Isokinetic Performance and Function After Total Hip Arthroplasty

Sponsor

Gulhane Training and Research Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04640740

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

2.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hip Osteoarthritis	Procedure: hip arthroplasty	N/A

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).

Study Design

Study Type:

Interventional

Actual Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jun 1, 2017

Actual Primary Completion Date :

Dec 30, 2018

Actual Study Completion Date :

Dec 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: anterolateral approach (ALA) anterolateral surgical approach of total hip arthroplasty	Procedure: hip arthroplasty two different approaches of total hip arthroplasty
Experimental: posterior approach (PA) posterior surgical approach of total hip arthroplasty.	Procedure: hip arthroplasty two different approaches of total hip arthroplasty

Arm

Intervention/Treatment

Experimental: anterolateral approach (ALA)

anterolateral surgical approach of total hip arthroplasty

Procedure: hip arthroplasty

two different approaches of total hip arthroplasty

Experimental: posterior approach (PA)

posterior surgical approach of total hip arthroplasty.

Procedure: hip arthroplasty

two different approaches of total hip arthroplasty

Outcome Measures

Primary Outcome Measures

isokinetic test [Change from preoperative isokinetic test results at 6th months and 12th months isokinetic test results]
isokinetic test during flexion, extension and abduction of the hip

Secondary Outcome Measures

Harris Hip Score [Change from preoperativeHarris Hip Score results at 6th months and 12th months iHarris Hip Score results]
Functional score of the hip. Harris Hip Score: 100-90: Excellent 89-80:Good 79-70:Fair below 70:Poor

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gulhane Teaching and Research Hospital	Ankara		Turkey	06010

Sponsors and Collaborators

Gulhane Training and Research Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Deniz CANKAYA, Assoc. Professor, Gulhane Training and Research Hospital

ClinicalTrials.gov Identifier:

NCT04640740

Other Study ID Numbers:

E-17-1415

First Posted:

Nov 23, 2020

Last Update Posted:

Nov 23, 2020

Last Verified:

Nov 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Deniz CANKAYA, Assoc. Professor, Gulhane Training and Research Hospital

anterolateral approach

posterior approach

isokinetic test

Additional relevant MeSH terms:

Osteoarthritis, Hip

Study Results

No Results Posted as of Nov 23, 2020