Brief Summary

Determining the best approach for a total hip arthroplasty (THA) implies that the procedure is kind on soft tissues, with the lowest complication rates, and easily reproducible. Although there have been several attempts to resolve this issue in the last decade, a definitive answer has not been found. Therefore, the investigators performed a prospective study to compare direct anterior versus posterior approach based on (1) hospital stay, (2) functional outcome, (3) pain, (4) implant position (5) complications and (6) surgical time.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2011

Typical duration for not_applicable

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

February 1, 2011

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 17, 2018

Completed
Last Updated

September 20, 2018

Status Verified

September 1, 2018

Enrollment Period

2.4 years

First QC Date

September 12, 2018

Last Update Submit

September 18, 2018

Conditions

Keywords

Direct anterior approachposterior approach

Outcome Measures

Primary Outcomes (1)

  • Hospital stay

    Length in days of hospital stay

    Between 0 days and 1 month, average of 4 days

Secondary Outcomes (5)

  • functional recovery

    2 weeks, 4 weeks, 3 months, 6 months, 1 year, 2 years and 5 years postoperatively

  • pain assessment: VAS

    2 weeks, 4 weeks, 3 months, 6 months, 1 year, 2 years and 5 years postoperatively

  • implant position

    2 weeks, 4 weeks, 3 months, 6 months, 1 year, 2 years and 5 years postoperatively

  • number of patients with per/post surgical complications.

    2 weeks, 4 weeks, 3 months, 6 months, 1 year, 2 years and 5 years postoperatively

  • surgical time

    Up to 240 minutes

Study Arms (2)

THA Posterior Approach

ACTIVE COMPARATOR

The posterior approach to the hip has been described by many authors and yields good results. Implants used were Quadra®-H stem and Versacup® hip system, Medacta, Switzerland, with metal on polyethylene bearing. All implants were non-cemented.

Procedure: Total hip arthroplasty

THA Direct anterior approach

ACTIVE COMPARATOR

The modified Hueter approach, based on the Smith-Peterson approach, was performed for the direct anterior minimally invasive surgery. This approach could have some advantages as it is a muscle sparing approach, hence yielding a faster recovery. A traction table was used for DAA as surgeons were trained to use this method. No intra-operative fluoroscopy was used for implant confirmation.Implants used were Quadra®-H stem and Versacup® hip system, Medacta, Switzerland, with metal on polyethylene bearing. All implants were non-cemented.

Procedure: Total hip arthroplasty

Interventions

Two fellowship-trained surgeons in two separate hospitals performed all procedures. Both surgeons had previously performed over 100 cases with each approach, before initiating this study

THA Direct anterior approachTHA Posterior Approach

Eligibility Criteria

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

You may qualify if:

  • primary total hip replacement due to osteoarthrosis or osteonecrosis
  • patients older than 50 years.

You may not qualify if:

  • inflammatory arthritis,
  • any previous ipsilateral hip surgery
  • suffering from proximal femoral deformity
  • BMI over 40
  • active infection
  • severe contralateral hip disease, muscle contractures or neuromuscular pathology
  • requiring structural bone grafts.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Moerenhout K, Derome P, Laflamme GY, Leduc S, Gaspard HS, Benoit B. Direct anterior versus posterior approach for total hip arthroplasty: a multicentre, prospective, randomized clinical trial. Can J Surg. 2020 Sep-Oct;63(5):E412-E417. doi: 10.1503/cjs.012019.

MeSH Terms

Interventions

Arthroplasty, Replacement, Hip

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
However, the decision to discharge subjects was made by physiotherapists blinded to treatment and based on objective criteria. These criteria were: 1) being autonomous for transfer from bed/chair to upright position 2) being able to walk with walking aid 3) climbing stairs in a safe way 4) having a pain level contained by painkillers. No restrictions were recommended for either group. The same rehabilitation and pain protocols were used for both approaches. In addition, statistical analyses were performed by an independent consultant who remained blinded to treatment group assignment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Orthopedic Surgeon

Study Record Dates

First Submitted

September 12, 2018

First Posted

September 17, 2018

Study Start

February 1, 2011

Primary Completion

July 1, 2013

Study Completion

August 1, 2013

Last Updated

September 20, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

There is no plan to share IPD