NCT04640740

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

June 1, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2018

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 18, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 23, 2020

Completed
Last Updated

November 23, 2020

Status Verified

November 1, 2020

Enrollment Period

1.6 years

First QC Date

November 18, 2020

Last Update Submit

November 18, 2020

Conditions

Keywords

anterolateral approachposterior approachisokinetic test

Outcome Measures

Primary Outcomes (1)

  • isokinetic test

    isokinetic test during flexion, extension and abduction of the hip

    Change from preoperative isokinetic test results at 6th months and 12th months isokinetic test results

Secondary Outcomes (1)

  • Harris Hip Score

    Change from preoperativeHarris Hip Score results at 6th months and 12th months iHarris Hip Score results

Study Arms (2)

anterolateral approach (ALA)

EXPERIMENTAL

anterolateral surgical approach of total hip arthroplasty

Procedure: hip arthroplasty

posterior approach (PA)

EXPERIMENTAL

posterior surgical approach of total hip arthroplasty.

Procedure: hip arthroplasty

Interventions

two different approaches of total hip arthroplasty

anterolateral approach (ALA)posterior approach (PA)

Eligibility Criteria

Age55 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 55 to 80 years unilateral primary hip osteoarthritis -

You may not qualify if:

  • bilateral osteoarthritis inflammatory arthritis post-traumatic osteoarthritis previous hip surgery neuromuscular diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gulhane Teaching and Research Hospital

Ankara, 06010, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Osteoarthritis, Hip

Interventions

Arthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Professor

Study Record Dates

First Submitted

November 18, 2020

First Posted

November 23, 2020

Study Start

June 1, 2017

Primary Completion

December 30, 2018

Study Completion

December 30, 2018

Last Updated

November 23, 2020

Record last verified: 2020-11

Locations