HipNCT03850665

Comparison of Functional Outcome in Patients After Hip Arthroplasty Depending on Surgical Approach

A study testing Direct Anterior Approach (DAA) and Anterolateral approach in people with Hip and Osteoarthritis, run by Medical University of Warsaw at 2 sites in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The aim of the study will be to compare functional outcomes of the two surgical hip approaches in total hip arthroplasty: anterior, posterolateral and anterolateral. Surgical approach may have influence on patients functional outcome. Read more about this study

Who is it for?: Ages 50 to 80 years
Conditions the study is for: Hip, Osteoarthritis
What is being tested?: Direct Anterior Approach (DAA) and Anterolateral approach
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 140 participants
Where: 2 sitesPoland
Study dates: 27 Sep 2020to 1 Oct 2021
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 50 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

patient's consent for anticipation in the study
BMI less than 35
ability to walk the distance of 10m and stand up from the chair
arthroplasty in one hip

Who cannot join

patient's lack of consent for anticipation in the study
neurological diseases
balance disorders
reoperations in the area of endoprosthesis
muscles diseases
rheumatic diseases (rheumatoid arthritis, ankylosing spondylitis)
dizziness, vasovagal syncope

Trial locations and contacts

2 sites in 1 country.

Poland2 sites

Department of Orthopedics and Rehabilitation, Medical University of Warsaw
Warsaw, Masovian Voivodeship
Orthopaedics and Rehabilitation Department, Medical University of Warsaw
Warsaw

Other trials in Poland

About this study

Official title: Comparison of Early Objective and Subjective Outcome in Patients After Hip Arthroplasty, Operated From Direct Anterior, Posterolateraland Anterolateral Approach: Prospective Randomized Clinical Trial

Read the detailed description

Patients with primary hip osteoarthritis will be included in a randomized controlled trial and assigned to total hip arthroplasty using one the of hip approaches: anterior or anterolateral. Subjects will be assessed preoperative and 3 and 12 moths postoperative.

Biomechanical gait parameters will be collected using tree-dimensional motion analysis system "BTS SMART".

Evaluation of the function of the middle gluteal muscle with superficial EMG (sEMG) percutaneous surface electromyography. Fatigue assessment (mean frequency and amplitude) of the gluteus medius muscle during isometric muscle contraction.

Balance and coordination as well as fall risk will be assessed with use of dynamometric Biodex Balance platform. The study will determine the values of individual indicators: general stability index (OWS), anterior-posterior stability index (APW), the median lateral stability index (MLW) and the fall risk index (RU).

Subjective assessment will be conducted with use of Visual Analogue Scale, WOMAC Index, Oxford Hip Score, The Short Form-36 (SF-36) and Harris Hip Score

Conditions: Hip, Osteoarthritis
Being tested: Direct Anterior Approach (DAA), Anterolateral approach
Keywords: total, hip, arthroplasty, surgical, approach
Medical subject headings: Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Direct Anterior Approach (DAA)Procedure or surgery
Direct Anterior Approach surgery to replace the hip.
Anterolateral approachProcedure or surgery
Anterolateral approach surgery to replace the hip.

Study groups in NCT03850665
Study group	Role	What they receive
Direct Anterior Approach (DAA)	Active comparator	Direct Anterior Approach surgery to replace the hip. Receives: Procedure: Direct Anterior Approach (DAA); Procedure: Anterolateral approach
Anterolateral approach	Active comparator	Anterolateral Approach surgery to replace the hip. Receives: Procedure: Direct Anterior Approach (DAA); Procedure: Anterolateral approach
Posterolateral approach	Active comparator	Posterolateral Approach surgery to replace the hip. Receives: Procedure: Direct Anterior Approach (DAA); Procedure: Anterolateral approach

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in biomechanical gait parameters
Done by a biomechanics lab for patients to test their hip movements
Measured: from baseline (can be measured anytime to a maximum of one month before surgery) to 3 and 12 months post-operatively
Gluteus medius muscle fatigue
Surface Electromyographic analysis performed for testing gluteus medius activity
Measured: from baseline (can be measured anytime to a maximum of one month before surgery) to 3 and 12 months post-operatively
Change from baseline in Hip disability and Osteoarthritis Outcome Score (HOOS) activities of daily living (ADL)
This asks the patient how their hip functions during their daily life. It has 5 subscales measuring Pain, Symptoms, ADL, Sports/Recreation and Quality of Life (which is calculated using all the subscores). Each subscale is calculated using the mean score, with each score range being from 0 to 4. The subscore is normalized such that the lower the number the more extreme the problem is. To calculate Quality of Life, the mean of the other 4 subscores are taken to calculate the score.
This asks the patient how their hip functions during their daily life. It has 5 subscales measuring Pain, Symptoms, ADL, Sports/Recreation and Quality of Life (which is calculated using all the subscores). Each subscale is calculated using the mean score, with each score range being from 0 to 4. The subscore is normalized such that the lower the number the more extreme the problem is. To calculate Quality of Life, the mean of the other 4 subscores are taken to calculate the score.
Measured: from baseline (can be measured anytime to a maximum of one month before surgery) to 3 and 12 months post-operatively
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
This measures health status as it relates to the hip. There are 3 subscales, pain which score ranges from 0-20, stiffness range from 0-8, physical function ranging from 0-68. The total score is just added up from the subscales.
Measured: from baseline (can be measured anytime to a maximum of one month before surgery) to 3 and 12 months post-operatively
Change in Oxford scale
The Oxford scale is a physiotherapist objective-rated scale to asses muscle strength against the resistance. It is graded from 0 (flicker of movement) to 5 (Through full range actively against strong resistance)
Measured: from baseline (can be measured anytime to a maximum of one month before surgery) to 3 and 12 months post-operatively
Change in SF-36 scale
The SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The vitality sub-score assesses energy and fatigue, and ranges from 0 (worst) - 100 (best).
Measured: from baseline (can be measured anytime to a maximum of one month before surgery) to 3 and 12 months post-operatively
Change in Visual Analog Scale (VAS) scale
To measure pain. This is a line with left most end representing no pain with the rightmost representing extreme pain. The participant puts a line where they feel that day and it is measured with a ruler to determine score out of 100. The line is 100mm long.
Measured: from baseline (can be measured anytime to a maximum of one month before surgery) to 3 and 12 months post-operatively
Change in biomechanical gait balance
Done by a biomechanics lab for patients to test their gait balance
Measured: from baseline (can be measured anytime to a maximum of one month before surgery) to 3 and 12 months post-operatively
Change in biomechanical coordination
Done by a biomechanics lab for patients to test their hip movements coordination
Measured: from baseline (can be measured anytime to a maximum of one month before surgery) to 3 and 12 months post-operatively

Secondary outcomes (1)

Radiological analysis of implants positioning
To measure angles associated with proper implants positioning
Measured: from baseline (can be measured anytime to a maximum of one month before surgery) to 3 and 12 months post-operatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Sep 20201 Oct 2021

First posted22 Feb 2019
Study start27 Sep 2020
Primary completion1 Sep 2021
Study completion1 Oct 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (17)Papers the sponsor has linked to this study.
Other trials for HipStudies of the same condition, open and under way.
More trials run by Medical University of WarsawThe 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: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 140 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03850665
Sponsor's protocol ID: THA/ Warsaw MU
Status last verified: Oct 2021
First submitted: 15 Sep 2018
Last updated: 6 Oct 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Mariconda M, Galasso O, Costa GG, Recano P, Cerbasi S. Quality of life and functionality after total hip arthroplasty: a long-term follow-up study. BMC Musculoskelet Disord. 2011 Oct 6;12:222. doi: 10.1186/1471-2474-12-222.
PubMed 21978244
Sinha A, Twycross-Lewis R, Small C, Morrissey D, Maffulli N. Motion analysis as an outcome measure for hip arthroplasty. Surgeon. 2011 Oct;9(5):284-91. doi: 10.1016/j.surge.2011.02.002. Epub 2011 Mar 13.
PubMed 21843824
Demos HA, Rorabeck CH, Bourne RB, MacDonald SJ, McCalden RW. Instability in primary total hip arthroplasty with the direct lateral approach. Clin Orthop Relat Res. 2001 Dec;(393):168-80. doi: 10.1097/00003086-200112000-00020.
PubMed 11764347
Wylde V, Blom AW, Bolink S, Brunton L, Dieppe P, Gooberman-Hill R, Grimm B, Mann C, Lenguerrand E. Assessing function in patients undergoing joint replacement: a study protocol for a cohort study. BMC Musculoskelet Disord. 2012 Nov 13;13:220. doi: 10.1186/1471-2474-13-220.
PubMed 23148591
Cheng TE, Wallis JA, Taylor NF, Holden CT, Marks P, Smith CL, Armstrong MS, Singh PJ. A Prospective Randomized Clinical Trial in Total Hip Arthroplasty-Comparing Early Results Between the Direct Anterior Approach and the Posterior Approach. J Arthroplasty. 2017 Mar;32(3):883-890. doi: 10.1016/j.arth.2016.08.027. Epub 2016 Aug 31.
PubMed 27687805
Queen RM, Schaeffer JF, Butler RJ, Berasi CC, Kelley SS, Attarian DE, Bolognesi MP. Does surgical approach during total hip arthroplasty alter gait recovery during the first year following surgery? J Arthroplasty. 2013 Oct;28(9):1639-43. doi: 10.1016/j.arth.2013.02.008. Epub 2013 Mar 19.
PubMed 23518430
Wesseling M, Meyer C, Corten K, Simon JP, Desloovere K, Jonkers I. Does surgical approach or prosthesis type affect hip joint loading one year after surgery? Gait Posture. 2016 Feb;44:74-82. doi: 10.1016/j.gaitpost.2015.11.009. Epub 2015 Nov 23.
PubMed 27004636
Foucher KC, Wimmer MA, Moisio KC, Hildebrand M, Berli MC, Walker MR, Berger RA, Galante JO. Time course and extent of functional recovery during the first postoperative year after minimally invasive total hip arthroplasty with two different surgical approaches--a randomized controlled trial. J Biomech. 2011 Feb 3;44(3):372-8. doi: 10.1016/j.jbiomech.2010.10.026. Epub 2010 Nov 13.
PubMed 21075378
Rosenlund S, Broeng L, Overgaard S, Jensen C, Holsgaard-Larsen A. The efficacy of modified direct lateral versus posterior approach on gait function and hip muscle strength after primary total hip arthroplasty at 12months follow-up. An explorative randomised controlled trial. Clin Biomech (Bristol). 2016 Nov;39:91-99. doi: 10.1016/j.clinbiomech.2016.09.011. Epub 2016 Sep 30.
PubMed 27721093
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.
PubMed 26683920
Beaulieu ML, Lamontagne M, Beaule PE. Lower limb biomechanics during gait do not return to normal following total hip arthroplasty. Gait Posture. 2010 Jun;32(2):269-73. doi: 10.1016/j.gaitpost.2010.05.007. Epub 2010 Jun 11.
PubMed 20541940
Bennett D, Humphreys L, O'Brien S, Kelly C, Orr JF, Beverland DE. Gait kinematics of age-stratified hip replacement patients--a large scale, long-term follow-up study. Gait Posture. 2008 Aug;28(2):194-200. doi: 10.1016/j.gaitpost.2007.11.010. Epub 2008 Feb 19.
PubMed 18242996
Calo L, Rabini A, Picciotti PM, Laurino S, Passali GC, Ferrara PE, Maggi L, Piazzini DB, Specchia A, Frasca G, Ronconi G, Bertolini C, Scarano E. Postural control in patients with total hip replacement. Eur J Phys Rehabil Med. 2009 Sep;45(3):327-34. Epub 2009 Feb 11.
PubMed 19209135
Soderman P, Malchau H, Herberts P. Outcome of total hip replacement: a comparison of different measurement methods. Clin Orthop Relat Res. 2001 Sep;(390):163-72. doi: 10.1097/00003086-200109000-00019.
PubMed 11550862
McConnell S, Kolopack P, Davis AM. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): a review of its utility and measurement properties. Arthritis Rheum. 2001 Oct;45(5):453-61. doi: 10.1002/1529-0131(200110)45:53.0.co;2-w. No abstract available.
PubMed 11642645

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Hip trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Early Objective and Subjective Outcome in Patients After Hip Arthroplasty, Operated From Direct Anterior, Posterolateraland Anterolateral Approach: Prospective Randomized Clinical Trial
ClinicalTrials.gov ID: NCT03850665
Acronym / sponsor ID: THA/ Warsaw MU
Conditions: Hip, Osteoarthritis
Keywords: total, hip, arthroplasty, surgical, approach
Study type: Interventional
Recruitment status: Completed
Enrolment: 140 participants (actual)
Lead sponsor: Medical University of WarsawUniversity, hospital or other
Study start: 27 Sep 2020 (actual)
Primary completion: 1 Sep 2021 (actual)
Study completion: 1 Oct 2021 (actual)
First posted: 22 Feb 2019 (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.

Detailed description

Biomechanical gait parameters will be collected using tree-dimensional motion analysis system "BTS SMART".

Subjective assessment will be conducted with use of Visual Analogue Scale, WOMAC Index, Oxford Hip Score, The Short Form-36 (SF-36) and Harris Hip Score

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Direct Anterior Approach (DAA)	Active comparator	Procedure: Direct Anterior Approach (DAA), Procedure: Anterolateral approachDirect Anterior Approach surgery to replace the hip.
Anterolateral approach	Active comparator	Procedure: Direct Anterior Approach (DAA), Procedure: Anterolateral approachAnterolateral Approach surgery to replace the hip.
Posterolateral approach	Active comparator	Procedure: Direct Anterior Approach (DAA), Procedure: Anterolateral approachPosterolateral Approach surgery to replace the hip.

Who may qualify

Ages: 50 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

patient's consent for anticipation in the study
BMI less than 35
ability to walk the distance of 10m and stand up from the chair
arthroplasty in one hip

Key exclusion criteria (7 listed)

patient's lack of consent for anticipation in the study
neurological diseases
balance disorders
reoperations in the area of endoprosthesis
muscles diseases

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
Direct Anterior Approach (DAA)Direct Anterior Approach surgery to replace the hip.	Procedure or surgery	Anterolateral approach, Direct Anterior Approach (DAA), Posterolateral approach
Anterolateral approachAnterolateral approach surgery to replace the hip.	Procedure or surgery	Anterolateral approach, Direct Anterior Approach (DAA), Posterolateral approach

Primary outcome

Change in biomechanical gait parameters
Time frame: from baseline (can be measured anytime to a maximum of one month before surgery) to 3 and 12 months post-operatively
Done by a biomechanics lab for patients to test their hip movements
Gluteus medius muscle fatigue
Time frame: from baseline (can be measured anytime to a maximum of one month before surgery) to 3 and 12 months post-operatively
Surface Electromyographic analysis performed for testing gluteus medius activity
Change from baseline in Hip disability and Osteoarthritis Outcome Score (HOOS) activities of daily living (ADL)
Time frame: from baseline (can be measured anytime to a maximum of one month before surgery) to 3 and 12 months post-operatively
This asks the patient how their hip functions during their daily life. It has 5 subscales measuring Pain, Symptoms, ADL, Sports/Recreation and Quality of Life (which is calculated using all the subscores). Each subscale is calculated using the mean score, with each score range being from 0 to 4. The subscore is normalized such that the lower the number the more extreme the problem is. To calculate Quality of Life, the mean of the other 4 subscores are taken to calculate the score. This asks the patient how their hip functions during their daily life. It has 5 subscales measuring Pain, Symptoms, ADL, Sports/Recreation and Quality of Life (which is calculated using all the subscores). Each subscale is calculated using the mean score, with each score range being from 0 to 4. The subscore is normalized such that the lower the number the more extreme the problem is. To calculate Quality of Life, the mean of the other 4 subscores are taken to calculate the score.
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: from baseline (can be measured anytime to a maximum of one month before surgery) to 3 and 12 months post-operatively
This measures health status as it relates to the hip. There are 3 subscales, pain which score ranges from 0-20, stiffness range from 0-8, physical function ranging from 0-68. The total score is just added up from the subscales.
Change in Oxford scale
Time frame: from baseline (can be measured anytime to a maximum of one month before surgery) to 3 and 12 months post-operatively
The Oxford scale is a physiotherapist objective-rated scale to asses muscle strength against the resistance. It is graded from 0 (flicker of movement) to 5 (Through full range actively against strong resistance)
Change in SF-36 scale
Time frame: from baseline (can be measured anytime to a maximum of one month before surgery) to 3 and 12 months post-operatively
The SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The vitality sub-score assesses energy and fatigue, and ranges from 0 (worst) - 100 (best).
Change in Visual Analog Scale (VAS) scale
Time frame: from baseline (can be measured anytime to a maximum of one month before surgery) to 3 and 12 months post-operatively
To measure pain. This is a line with left most end representing no pain with the rightmost representing extreme pain. The participant puts a line where they feel that day and it is measured with a ruler to determine score out of 100. The line is 100mm long.
Change in biomechanical gait balance
Time frame: from baseline (can be measured anytime to a maximum of one month before surgery) to 3 and 12 months post-operatively
Done by a biomechanics lab for patients to test their gait balance
Change in biomechanical coordination
Time frame: from baseline (can be measured anytime to a maximum of one month before surgery) to 3 and 12 months post-operatively
Done by a biomechanics lab for patients to test their hip movements coordination

1 secondary outcome

Radiological analysis of implants positioning
Time frame: from baseline (can be measured anytime to a maximum of one month before surgery) to 3 and 12 months post-operatively

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 6 Oct 2021.
Background: PubMed 21978244Mariconda M, Galasso O, Costa GG, Recano P, Cerbasi S. Quality of life and functionality after total hip arthroplasty: a long-term follow-up study. BMC Musculoskelet Disord. 2011 Oct 6;12:222. doi: 10.1186/1471-2474-12-222.
Background: PubMed 21843824Sinha A, Twycross-Lewis R, Small C, Morrissey D, Maffulli N. Motion analysis as an outcome measure for hip arthroplasty. Surgeon. 2011 Oct;9(5):284-91. doi: 10.1016/j.surge.2011.02.002. Epub 2011 Mar 13.
Background: PubMed 11764347Demos HA, Rorabeck CH, Bourne RB, MacDonald SJ, McCalden RW. Instability in primary total hip arthroplasty with the direct lateral approach. Clin Orthop Relat Res. 2001 Dec;(393):168-80. doi: 10.1097/00003086-200112000-00020.
Background: PubMed 23148591Wylde V, Blom AW, Bolink S, Brunton L, Dieppe P, Gooberman-Hill R, Grimm B, Mann C, Lenguerrand E. Assessing function in patients undergoing joint replacement: a study protocol for a cohort study. BMC Musculoskelet Disord. 2012 Nov 13;13:220. doi: 10.1186/1471-2474-13-220.
Background: PubMed 27687805Cheng TE, Wallis JA, Taylor NF, Holden CT, Marks P, Smith CL, Armstrong MS, Singh PJ. A Prospective Randomized Clinical Trial in Total Hip Arthroplasty-Comparing Early Results Between the Direct Anterior Approach and the Posterior Approach. J Arthroplasty. 2017 Mar;32(3):883-890. doi: 10.1016/j.arth.2016.08.027. Epub 2016 Aug 31.
Background: PubMed 23518430Queen RM, Schaeffer JF, Butler RJ, Berasi CC, Kelley SS, Attarian DE, Bolognesi MP. Does surgical approach during total hip arthroplasty alter gait recovery during the first year following surgery? J Arthroplasty. 2013 Oct;28(9):1639-43. doi: 10.1016/j.arth.2013.02.008. Epub 2013 Mar 19.
Background: PubMed 27004636Wesseling M, Meyer C, Corten K, Simon JP, Desloovere K, Jonkers I. Does surgical approach or prosthesis type affect hip joint loading one year after surgery? Gait Posture. 2016 Feb;44:74-82. doi: 10.1016/j.gaitpost.2015.11.009. Epub 2015 Nov 23.
Background: PubMed 21075378Foucher KC, Wimmer MA, Moisio KC, Hildebrand M, Berli MC, Walker MR, Berger RA, Galante JO. Time course and extent of functional recovery during the first postoperative year after minimally invasive total hip arthroplasty with two different surgical approaches--a randomized controlled trial. J Biomech. 2011 Feb 3;44(3):372-8. doi: 10.1016/j.jbiomech.2010.10.026. Epub 2010 Nov 13.
Background: PubMed 27721093Rosenlund S, Broeng L, Overgaard S, Jensen C, Holsgaard-Larsen A. The efficacy of modified direct lateral versus posterior approach on gait function and hip muscle strength after primary total hip arthroplasty at 12months follow-up. An explorative randomised controlled trial. Clin Biomech (Bristol). 2016 Nov;39:91-99. doi: 10.1016/j.clinbiomech.2016.09.011. Epub 2016 Sep 30.
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 20541940Beaulieu ML, Lamontagne M, Beaule PE. Lower limb biomechanics during gait do not return to normal following total hip arthroplasty. Gait Posture. 2010 Jun;32(2):269-73. doi: 10.1016/j.gaitpost.2010.05.007. Epub 2010 Jun 11.
Background: PubMed 18242996Bennett D, Humphreys L, O'Brien S, Kelly C, Orr JF, Beverland DE. Gait kinematics of age-stratified hip replacement patients--a large scale, long-term follow-up study. Gait Posture. 2008 Aug;28(2):194-200. doi: 10.1016/j.gaitpost.2007.11.010. Epub 2008 Feb 19.

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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.

Artur Stolarczyk, Ph. D study director

Orthopaedics and Rehabilitation Department, Medical University of Warsaw

Bartosz Maciąg principal investigator

Orthopaedics and Rehabilitation Department, Medical University of Warsaw

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Direct Anterior Approach (DAA) and Anterolateral approach in people with Hip and Osteoarthritis, run by Medical University of Warsaw at 2 sites in Poland.

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 4 inclusion and 7 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 6 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Poland. 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?

Change in biomechanical gait parameters (time frame: from baseline (can be measured anytime to a maximum of one month before surgery) to 3 and 12 months post-operatively). The study lists 9 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 NCT03850665, which also lists 17 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 6 Oct 2021.