NCT03210844

Brief Summary

Background The direct anterior approach (DAA) and micro-posterior approach (micro-PA) for total hip arthroplasty (THA) become popular approaches due to their fast recovery and good clinical outcomes. However, little is known if DAA is superior to micro-PA in implant positioning and functional outcomes for THA patients. Methods The investigators conducted a non-randomized comparative study to compare component positioning and clinical outcomes of the consecutive unilateral primary THA patients operated with DAA techniques and that of those operated with micro-PA techniques by a single surgeon. The investigators used DAA techniques with standard operation table and micro-PA techniques featuring indirect-contracture-releasing capsulotomy, preservation of short external rotators except piriformis and conjoint tendon, and tendon-to-bone capsulotendinous repair. The investigators used propensity-score matching analysis to compare the postoperative THA component positioning and clinical outcomes in DAA and micro-PA groups.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
141

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

October 1, 2013

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

June 25, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 7, 2017

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2017

Completed
Last Updated

July 7, 2017

Status Verified

June 1, 2017

Enrollment Period

3.8 years

First QC Date

June 25, 2017

Last Update Submit

July 6, 2017

Conditions

Keywords

total hip arthroplastydirect anteriorposterior approach

Outcome Measures

Primary Outcomes (3)

  • Radiographic component positions - femoral alignment

    femoral alignment - to measure the angle between the stem axis and proximal femur axis on X ray 3. Cup inclination angle

    Postoperative 2 year

  • Radiographic component positions - Cup anteversion angle

    to measure the cup anteversio angle on the X ray

    Postoperative 2 year

  • Radiographic component positions - Cup inclination angle

    to measure the cup inclination angle on the X ray

    Postoperative 2 year

Secondary Outcomes (10)

  • Leg length control

    Postoperative 2 year

  • Perioperative pain intensity

    postoperative 1st, 2nd and 3rd days

  • Morphine usage

    postoperative 1st, 2nd and 3rd days

  • Functional outcomes - Oxford hip score

    Postoperative 2 year

  • Functional outcomes - EQ5D score

    Postoperative 2 year

  • +5 more secondary outcomes

Study Arms (2)

Direct anterior approach

For the DAA group, we used single-incision direct anterior approach with a standard operation table in J Arthroplasty. 2008 Oct;23(7 Suppl):64-8. Epub 2008/10/24. . The incision size was 6-10 cm depending on the body build of the patient. The acetabularreaming was performed with an offset hemispheric reamer and acetabular component was inserted underfluoroscopic guidance. Femoral broaching was performed using a double-offset broach handle.Fluoroscopy was used to check the positioning and filling of femoral stem, as well as leg lengths.

Procedure: Surgical approaches of total hip arthroplasty

Microposterior approach

The incision size was 6 - 10 cm depending on the body build of the patient. The differences of our micro-PA from Dorr's techniques were: First, no excision of the anterosuperior capsule and medial inferior capsule because the senior author believe that preservation of these structures could help to maintain the postoperative stability of the THA. Second, after the gluteus minimus muscle was elevated from the superior capsule, a superior capsulomy starting from 12 o'clock direction of acetabulum in decubitus position was made. The hip capsule was then incised in 12-to- 6-o'clock downward direction and curved down around femoral neck under the other short external rotators. We preserved short external rotators except piriformis tendon. Third, the capsular incision was continued inferiorly following 12-to- 6-o'clock downward direction of acetabulum to the transverse acetabular ligament. The tube structure of original hip capsule was divided into anterior and posterior half leaflets.

Procedure: Surgical approaches of total hip arthroplasty

Interventions

Surgical approaches of total hip arthroplasty

Direct anterior approachMicroposterior approach

Eligibility Criteria

Age20 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with unilateral hip arthritis indicated for THA

patients with unilateral hip arthritis indicated for THA

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 106, Taiwan

Location

Study Officials

  • Wang Chen-Ti

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2017

First Posted

July 7, 2017

Study Start

October 1, 2013

Primary Completion

July 30, 2017

Study Completion

July 30, 2017

Last Updated

July 7, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations