NCT04687592

Brief Summary

Does the current techniques of internal fixation of vertical neck fracture in young adult patients give a satisfactory radiological and functional outcome at one year follow up?

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2021

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 29, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

December 29, 2020

Status Verified

December 1, 2020

Enrollment Period

2 years

First QC Date

November 15, 2020

Last Update Submit

December 25, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • radiological and functional evaluation of the time and rate of union according harris hip score

    The domains covered in Harris hip score are pain, function, absence of deformity, and range of motion. The pain domain measures pain severity and its effect on activities and need for pain medication. The function domain consists of daily activities (stair use, using public transportation, sitting, and managing shoes and socks) and gait (limp, support needed, and walking distance). Deformity takes into account hip flexion, adduction, internal rotation, and extremity length discrepancy. Range of motion measures hip flexion, abduction, external and internal rotation, and adduction .

    one year

Interventions

* Reduction: one trial of closed reduction under anaesthesia and image control. Open reduction will be done by anterolateral or lateral approach if closed reduction failed * Fixation: internal fixation of the fracture by appropriate implant according to the fracture state

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

adults patients with recent vertical femoral neck fracture

You may qualify if:

  • Age of the patients from 20 to 50 years
  • Pauwel type III fractures
  • Recent fracture within one week

You may not qualify if:

  • Open fractures
  • Pathological or osteoporotic fractures.
  • Patient with comorbidities: D.M, renal patient, neurological deficits.
  • Patient associated with femoral head fractures or head impaction.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Macaulay W, Yoon RS, Parsley B, Nellans KW, Teeny SM; DFACTO Consortium. Displaced femoral neck fractures: is there a standard of care? Orthopedics. 2007 Sep;30(9):748-9. doi: 10.3928/01477447-20070901-08.

    PMID: 17899921BACKGROUND
  • Bartonicek J. Pauwels' classification of femoral neck fractures: correct interpretation of the original. J Orthop Trauma. 2001 Jun-Jul;15(5):358-60. doi: 10.1097/00005131-200106000-00009.

    PMID: 11433141BACKGROUND
  • Ye Y, Hao J, Mauffrey C, Hammerberg EM, Stahel PF, Hak DJ. Optimizing Stability in Femoral Neck Fracture Fixation. Orthopedics. 2015 Oct;38(10):625-30. doi: 10.3928/01477447-20151002-05.

    PMID: 26488776BACKGROUND
  • Collinge CA, Mir H, Reddix R. Fracture morphology of high shear angle "vertical" femoral neck fractures in young adult patients. J Orthop Trauma. 2014 May;28(5):270-5. doi: 10.1097/BOT.0000000000000014.

    PMID: 24096307BACKGROUND
  • Luttrell K, Beltran M, Collinge CA. Preoperative decision making in the treatment of high-angle "vertical" femoral neck fractures in young adult patients. An expert opinion survey of the Orthopaedic Trauma Association's (OTA) membership. J Orthop Trauma. 2014 Sep;28(9):e221-5. doi: 10.1097/BOT.0000000000000080.

    PMID: 25148589BACKGROUND

MeSH Terms

Conditions

Femoral Neck Fractures

Condition Hierarchy (Ancestors)

Hip FracturesFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Central Study Contacts

thomas magdi labieb

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident at orthopedic department

Study Record Dates

First Submitted

November 15, 2020

First Posted

December 29, 2020

Study Start

June 1, 2021

Primary Completion

June 1, 2023

Study Completion

September 1, 2023

Last Updated

December 29, 2020

Record last verified: 2020-12