NCT06538519

Brief Summary

The goal of this Prospective Randomized Study is to confirm presence or absence of differences in gait mechanics in direct anterior and lateral approaches for total hip arthroplasty. and to compare the clinical outcomes of both approaches. The main questions it aims to answer are: if the anterior approach to the hip is faster recovery than lateral approach? if the anterior approach to the hip has better gait mechanics than lateral approach? Participants will: undergo one of the two approaches for total hip arthroplasty. All patients will be followed up at 2 weeks, 6 weeks, 3 months and 18 months. gait analysis will be done at 6wks, 3m, and 18months.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable

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

January 3, 2021

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2023

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

July 7, 2024

Completed
29 days until next milestone

First Posted

Study publicly available on registry

August 5, 2024

Completed
Last Updated

August 5, 2024

Status Verified

July 1, 2024

Enrollment Period

2.4 years

First QC Date

July 7, 2024

Last Update Submit

August 2, 2024

Conditions

Hip Osteoarthritis

Keywords

arthroplasty

Outcome Measures

Primary Outcomes (5)

  • surgery time

    by ''Minute'' as the unit, no special description.

    intraoperative time starting from skin incision to skin closure

  • hemoglobin drop

    hemoglobin drop level between pre and postoperative.

    postoperative day one

  • hospital stays

    by ''Day'' as the unit, no special description. postoperative stay days from operation day to discharge day.

    immediately after the procedure

  • pain score

    using visual analogue scale (VAS) from 0-10 the more scale the worst the pain

    2 weeks 6 weeks 3 months 18 months

  • Harris hip score

    for measuring hip function from 0-100 the more the score the better hip function

    2 weeks 6 weeks 3 months 18 months

Secondary Outcomes (1)

  • gait analysis

    at 6 weeks, 3 months, 18 months

Study Arms (2)

direct anterior approach group

ACTIVE COMPARATOR
Procedure: total hip replacement using anterior approachDevice: gait analysis at 6wks, 3 months and 18 months

lateral approach group

ACTIVE COMPARATOR
Procedure: total hip replacement using lateral approachDevice: gait analysis at 6wks, 3 months and 18 months

Interventions

total hip replacement using lateral approachPROCEDURE

In the lateral approach partial detachment of the anterior one-third of the gluteus medius muscle.

lateral approach group
total hip replacement using anterior approachPROCEDURE

the anterior approach using an internervous plane between the tensor fascia latae and the sartorius muscle.

direct anterior approach group
gait analysis at 6wks, 3 months and 18 monthsDEVICE

gait analysis done in the gait lab at the mentioned postoperative periods

direct anterior approach grouplateral approach group

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with primary osteoarthritis or osteonecrosis of the hip who consented for treatment with a total hip arthroplasty (THA) through an anterior or lateral approach.
  • Age between 20 - 60 years of age.
  • The participant had to be independent and physically active, which characterized as having the capacity to carry out daily tasks, ascend two flights of stairs, and able to walk for 15 minutes.

You may not qualify if:

  • Patients with bilateral hip affection.
  • Body mass index (BMI) greater than 40.
  • Diagnosis other than primary osteoarthritis or osteonecrosis.
  • Prior hip or spine surgery.
  • chronic uncontrolled comorbidities, psychological disorders.
  • American Society of Anaesthesiologists score (ASA) higher than 2
  • chronic neurological deficits that influence gait.
  • any limb length discrepancy more than 1 cm.
  • Any postoperative complication that will lead to delay in weight bearing.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University Hospitals

Cairo, Abbasia, Egypt

Location

Related Publications (8)

  • Wang Z, Bao HW, Hou JZ. Direct anterior versus lateral approaches for clinical outcomes after total hip arthroplasty: a meta-analysis. J Orthop Surg Res. 2019 Feb 26;14(1):63. doi: 10.1186/s13018-019-1095-z.

    PMID: 30808382BACKGROUND

  • Pospischill M, Kranzl A, Attwenger B, Knahr K. Minimally invasive compared with traditional transgluteal approach for total hip arthroplasty: a comparative gait analysis. J Bone Joint Surg Am. 2010 Feb;92(2):328-37. doi: 10.2106/JBJS.H.01086.

    PMID: 20124059BACKGROUND

  • Yue C, Kang P, Pei F. Comparison of Direct Anterior and Lateral Approaches in Total Hip Arthroplasty: A Systematic Review and Meta-Analysis (PRISMA). Medicine (Baltimore). 2015 Dec;94(50):e2126. doi: 10.1097/MD.0000000000002126.

    PMID: 26683920BACKGROUND

  • Graves SC, Dropkin BM, Keeney BJ, Lurie JD, Tomek IM. Does Surgical Approach Affect Patient-reported Function After Primary THA? Clin Orthop Relat Res. 2016 Apr;474(4):971-81. doi: 10.1007/s11999-015-4639-5. Epub 2015 Nov 30.

    PMID: 26620966BACKGROUND

  • Alecci V, Valente M, Crucil M, Minerva M, Pellegrino CM, Sabbadini DD. Comparison of primary total hip replacements performed with a direct anterior approach versus the standard lateral approach: perioperative findings. J Orthop Traumatol. 2011 Sep;12(3):123-9. doi: 10.1007/s10195-011-0144-0. Epub 2011 Jul 12.

    PMID: 21748384BACKGROUND

  • Reichert JC, Volkmann MR, Koppmair M, Rackwitz L, Ludemann M, Rudert M, Noth U. Comparative retrospective study of the direct anterior and transgluteal approaches for primary total hip arthroplasty. Int Orthop. 2015 Dec;39(12):2309-13. doi: 10.1007/s00264-015-2732-8. Epub 2015 Mar 21.

    PMID: 25795247BACKGROUND

  • Ilchmann T, Gersbach S, Zwicky L, Clauss M. Standard Transgluteal versus Minimal Invasive Anterior Approach in hip Arthroplasty: A Prospective, Consecutive Cohort Study. Orthop Rev (Pavia). 2013 Nov 6;5(4):e31. doi: 10.4081/or.2013.e31. eCollection 2013.

    PMID: 24416475BACKGROUND

  • Yoo JI, Cha YH, Kim KJ, Kim HY, Choy WS, Hwang SC. Gait analysis after total hip arthroplasty using direct anterior approach versus anterolateral approach: a systematic review and meta-analysis. BMC Musculoskelet Disord. 2019 Feb 8;20(1):63. doi: 10.1186/s12891-019-2450-2.

    PMID: 30736783BACKGROUND

Related Links

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2024

First Posted

August 5, 2024

Study Start

January 3, 2021

Primary Completion

June 1, 2023

Study Completion

July 10, 2023

Last Updated

August 5, 2024

Record last verified: 2024-07

Locations

EG(1)