NCT02645435

Brief Summary

Background: Direct anterior approach to the hip (DAA) is being considered as one of the most promising minimally-invasive approaches in total hip arthroplasty (THA). Purpose of this study is to analyse influence of learning curve on clinical and radiographic outcome in direct anterior approach (DAA) for total hip replacement. Methods: The first 30 patients operated with DAA (group B) were compared to 39 patients operated by Hardinge approach (group A). Peri-and postoperative complications, Harris Hip Score (HHS), implant positioning, experienced pain and patient satisfaction were evaluated at a mean follow-up of 32 months.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
69

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Dec 2015

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

December 1, 2015

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

December 29, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 1, 2016

Completed
Last Updated

January 1, 2016

Status Verified

December 1, 2015

Enrollment Period

Same day

First QC Date

December 29, 2015

Last Update Submit

December 31, 2015

Conditions

Arthropathy of HipSurgery

Outcome Measures

Primary Outcomes (1)

  • Clinical outcome of direct hip approach

    Harry's hip score, a clinical score used in orthopedic surgery to describe outcome of hip function

    32 months

Secondary Outcomes (2)

  • radiological positioning of cup in the replaced hip

    32 months

  • radiological positioning of the stem in replaced hip

    32 months

Study Arms (2)

Hip direct anterior approach

ACTIVE COMPARATOR

Patients with hip arthritis

Procedure: hip replacement

Lateral hip approach

ACTIVE COMPARATOR

Patients with hip arthritis

Procedure: hip replacement

Interventions

hip replacementPROCEDURE

Total hip replacement

Hip direct anterior approachLateral hip approach

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Hip arthritis

You may not qualify if:

  • BMI\>35

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Arthroplasty, Replacement, Hip

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

December 29, 2015

First Posted

January 1, 2016

Study Start

December 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

January 1, 2016

Record last verified: 2015-12