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| Name | Class |
|---|---|
| The Swedish Research Council | OTHER_GOV |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arthroplasty | Experimental | Arthroplasty, hemi or total depending on patient characteristics and surgeon's choice |
|
| Internal Fixation | Active Comparator | Internal fixation with 2-3 screws or pins, or sliding hip screw device, depending on each hospital's routine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arthroplasty | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Composite variable comprising reoperation rate and mortality | Both Death and mortality will be accounted for | 1 to 2-year post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Reoperation rate | Minor and major reoperations will be noted | 2-year post-surgery |
| Long-term Mortality | All deaths are recorded | 2-year post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of adverse events. | Adverse events, such as pulmonary embolism, infection, dislocation, myocardial infarction and stroke will be noted. | 1-year post-surgery |
| Long-term reoperation rate | Minor and major reoperations will be noted |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wolf Olof, MD, PhD | Contact | +46186111707 | olof.wolf@surgsci.uu.se |
| Name | Affiliation | Role |
|---|---|---|
| Stergios Lazarinis | Uppsala University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uppsala University Hospital | Recruiting | Uppsala | Uppsala County | 75185 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28665454 | Background | Onativia IJ, Slullitel PA, Diaz Dilernia F, Gonzales Viezcas JM, Vietto V, Ramkumar PN, Buttaro MA, Piuzzi NS. Outcomes of nondisplaced intracapsular femoral neck fractures with internal screw fixation in elderly patients: a systematic review. Hip Int. 2018 Jan;28(1):18-28. doi: 10.5301/hipint.5000532. | |
| 30653043 | Background |
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| Internal Fixation | Device | 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. |
|
| Short-term Mortality | All deaths are recorded | 30 day mortality |
| Patient reported outcome: SMFA | 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. | 1-year post surgery |
| 5 and 10 years post-surgery |
| External validity | Assessment of eligible patients not included in the study | 2-year post-surgery |
| Alingsås Hospital | Recruiting | Alingsås | Sweden |
|
| Borås Hospital | Recruiting | Borås | Sweden |
|
| Falu Hospital | Recruiting | Falun | Sweden |
|
| Gävle Hospital | Recruiting | Gävle | Sweden |
|
| Sahlgrenska university Hospital | Recruiting | Gothenburg | Sweden |
|
| Jönköping Hospital | Recruiting | Jönköping | Sweden |
|
| Kalmar Hospital | Recruiting | Kalmar | Sweden |
|
| Karlskrona Hospital | Recruiting | Karlskrona | Sweden |
|
| Kungälv Hospital | Recruiting | Kungälv | Sweden |
|
| Linköping University Hospital | Recruiting | Linköping | Sweden |
|
| Sunderby Hospital | Recruiting | Luleå | Sweden |
|
| Lycksele Hospital | Recruiting | Lycksele | Sweden |
|
| Skåne Universitetssjukhus | Recruiting | Malmö | Sweden |
|
| Mora Hospital | Recruiting | Mora | Sweden |
|
| Norrtälje Hospital | Not yet recruiting | Norrtälje | Sweden |
|
| Nyköping Hospital | Recruiting | Nyköping | Sweden |
|
| Skellefteå Hospital | Recruiting | Skellefteå | Sweden |
|
| Skövde Hospital | Recruiting | Skövde | Sweden |
|
| Danderyd Hospital | Recruiting | Stockholm | Sweden |
|
| Stockholm South Hospital | Not yet recruiting | Stockholm | Sweden |
|
| Trollhättan Hospital | Recruiting | Trollhättan | Sweden |
|
| Umeå University Hospital | Recruiting | Umeå | Sweden |
|
| Västerås Hospital | Recruiting | Västerås | Sweden |
|
| Västervik Hospital | Recruiting | Västervik | Sweden |
|
| Dolatowski FC, Frihagen F, Bartels S, Opland V, Saltyte Benth J, Talsnes O, Hoelsbrekken SE, Utvag SE. Screw Fixation Versus Hemiarthroplasty for Nondisplaced Femoral Neck Fractures in Elderly Patients: A Multicenter Randomized Controlled Trial. J Bone Joint Surg Am. 2019 Jan 16;101(2):136-144. doi: 10.2106/JBJS.18.00316. |
| 31964340 | Derived | Wolf O, Sjoholm P, Hailer NP, Moller M, Mukka S. Study protocol: HipSTHeR - a register-based randomised controlled trial - hip screws or (total) hip replacement for undisplaced femoral neck fractures in older patients. BMC Geriatr. 2020 Jan 21;20(1):19. doi: 10.1186/s12877-020-1418-2. |
| ID | Term |
|---|---|
| D005265 | Femoral Neck Fractures |
| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
| D007869 | Leg Injuries |
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| ID | Term |
|---|---|
| D001178 | Arthroplasty |
| D005593 | Fracture Fixation, Internal |
| ID | Term |
|---|---|
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
| D019651 | Plastic Surgery Procedures |
| D005592 | Fracture Fixation |
| D013812 | Therapeutics |
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