Full Versus Partial Repairing of Soft Tissue Surrounding the Hip in Arthroplasty for Femoral Neck Fractures

September 7, 2016 updated by: Haibo Lu, First Hospitals affiliated to the China PLA General Hospital

Full Repairing Versus Partial Repairing of Soft Tissue Surrounding the Hip Joint in Hip Arthroplasty for Femoral Neck Fractures

A prospective cohort study to compare full repairing and partial repairing of soft tissue surrounding the hip joint in anteriorolateral approaching arthroplasty concerning hip function. Patients admitted with a femoral neck fracture operated with a hip arthroplasty through an anteriorolateral approach were screened for inclusion. Patients with altered mental status SPMSQ <7, pathological fractures, non-walkers were excluded.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Those who fulfilled the inclusion criteria and non of the exclusion criteria were followed 2 months postoperatively by clinical examination. Sample size were estimated to 15 patients in each group. Primary outcome variables were trendelenburg test, abductor strength measured with dynamometry. Secondary outcome variables were WOMAC, EQ-5D, and VAS scores.

Study Type

Observational

Enrollment (Anticipated)

30

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with femoral neck fractures undergoing hip arthroplasty through anteriorolateral approach.

Description

Inclusion Criteria:

  • Displaced femoral neck fracture
  • Walker
  • Hemiarthroplasty or Total Hip Arthroplasty
  • Preiffer test >7/10

Exclusion Criteria:

  • Pathological fracture
  • Non-walker
  • Pfeiffer test <7/10 indicating mental alteration

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Full Repairing of soft tissue surrounding the hip
Full repairing soft tissue surrounding the hip damaged during the procedure of hip dislocation and prosthesis implanting
Procedure: Full Repairng of soft tissue surrounding the hip
Full repairing soft tissue surrounding the hip damaged during the procedure of hip dislocation and prosthesis implanting.
Partial Repairing of soft tissue surrounding the hip
Partial repairing soft tissue surrounding the hip damaged during the procedure of hip dislocation and prosthesis implanting
Procedure: Partial Repairng of soft tissue surrounding the hip
Partial repairing soft tissue surrounding the hip damaged during the procedure of hip dislocation and prosthesis implanting.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trendelenburg Test
Time Frame: At 4 week postoperatively
30 seconds standing on the operated leg
At 4 week postoperatively
Abductor strength
Time Frame: At 4 week postoperatively
Dynamometry
At 4 week postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
WOMAC
Time Frame: At 2, 4, 6 weeks and 12 months postoperatively
An established hip score
At 2, 4, 6 weeks and 12 months postoperatively
Quality of life (EQ-5D)
Time Frame: At 2, 4, 6 weeks and 12 months postoperatively
EQ-5D
At 2, 4, 6 weeks and 12 months postoperatively
Pain (Visual analouge scale)
Time Frame: At 2, 4, 6 weeks and 12 months postoperatively
Visual analouge scale (VAS): At rest and during activity
At 2, 4, 6 weeks and 12 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Hospitals affiliated to the China PLA General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Anticipated)

November 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

August 24, 2016

First Submitted That Met QC Criteria

September 7, 2016

First Posted (Estimate)

September 13, 2016

Study Record Updates

Last Update Posted (Estimate)

September 13, 2016

Last Update Submitted That Met QC Criteria

September 7, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1 (Other Identifier: Mobile Health and Wellness Program)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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