NCT03472755

Brief Summary

Recent increased interest in tissue-sparing and minimally invasive arthroplasty has given rise to a sharp increase in the utilization of direct anterior total hip arthroplasty.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2018

Typical duration for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 21, 2018

Completed
2 days until next milestone

Study Start

First participant enrolled

March 23, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2020

Completed
Last Updated

June 11, 2026

Status Verified

June 1, 2026

Enrollment Period

1.7 years

First QC Date

February 5, 2018

Last Update Submit

June 10, 2026

Conditions

Keywords

hip arthroplastysurgeriesphysical fitnessperceptionenergetic costautonomy

Outcome Measures

Primary Outcomes (1)

  • hip's range of motion.

    1 year

Study Arms (2)

The posterolateral approach

OTHER

The posterolateral approach was used for implantation among patients in lateral position. This approach goes through the gluteus maximus, the piriformis and superior gemeli muscles are detached and later reattached to bone

Other: The posterolateral approach

Direct anterior techniques.

OTHER

. In the direct anterior technique, patients were fixed in a supine position, a small entry incision was made in the vessel free interval between the tensor fasciae latae and the sartorius muscles and the prosthesis socket were put in place. Via a second dorsal incision, after releasing the external rotators, the prosthesis stem and ball were implanted and the two parts of the prosthesis were attached.

Other: Direct anterior technique

Interventions

The posterolateral approach was used for implantation among patients in lateral position. This approach goes through the gluteus maximus, the piriformis and superior gemeli muscles are detached and later reattached to bone

The posterolateral approach

patients were fixed in a supine position, a small entry incision was made in the vessel free interval between the tensor fasciae latae and the sartorius muscles and the prosthesis socket were put in place. Via a second dorsal incision, after releasing the external rotators, the prosthesis stem and ball were implanted and the two parts of the prosthesis were attached

Direct anterior techniques.

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 50 years
  • Body mass index \< 35
  • Scheduled hip arthroplasty surgery

You may not qualify if:

  • No health coverage
  • Age \> 85 years
  • Body mass index ≥ 35
  • Cognitive impairment (score Mini Mental Statue \< 24)
  • Any other osteo-articular diseases than the operated hip, any muscular or neurological diseases that could penalize the walk

Contact the study team to confirm eligibility.

Sponsors & Collaborators

0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Patients provided written informed consent to participate in this study, as approved by the local ethics committee. Prior to surgery, patients were informed about the benefits and risk of the conventional posterolateral and direct anterior approaches. Then they performed postural test and a Performance-Oriented Mobility Assessment Walking test with and without step. After randomization, patients were operated according the conventional posterolateral or direct anterior techniques.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2018

First Posted

March 21, 2018

Study Start

March 23, 2018

Primary Completion

December 20, 2019

Study Completion

January 20, 2020

Last Updated

June 11, 2026

Record last verified: 2026-06