracture receive a hemi or total hip arthroplasty depending on each hospital's routine for patient age and mobility.

Active Comparator: Internal Fixation

Internal fixation with 2-3 screws or pins, or sliding hip screw device, depending on each hospital's routine

Device: Internal Fixation

Patients with an undisplaced femoral neck fracture undergo a closed reduction and internal fixation with 2-3 screws or pins, or sliding hip screw device. Type of fixation depends on each hospital's routine.

Outcome Measures

Primary Outcome Measures

Composite variable comprising reoperation rate and mortality [1 to 2-year post-surgery]
Both Death and mortality will be accounted for

Secondary Outcome Measures

Reoperation rate [2-year post-surgery]
Minor and major reoperations will be noted
Long-term Mortality [2-year post-surgery]
All deaths are recorded
Short-term Mortality [30 day mortality]
All deaths are recorded
Patient reported outcome: SMFA [1-year post surgery]
Short Musculoskeletal Functional Assessment (SMFA) questionnaire, will be routinely collected within the Swedish Fracture Register 1 year after the injury and compared with the results obtained by recall technique at the time of the fracture.

Other Outcome Measures

Occurrence of adverse events. [1-year post-surgery]
Adverse events, such as pulmonary embolism, infection, dislocation, myocardial infarction and stroke will be noted.
Long-term reoperation rate [5 and 10 years post-surgery]
Minor and major reoperations will be noted
External validity [2-year post-surgery]
Assessment of eligible patients not included in the study

Eligibility Criteria

Criteria

Ages Eligible for Study:

75 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Undisplaced (Garden I-II) femoral neck fracture (within 72h)
treated at participating unit
informed consent
amenable for both treatment options

Exclusion Criteria:

no informed consent
pathological or stress fracture
peri-implant fracture

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Uppsala University Hospital	Uppsala	Uppsala Lan	Sweden	75185
2	Alingsås Hospital	Alingsås		Sweden
3	Borås Hospital	Borås		Sweden
4	Falu Hospital	Falun		Sweden
5	Sahlgrenska university Hospital	Gothenburg		Sweden
6	Gävle Hospital	Gävle		Sweden
7	Jönköping Hospital	Jönköping		Sweden
8	Kalmar Hospital	Kalmar		Sweden
9	Karlskrona Hospital	Karlskrona		Sweden
10	Kungälv Hospital	Kungälv		Sweden
11	Linköping University Hospital	Linköping		Sweden
12	Sunderby Hospital	Luleå		Sweden
13	Lycksele Hospital	Lycksele		Sweden
14	Skåne Universitetssjukhus	Malmö		Sweden
15	Mora Hospital	Mora		Sweden
16	Norrtälje Hospital	Norrtälje		Sweden
17	Nyköping Hospital	Nyköping		Sweden
18	Skellefteå Hospital	Skellefteå		Sweden
19	Skövde Hospital	Skövde		Sweden
20	Danderyd Hospital	Stockholm		Sweden
21	Stockholm South Hospital	Stockholm		Sweden
22	Trollhättan Hospital	Trollhättan		Sweden
23	Umeå University Hospital	Umeå		Sweden
24	Västervik Hospital	Västervik		Sweden
25	Västerås Hospital	Västerås		Sweden