External Validity of a Randomized Trial in Patients With a Femoral Neck Fracture

NCT02362971 | Active Not Recruiting

• 1 other identifier: External validity
• Study Type: observational
• Target: 900
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the external validity of a randomized controlled trial comparing choice of hip arthroplasty for elderly patients (\>80 years) with a displaced femoral neck fracture. The hypotheses are that patient reported hip function, quality of life are better and healthier in those included in the randomized controlled trial than those excluded. The external validity of the randomized controlled trial is acceptable. A prospective randomized controlled trial is planned and patients with a displaced femoral neck fracture will be included and randomized between either a hemiarthroplasty or total hip arthroplasty. All patients screened will be included in a prospective cohort study for evaluation of the external validity of the randomized controlled trial. The prospective cohort study will consist of 3 different groups. Patients included in the randomized controlled trial will form group 1. Patients eligible for the randomized controlled trial but did not give their informed consent and therefore excluded, form group 2. Patients with a femoral neck fracture which by any reason were excluded form group 3. Primary endpoint is patient-reported hip function (Harris hip score) and pain on the operated extremity evaluated with VAS (Visual Analogue Scale) and patient reported quality of life evaluated with EuroQol (EQ-5D). Secondary outcome measurement are the frequency of the complications, periprosthetic fracture, dislocation, revision surgery due to wound infection (deep and superficial) and loosening of the components. Baseline data, age, sex, comorbidity, cognitive status, weight, height, motor function, complications and reoperations. Follow up is performed 1-2 years after surgery. Group 1 is followed up in the ongoing randomized controlled trial by visits to the orthopedic department at Danderyd Hospital. Group 2 and 3 are followed up by telephone interview 1-2 year after surgery.

Conditions

Femoral Neck Fracture; Hip Fracture

Outcome Measures

Primary Outcomes (1)

• Harris hip score

  Hip function as a patient reported outcome measurement

  Up to 2 years

Secondary Outcomes (4)

• Baseline data (Preoperative baseline data obtained at admission to the hospital)

  1 day

• Mortality

  up to 2 years

• Complications (Any reason to reoperation)

  up to 4 years years

• EQ-5D

  up to 2 years

Study Arms (3)

Included

Patients included into the randomized controlled trial

Non-consenters

Patients eligible for participation in the randomized controlled trial but did not give their informed consent and thus excluded in the randomized controlled trial.

Excluded

Patients, by different reasons excluded from participation in the randomized controlled trial.

Eligibility Criteria

• Age: 80 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A femoral neck fracture in the elderly patient is a common cause of suffering and premature death in an aging population. Femoral neck fractures are mainly a fragility (osteoporotic) fracture, predominantly affecting women after menopause. Included in the study are elderly patients (\>80 years) with a displaced femoral neck fracture.

You may qualify if:

• Age above 80 years
• Acute (\<36h) displaced femoral neck fracture.
• Independent walker
• Abscence of cognitive impairment (Short Portable Mental Questionnaire \>7points)

You may not qualify if:

• Patient with osteoarthritis or rheumatoid arthritis in the fractured hip
• Pathological fracture
• Non walker
• Cognitive impairment (Short Portable Mental Questionnaire \<7points)
• Contraindication to total hip replacement due to wound, patients with comorbidities, deemed not suitable for a total hip replacement by the anesthesiologist, severe coagulation disorder, and severe drug abuse.
• Included into the randomized controlled trial.
• Did not give their informed consent for participation in the randomized controlled trial.
• Age below 80 years of age.

Sponsors & Collaborators

• Danderyd Hospital: lead

Study Sites (1)

Orthopaedic department, Danderyd Hospital

Stockholm, Stockholm County, 18288, Sweden

Location

Related Publications (6)

• Evidence-based health care: a new approach to teaching the practice of health care. Evidence-Based Medicine Working Group. J Dent Educ. 1994 Aug;58(8):648-53. No abstract available.

  PMID: 7930000 BACKGROUND

• Petersen MK, Andersen KV, Andersen NT, Soballe K. "To whom do the results of this trial apply?" External validity of a randomized controlled trial involving 130 patients scheduled for primary total hip replacement. Acta Orthop. 2007 Feb;78(1):12-8. doi: 10.1080/17453670610013367.

  PMID: 17453387 BACKGROUND

• Pibouleau L, Boutron I, Reeves BC, Nizard R, Ravaud P. Applicability and generalisability of published results of randomised controlled trials and non-randomised studies evaluating four orthopaedic procedures: methodological systematic review. BMJ. 2009 Nov 17;339:b4538. doi: 10.1136/bmj.b4538.

  PMID: 19920015 BACKGROUND

• van den Bekerom MP, Hilverdink EF, Sierevelt IN, Reuling EM, Schnater JM, Bonke H, Goslings JC, van Dijk CN, Raaymakers EL. A comparison of hemiarthroplasty with total hip replacement for displaced intracapsular fracture of the femoral neck: a randomised controlled multicentre trial in patients aged 70 years and over. J Bone Joint Surg Br. 2010 Oct;92(10):1422-8. doi: 10.1302/0301-620X.92B10.24899.

  PMID: 20884982 BACKGROUND

• Gao H, Liu Z, Xing D, Gong M. Which is the best alternative for displaced femoral neck fractures in the elderly?: A meta-analysis. Clin Orthop Relat Res. 2012 Jun;470(6):1782-91. doi: 10.1007/s11999-012-2250-6. Epub 2012 Jan 26.

  PMID: 22278852 BACKGROUND

• Rothwell PM. External validity of randomised controlled trials: "to whom do the results of this trial apply?". Lancet. 2005 Jan 1-7;365(9453):82-93. doi: 10.1016/S0140-6736(04)17670-8.

  PMID: 15639683 BACKGROUND

MeSH Terms

Conditions

Femoral Neck Fractures; Hip Fractures

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Olof G Skoldenberg, MD, PhD

  Department of clinical sciences at Danderyds hospital, Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: January 26, 2015
• First Posted: February 13, 2015
• Study Start: September 1, 2009
• Primary Completion: October 1, 2018
• Study Completion (Estimated): October 1, 2027
• Last Updated: August 30, 2016

Record last verified: 2016-08

Locations

SE (1)