Clinical trial NCT06538519: Gait Analysis and Clinical Outcomes of Anterior and Lateral Approach Total Hip Arthroplasty.
Official title: Gait Analysis and Clinical Outcomes of Anterior and Lateral Approach Total Hip Arthroplasty. A Prospective Randomized Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Osteoarthritis
Keywords: arthroplasty
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-08-05
Enrollment: 34
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: surgery time
timeFrame: intraoperative time starting from skin incision to skin closure
measure: hemoglobin drop
timeFrame: postoperative day one
measure: hospital stays
timeFrame: immediately after the procedure
measure: pain score
timeFrame: 2 weeks 6 weeks 3 months 18 months
measure: Harris hip score
timeFrame: 2 weeks 6 weeks 3 months 18 months
Secondary outcomes:
measure: gait analysis
timeFrame: at 6 weeks, 3 months, 18 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Hospitals
state: Abbasia
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.