Hip Fracture in Individuals Under 60 Years of Age

NCT03848195 | Completed

• 1 other identifier: HFU-60
• Study Type: observational
• Target: 218
• Locations: 2 countries
• Sites: 4

Brief Summary

This study prospectively analyses and describes a cohort of non-elderly hip fracture patients at four orthopaedic departments in two Scandinavian countries regarding epidemiology, treatment, Patient Reported Outcome Measures, functional outcome as well as clinical results.

Conditions

Hip Fractures

Keywords

hip fractures; adult; middle-aged; DXA-scan; osteoporosis

Outcome Measures

Primary Outcomes (15)

• Bone Mineral Density (BMD) at the time of the fracture

  Analysis of BMD measured by DXA-scan at the time of the fracture.

  Baseline

• Trauma mechanism leading to the hip fracture

  Analysis of trauma mechanism, defined as "low-energy trauma" or "not low-energy trauma", leading to the hip fracture.

  Baseline

• Hip fracture type according to Garden classification (femoral neck fractures) and Arbeitsgemeinschaft für Osteosynthesefragen (AO)-classification (other hip fractures)

  Analysis of the patients' hip fracture types on diagnostic radiographs.

  Baseline

• EQ-5D

  Analysis of outcome with EQ5D (PROM). A 5 dimensions, 3-levels, questionnaire regarding general health. A subscore of 1-3 for each dimension combines into a 5 digit code where lower value for each dimension indicate better outcome (total range 11111-33333).

  Patients are followed up during two years

• EQ-VAS

  Analysis of outcome with EQ-VAS (PROM). A visual analog scale regarding general health ranging from 0-100 where lower value indicate worse outcome.

  Patients are followed up during two years

• Oxford Hip Score

  Analysis of outcome with Oxford Hip Score (PROM). A 12-item, 5-levels, questionnaire on hip problems in activities of daily living. The subscores 0-4 is added to a total score for the 12 items where a higher score indicate a better outcome (total range 0-48).

  Patients are followed up during two years

• VAS-pain, satisfaction, rehabilitation (VAS-psr)

  Analysis of outcome with VAS-psr (PROM). Three visual analog scales (one for each dimension) regarding pain, satisfaction and rehabilitation ranging from 0-100 where lower value indicate better outcome.

  Patients are followed up during two years

• New Mobility Score

  Analysis of outcome with New Mobility Score (PROM). A 3-items questionnaire regarding walking ability. Each item is scored 1-3 and added into a total score where higher score indicate better outcome (total range 3-9).

  Patients are followed up during two years

• Timed up and go

  Analysis of outcome with timed up and go test (functional) measured in seconds. Shorter time indicates better outcome.

  Patients are followed up during two years

• 10 meter walking test

  Analysis of outcome with 10 meter walking test (functional) measured in seconds. Shorter time indicates better outcome.

  Patients are followed up during two years

• Hand grip strength

  Analysis of outcome with hand grip strength (functional) measured in kg. Higher value indicates better outcome.

  Patients are followed up during two years

• Complications after hip fracture surgery

  Type and rate of complications after hip fracture surgery (clinical) are recorded.

  Patients are followed up during two years

• Reoperations after hip fracture surgery

  Type and frequency of reoperations after hip fracture surgery (clinical).

  Patients are followed up during two years

• Radiological outcome after hip fracture surgery

  Analysis of radiological outcome after hip fracture surgery. Radiographs are assessed according to pre-defined criteria.

  Patients are followed up during two years

• Diagnosis of avascular necrosis by MRI with metal artefact reduction

  Analysis of the use of MRI MARS to assess avascular necrosis of the femoral head in patients with femoral neck fracture treated with internal fixation.

  Patients are followed up during two years

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Among hip fracture patients treated at the participating departments, patients aged 18 to 59 years, who sustain an acute non-pathological hip fracture and are treated within four weeks, are invited to participate in the study. All patients are invited, regardless of medical, cognitive and functional pre-fracture status. The participating orthopaedic departments are part of local hospitals, treating all patients in the catchment area who seeks medical care at low (Sweden) or no cost (Denmark).

You may qualify if:

• Acute non-pathologic hip fracture regardless of trauma energy level or previous medical conditions.

You may not qualify if:

• Fracture older than four weeks.
• Not able to follow up, e.g. not living in the department area.

Sponsors & Collaborators

• Lund University: lead
• University of Copenhagen: collaborator
• University of Southern Denmark: collaborator

Study Sites (4)

Department of Orthopaedics, Copenhagen University Hospital Hvidovre

Hvidovre, 2650, Denmark

Location

Department of Orthopaedic Surgery and Traumatology, Kolding Hospital - part of Hospital Lillebaelt

Kolding, 6000, Denmark

Location

Department of Orthopaedic Surgery and Traumatology, Odense University Hospital

Odense, 5000, Denmark

Location

Skane University Hospital, Department of Orthopaedics

Malmo, 20502, Sweden

Location

MeSH Terms

Conditions

Hip Fractures; Osteoporosis

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Cecilia Rogmark, MD, PhD

  Lund University, Skane University Hospital, Department of Orthopaedics, Sweden

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, orthopaedic surgeon, PhD-student

Study Record Dates

• First Submitted: November 28, 2018
• First Posted: February 20, 2019
• Study Start: July 29, 2015
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: December 12, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (3); SE (1)