Skip to main content
OpenTrials
Completed

NCT Number: NCT03695497

Direct Anterior Approach for Femoral Neck Fractures

The primary objective is to examine if in patients with a dislocated femoral neck fracture who receive a total hip arthroplasty, direct anterior approach will give a better result in terms of mobilization, function and pain in the first weeks and months postoperatively, than direct lateral approach.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kristiansund Hospital

Kristiansund, Norway

About this study

first included patient 23th November 2018

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Dislocated femoral neck fracture

Exclusion criteria

  • Infection around the hip (soft tissue or bone)
  • Pathologic fracture
  • Excessive alcohol or substance abuse that most likely will give reduced compliance
  • Patients with any fractures of the long bones in the lower extremity, fracture of the spine, and/or intra-thoracic or intra-abdominal injury (i.e., multiple trauma). Because the outcomes and clinical course of patients with multiple trauma may be quite different from a non-trauma patient.
  • Bedridden patients/non-walkers
  • Patients with an underlying illness that doesn't have life expectancy beyond six months
  • In case of severe cognitive impairment where the patients are not able to give their informed consent

Treatment and study plan

direct anterior approach

Procedure

total hip arthroplasty with DAA

Other names: DAA

direct lateral approach

Procedure

total hip arthroplasty with DLA

Other names: DLA

Primary outcomes

  1. Difference in Timed Up and Go Test (TUG) between the groups

    Time frame: 6 weeks postoperatively.

    It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.

Secondary outcomes

  1. Difference in Forgotten Joint Score for hip (FJS-12) between the groups

    Time frame: 2,6,12 weeks, and 1 year

    12 questions. Every question is scored 1 (never) to 5 (mostly) according to the selected response categories. Thus, the raw score ranges from 12 to 60. The raw score is linearly transformed to a 0-100 scale and then reversed to obtain the final score. Final score = 100 - ((sum(item01 to item12) - 12)/48*100) For the final 'Forgotten Joint Score -12' a high score indicates good outcome.

  2. Difference in EQ-5D-5L score between the groups

    Time frame: 2,6,12 weeks, and 1 year

    5 questions. Every question is scored 1 to 5 where 5 is worse outcome. For example one profile could be' 12233'. As there is no Norwegian index, the EQ5D-5L was converted into a Swedish index score.

  3. Difference in Oxford Hip Score (OHS) between the groups

    Time frame: 2,6,12 weeks, and 1 year

    12 questions. Every question is scored 4 to 0 according to the selected response. Thus the highest score on 48 means a perfectly functioning hip, while a score on 0 means the worst outcome.

  4. Difference in Timed Up and Go Test (TUG) between the groups

    Time frame: 2,12 weeks, 1 year.

    It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down

  5. Difference in EQ5D-VAS between the groups

    Time frame: 2,6,12 weeks, and 1 year

    Respondents report their perceived health status with a grade ranging from 0 (worst possible health status) to 100 (best possible health status).

  6. radiological results 1.

    Time frame: postoperative, 3,12 months.

    We will look at the offset of the hip prosthesis.

  7. radiological results 2.

    Time frame: postoperative, 3,12 months.

    We will look at alignment of the stem. Femoral component angulation between 3° varus and 3° valgus relative to the femoral shaft axis will be considered neutral. Positioning outside this references will be graded as varus or valgus

  8. radiological results 3.

    Time frame: postoperative, 3,12 months.

    We will look at quality of stem cementation by Barrack

  9. radiological results 4.

    Time frame: postoperative, 3,12 months.

    We will look at leg length. It will be measured using the vertical height from the interteardrop line.

  10. radiological results 5.

    Time frame: postoperative, 3,12 months.

    We will look at inclination of the cup.It will be measured in reference to the interteardrop line.

  11. radiological results 6.

    Time frame: postoperative, 3,12 months.

    We will look at anteversion of the cup. It will be measured using the ischiolateral method.

  12. complications

    Time frame: Within the first year postoperatively.

    periprosthetic fractures, dislocation, implant failure, neurovascular injury, infection. abductor failure, neurapraxia of LFCN), and mortality

Other outcomes

  1. Change in CK (Creatine Kinase)

    Time frame: preoperatively and day 1,2,3,4 postoperatively.

    Measure CK preoperatively and the first 4 postoperative days.

  2. Change in CRP (C-Reactive Protein)

    Time frame: preoperatively and day 1,2,3,4 postoperatively.

    Measure CRP preoperatively and the first 4 postoperative days.

  3. Change in Hb (Hemoglobin)-levels.

    Time frame: preoperatively and day 1,2,3,4 postoperatively.

    Measure Hb preoperatively and the first 4 postoperative days.

Sponsors and collaborators

Lead sponsor

Helse Møre og Romsdal HF

Other Gov

Collaborators

  • Kristiansund Hospital
  • St. Olavs Hospital

Registry information

Official study title

A Randomized Controlled Trial Comparing Direct Anterior Approach to Direct Lateral Approach in Patients Receiving a Total Hip Arthroplasty for Femoral Neck Fracture - a 1 Year Follow-up Study

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Oct 4, 2018
Registry last updated
Nov 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.