Back to resultsIsokinetic Performance and Function After Total Hip Arthroplasty
Primary Purpose
Hip Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
hip arthroplasty
Sponsored by
About this trial
This is an interventional treatment trial for Hip Osteoarthritis focused on measuring anterolateral approach, posterior approach, isokinetic test
Eligibility Criteria
Inclusion Criteria:
Patients aged 55 to 80 years unilateral primary hip osteoarthritis -
Exclusion Criteria:
bilateral osteoarthritis inflammatory arthritis post-traumatic osteoarthritis previous hip surgery neuromuscular diseases
Sites / Locations
- Gulhane Teaching and Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
anterolateral approach (ALA)
posterior approach (PA)
Arm Description
anterolateral surgical approach of total hip arthroplasty
posterior surgical approach of total hip arthroplasty.
Outcomes
Primary Outcome Measures
isokinetic test
isokinetic test during flexion, extension and abduction of the hip
Secondary Outcome Measures
Harris Hip Score
Functional score of the hip. Harris Hip Score: 100-90: Excellent 89-80:Good 79-70:Fair below 70:Poor
Full Information
NCT ID
NCT04640740
First Posted
November 18, 2020
Last Updated
November 18, 2020
Sponsor
Gulhane Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04640740
Brief Title
Isokinetic Performance and Function After Total Hip Arthroplasty
Official Title
Isokinetic Performance and Function Are Similar 12 Months After Total Hip Arthroplasty Applied With a Posterior or Anterolateral Approach: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
December 30, 2018 (Actual)
Study Completion Date
December 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gulhane Training and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
There are ongoing debates on the effects of the surgical approach on outcome after total hip arthroplasty. It was hypothesized that with the anterolateral approach, trauma to the abductor arm can be occured and related detrimental effects can diminish the post-operative outcomes. In this first randomized controlled trial in the literature on this subject, isokinetic performance and patient-reported functional outcomes were evaluated in patients undergoing total hip arthroplasty. with a posterior approach (PA) and a anterolateral approach (ALA), at 6 and 12 months postoperatively.
Detailed Description
Patients undergoing total hip arthroplasty are randomized to posterior approach (PA) and anterolateral approach (ALA) groups. The patients are evaluated preoperatively and at 6 and 12 months postoperatively, with flexion, extension and abduction strength measurements and the Harris Hip Score (HHS). The physiatrist performing isokinetic tests and the patients are blinded to the study groups.All data are calculated as mean and standard deviation values. The Student's t-test is used for statistical analysis of the patient data. Statistical calculations are performed using SPSS vn.22.0 software (IBM SPSS Statistics for Windows, Version 22.0. Armonk, NY, USA).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Osteoarthritis
Keywords
anterolateral approach, posterior approach, isokinetic test
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
anterolateral approach (ALA)
Arm Type
Experimental
Arm Description
anterolateral surgical approach of total hip arthroplasty
Arm Title
posterior approach (PA)
Arm Type
Experimental
Arm Description
posterior surgical approach of total hip arthroplasty.
Intervention Type
Procedure
Intervention Name(s)
hip arthroplasty
Intervention Description
two different approaches of total hip arthroplasty
Primary Outcome Measure Information:
Title
isokinetic test
Description
isokinetic test during flexion, extension and abduction of the hip
Time Frame
Change from preoperative isokinetic test results at 6th months and 12th months isokinetic test results
Secondary Outcome Measure Information:
Title
Harris Hip Score
Description
Functional score of the hip. Harris Hip Score: 100-90: Excellent 89-80:Good 79-70:Fair below 70:Poor
Time Frame
Change from preoperativeHarris Hip Score results at 6th months and 12th months iHarris Hip Score results
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients aged 55 to 80 years unilateral primary hip osteoarthritis -
Exclusion Criteria:
bilateral osteoarthritis inflammatory arthritis post-traumatic osteoarthritis previous hip surgery neuromuscular diseases
Facility Information:
Facility Name
Gulhane Teaching and Research Hospital
City
Ankara
ZIP/Postal Code
06010
Country
Turkey
12. IPD Sharing Statement
Citations:
PubMed Identifier
33896243
Citation
Cankaya D, Inci F, Karakus D, Turker HB, Kahve Y, Neyisci C. Isokinetic performance and function are similar after total hip arthroplasty applied with a posterior or anterolateral approach: a randomised controlled trial. Hip Int. 2023 Jan;33(1):67-72. doi: 10.1177/11207000211012989. Epub 2021 Apr 26.
Results Reference
derived
Learn more about this trial
Isokinetic Performance and Function After Total Hip Arthroplasty
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