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Efficacy and Safety of Cemented and Cementless Prostheses for Unstable Intertrochanteric Fractures in the Elderly

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ClinicalTrials.gov Identifier: NCT03193697
Recruitment Status : Completed
First Posted : June 21, 2017
Last Update Posted : February 12, 2018
Sponsor:
Information provided by (Responsible Party):
Tiemiao Yu, Harrison International Peace Hospital

Brief Summary:
This trial explores the application of different hip replacement materials in elderly patients with unstable intertrochanteric fracture, and aims to provide the experience and basis for hip arthroplasty in elderly osteoporosis patients with unstable intertrochanteric fracture.

Condition or disease Intervention/treatment Phase
Intertrochanteric Fractures Device: cemented SPII prosthesis Device: cementless Wagner prosthesis Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Cemented and Cementless Prostheses in the Repair of Unstable Intertrochanteric Fractures in the Elderly: a Prospective, Single-center, Non-randomized, Controlled, Clinical Trial With 6-month Follow-up
Actual Study Start Date : January 1, 2014
Actual Primary Completion Date : June 1, 2016
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: control group
Old patients with unstable intertrochanteric fractures underwent total hip arthroplasty. Forty-four patients in the control group received a cemented SPII prosthesis (Link, Germany).
Device: cemented SPII prosthesis
Old patients with unstable intertrochanteric fractures underwent total hip arthroplasty. Forty-four patients in the control group received a cemented SPII prosthesis (Link, Germany).
Other Name: control group

Experimental: trial group
Old patients with unstable intertrochanteric fractures underwent total hip arthroplasty. Forty-two patients in the trial group received cementless Wagner prosthesis (Zimmer, USA).
Device: cementless Wagner prosthesis
Old patients with unstable intertrochanteric fractures underwent total hip arthroplasty. Forty-two patients in the trial group received cementless Wagner prosthesis (Zimmer, USA).
Other Name: trial group




Primary Outcome Measures :
  1. Harris hip scores [ Time Frame: at postoperative 6 months ]
    To assess the recovery of hip function.The number of patients with excellent and good Harris hip scores/total number of patients × 100%. High excellent and good rate indicates good hip function.


Secondary Outcome Measures :
  1. X-ray [ Time Frame: Changes from preoperative 6 months to postoperative 6 months ]
    To observe morphological changes in the hip.Morphology of the hip was observed in the anteroposterior and lateral images. Heterotopic ossification was classified via the Brooker classification system.



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Unstable intertrochanteric fractures identified by imaging and laboratory examination
  • Age: Greater than 65 years old
  • Irrespective of sex
  • Volunteered to participate in this test, and signed informed consent

Exclusion Criteria:

  • Replacement contraindications, such as acute myocardial infarction
  • Obvious obstacles in language communication and communication

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Responsible Party: Tiemiao Yu, Principal Investigator, Harrison International Peace Hospital
ClinicalTrials.gov Identifier: NCT03193697     History of Changes
Other Study ID Numbers: HarrisonIPH_01
First Posted: June 21, 2017    Key Record Dates
Last Update Posted: February 12, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries