Gait Analysis and Clinical Outcomes of Anterior and Lateral Approach Total Hip Arthroplasty.

Gait Analysis and Clinical Outcomes of Anterior and Lateral Approach Total Hip Arthroplasty. A Prospective Randomized Study.

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.

Study Overview

• Status: Completed
• Conditions: Hip Osteoarthritis
• Intervention / Treatment: Procedure: total hip replacement using anterior approach; Device: gait analysis at 6wks, 3 months and 18 months; Procedure: total hip replacement using lateral approach

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Abbasia
    • Cairo, Abbasia, Egypt
      • Ain Shams University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: lateral approach group	Device: gait analysis at 6wks, 3 months and 18 months; gait analysis done in the gait lab at the mentioned postoperative periods; Procedure: total hip replacement using lateral approach; In the lateral approach partial detachment of the anterior one-third of the gluteus medius muscle.
Active Comparator: direct anterior approach group	Procedure: total hip replacement using anterior approach; the anterior approach using an internervous plane between the tensor fascia latae and the sartorius muscle.; Device: gait analysis at 6wks, 3 months and 18 months; gait analysis done in the gait lab at the mentioned postoperative periods

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
gait analysis	A single experienced physical medicine specialist will perform the gait analysis in a gait lab. Three-dimensional kinematic and kinetic data will be collected using eight high-speed infrared cameras (Quality motion analysis system, oqus 1 cameras), which can capture 240 frames per second, two force plates (Advanced Mechanical Technology Incorporated, AMTI), and 26 ten-millimeter passive retroreflective markers fixed on the subject using a double-face tape in specific landmarks on the subject in accordance to the modified institute Orthopedic Rizzoli (IOR ) model for full body marker set.	at 6 weeks, 3 months, 18 months

Collaborators and Investigators

• Sponsor: Ain Shams University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Helpful Links

• Gait analysis after total hip arthroplasty using direct anterior approach versus anterolateral approach: a systematic review and meta-analysis

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2021
• Primary Completion (Actual): June 1, 2023
• Study Completion (Actual): July 10, 2023

Study Registration Dates

• First Submitted: July 7, 2024
• First Submitted That Met QC Criteria: August 2, 2024
• First Posted (Estimated): August 5, 2024

Study Record Updates

• Last Update Posted (Estimated): August 5, 2024
• Last Update Submitted That Met QC Criteria: August 2, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: arthroplasty
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Hip
• Other Study ID Numbers: MD 03/2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No