Hip OsteoarthritisNCT06538519
Gait Analysis and Clinical Outcomes of Anterior and Lateral Approach Total Hip Arthroplasty.
A study testing total hip replacement using lateral approach, total hip replacement using anterior approach and gait analysis at 6wks, 3 months and 18 months in people with Hip Osteoarthritis, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Hip Osteoarthritis
- What is being tested?
- total hip replacement using lateral approach, total hip replacement using anterior approach and gait analysis at 6wks, 3 months and 18 months
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Jan 2021to 10 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Hip Osteoarthritis
- Being tested
- total hip replacement using lateral approach, total hip replacement using anterior approach, gait analysis at 6wks, 3 months and 18 months
- Keywords
- arthroplasty
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
total hip replacement using lateral approachProcedure or surgery
In the lateral approach partial detachment of the anterior one-third of the gluteus medius muscle.
total hip replacement using anterior approachProcedure or surgery
the anterior approach using an internervous plane between the tensor fascia latae and the sartorius muscle.
gait analysis at 6wks, 3 months and 18 monthsDevice
gait analysis done in the gait lab at the mentioned postoperative periods
| Study group | Role | What they receive |
|---|---|---|
| direct anterior approach group | Active comparator | Not described Receives: Procedure: total hip replacement using anterior approach; Device: gait analysis at 6wks, 3 months and 18 months |
| lateral approach group | Active comparator | Not described Receives: Procedure: total hip replacement using lateral approach; Device: gait analysis at 6wks, 3 months and 18 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
surgery time
by ''Minute'' as the unit, no special description.
Measured: intraoperative time starting from skin incision to skin closure
hemoglobin drop
hemoglobin drop level between pre and postoperative.
Measured: postoperative day one
hospital stays
by ''Day'' as the unit, no special description. postoperative stay days from operation day to discharge day.
Measured: immediately after the procedure
pain score
using visual analogue scale (VAS) from 0-10 the more scale the worst the pain
Measured: 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
Measured: 2 weeks 6 weeks 3 months 18 months
Secondary outcomes (1)
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.
Measured: at 6 weeks, 3 months, 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start3 Jan 2021
- Primary completion1 Jun 2023
- Study completion10 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Hip OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06538519
- Sponsor's protocol ID
- MD 03/2021
- Status last verified
- Jul 2024
- First submitted
- 7 Jul 2024
- Last updated
- 5 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 30808382Pospischill 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.
PubMed 20124059Yue 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.
PubMed 26683920Graves 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.
PubMed 26620966Alecci 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.
PubMed 21748384Reichert 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.
PubMed 25795247Ilchmann 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.
PubMed 24416475Yoo 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.
PubMed 30736783
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gait Analysis and Clinical Outcomes of Anterior and Lateral Approach Total Hip Arthroplasty. A Prospective Randomized Study.
- ClinicalTrials.gov ID
- NCT06538519
- Acronym / sponsor ID
- MD 03/2021
- Conditions
- Hip Osteoarthritis
- Keywords
- arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 3 Jan 2021 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 10 Jul 2023 (actual)
- First posted
- 5 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| direct anterior approach group | Active comparator | Procedure: total hip replacement using anterior approach, Device: gait analysis at 6wks, 3 months and 18 months |
| lateral approach group | Active comparator | Procedure: total hip replacement using lateral approach, Device: gait analysis at 6wks, 3 months and 18 months |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| total hip replacement using lateral approachIn the lateral approach partial detachment of the anterior one-third of the gluteus medius muscle. | Procedure or surgery | lateral approach group |
| total hip replacement using anterior approachthe anterior approach using an internervous plane between the tensor fascia latae and the sartorius muscle. | Procedure or surgery | direct anterior approach group |
| gait analysis at 6wks, 3 months and 18 monthsgait analysis done in the gait lab at the mentioned postoperative periods | Device | direct anterior approach group, lateral approach group |
Primary outcome
surgery time
Time frame: intraoperative time starting from skin incision to skin closure
by ''Minute'' as the unit, no special description.
hemoglobin drop
Time frame: postoperative day one
hemoglobin drop level between pre and postoperative.
hospital stays
Time frame: immediately after the procedure
by ''Day'' as the unit, no special description. postoperative stay days from operation day to discharge day.
pain score
Time frame: 2 weeks 6 weeks 3 months 18 months
using visual analogue scale (VAS) from 0-10 the more scale the worst the pain
Harris hip score
Time frame: 2 weeks 6 weeks 3 months 18 months
for measuring hip function from 0-100 the more the score the better hip function
1 secondary outcome
gait analysis
Time frame: at 6 weeks, 3 months, 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2024.
- Background: PubMed 30808382Wang 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.
- Background: PubMed 20124059Pospischill 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.
- Background: PubMed 26683920Yue 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.
- Background: PubMed 26620966Graves 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.
- Background: PubMed 21748384Alecci 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.
- Background: PubMed 25795247Reichert 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.
- Background: PubMed 24416475Ilchmann 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.
- Background: PubMed 30736783Yoo 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.
- Gait analysis after total hip arthroplasty using direct anterior approach versus anterolateral approach: a systematic review and meta-analysisLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing total hip replacement using lateral approach, total hip replacement using anterior approach and gait analysis at 6wks, 3 months and 18 months in people with Hip Osteoarthritis, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
surgery time (time frame: intraoperative time starting from skin incision to skin closure). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06538519, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2024.