Knee OsteoarthritisNCT04244838
Gait Analysis in Patients Underwent Total Knee Arthroplasty With a Medial Pivot Design.
A study testing Gait Analysis in people with Knee Osteoarthritis, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
The purpose of the present pilot study is to evaluate, through gait analysis and rating scales, the functional outcome during the execution of motor tasks with high functional demand such as walking on an unstable surface, stair ascent and descent, maximal knee flexion under load (lunge) on a sample of 20 subjects… Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Gait Analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteItaly
- Study dates
- 29 Jul 2019to 19 May 2024
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 50-75 years of both gender
- Patients with three-compartment knee arthrosis (primary or secondary post-traumatic)
- Patients with femoral or tibial osteonecrosis
- Patients with posterior cruciate ligament and healthy collateral ligaments at the level of the affected knee
- Deformity in varus or valgus inferior to 10 °
- Person able to provide informed consent and who agrees to sign the Informed Consent Form approved by the Ethics Committee (EC).
- Subject compliant with post-operative rehabilitation to be performed according to normal clinical practice
Who cannot join
- Patients with severe morphostructural alterations or other pathologies affecting the knee and lower limb
- Patients with serious systemic vascular and neurological pathologies
- Obese or body mass index BMI> 30 kg / m2
- Patients with posterior cruciate ligament and / or collateral ligaments injury in the affected knee
- Knee arthroplasty in the contralateral
- Patient not compliant with post-operative rehabilitation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Biomechanical Functional Evaluation Through Gait Analysis in Patients Underwent Total Knee Arthroplasty With a Medial Pivot Design: Pilot Study
The purpose of the present pilot study is to evaluate, through gait analysis and rating scales, the functional outcome during the execution of motor tasks with high functional demand such as walking on an unstable surface, stair ascent and descent, maximal knee flexion under load (lunge) on a sample of 20 subjects candidates to cemented total knee arthroplasty with MP design at the Orthopedic and Traumatology Clinic 2nd of the Rizzoli Orthopedic Institute. The parameters obtained will be compared with the parameters of healthy subjects comparable by age and Body Max Index (BMI) already acquired at the Movement Analysis Laboratory of the Rizzoli Orthopedic Institute, where the study will be conducted.
On the day of admission to the ward (generally the day before the scheduled surgery), the enrolled patients will undergo the evaluation scales and gait analysis at the Institute's Movement Analysis Laboratory.
Read more
The patients will be operated by the team of the Traumatological Orthopedic Clinic 2nd through the implantation of a cemented total knee prosthesis MP (Evolution medial-pivot knee system, MicroPort Orthopedics). Anterior knee access with medial para-patellar capsulotomy and standard instruments will be used according to current standards of good clinical practice.
In the post-operative period, patients will carry out post-surgical rehabilitation following normal clinical practice.
The patients will be re-evaluated at a 6-month follow-up through gait analysis and evaluation scales on the occasion of the control visit that takes place, according to the normal clinical practice at the Institute.
Read the detailed description
Total knee prosthesis (PTG) is a widespread surgical procedure that aims to treat severe knee osteoarthritis. This type of intervention has proved successful in reducing chronic pain caused by osteoarthritis and in improving the motor performance of the operated subject as well as the quality of life even if the functional outcome after this procedure is still limited, especially in the execution of more complex and demanding motor tasks (e.g. climbing and descending stairs, walking on unstable surfaces, maximum knee flexion under load) due to the difficulty in finding a prosthetic design that mimics the natural joint biomechanics of a non-arthrosic knee.
Medial Pivot (MP) knee prostheses have been designed to meet these requirements by replicating the morphology of the healthy knee, characterized by a medial compartment with a stable conformation and a movable lateral compartment that moves by rotating around the pivot point. Despite the theoretical premises of this prosthetic model, in literature very few studies have investigated how the MP design translates into an improvement of the functional outcome of the subject operated during the journey, while no study has ever been conducted to evaluate the functional outcome during the execution of more demanding motor tasks although the subjects who undergo knee arthroplasty are always younger and more and more active, with increasingly higher functional needs. To date, gait analysis, a non-invasive functional assessment method that provides objective and quantitative data about spatio-temporal parameters, kinematics, kinetics and muscle activation, represents the Gold Standard for the assessment of functional outcome both in healthy patients and in patients subjected to prosthetic surgery.
The purpose of the present pilot study is to evaluate, through gait analysis and rating scales, the functional outcome during the execution of motor tasks with high functional demand such as walking on an unstable surface, stair ascent and descent, maximal knee flexion under load (lunge) on a sample of 20 subjects candidates to cemented total knee arthroplasty with MP design at the Orthopedic and Traumatology Clinic 2nd of the Rizzoli Orthopedic Institute. The parameters obtained will be compared with the parameters of healthy subjects comparable by age and Body Max Index (BMI) already acquired at the Movement Analysis Laboratory of the Rizzoli Orthopedic Institute, where the study will be conducted.
The pilot study is necessary to carry out a preliminary assessment of the functional outcome and joint biomechanics of the knee prosthesis with the gait analysis method never performed in other studies during the execution of demanding motor tasks, with high functional demand. The collection of information and data obtained will allow the appropriate calculation of the sample useful for a subsequent study.
During the pre-hospitalization visit, participation in the study will be proposed to those who meet the inclusion criteria. If the subject accepts, he will be recruited and will have to sign the informed consent to the study.
On the day of admission to the ward (generally the day before the scheduled surgery), the enrolled patients will undergo the evaluation scales and gait analysis at the Institute's Movement Analysis Laboratory.
The patients will be operated by the team of the Traumatological Orthopedic Clinic 2nd through the implantation of a cemented total knee prosthesis MP (Evolution medial-pivot knee system, MicroPort Orthopedics). Anterior knee access with medial para-patellar capsulotomy and standard instruments will be used according to current standards of good clinical practice.
In the post-operative period, patients will carry out post-surgical rehabilitation following normal clinical practice.
The patients will be re-evaluated at a 6-month follow-up through gait analysis and evaluation scales on the occasion of the control visit that takes place, according to the normal clinical practice at the Institute.
- Conditions
- Knee Osteoarthritis
- Being tested
- Gait Analysis
- Keywords
- Medially stabilized total knee arthroplasty, In vivo kinematics, gait analysis
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait AnalysisDiagnostic test
The patients will undergo Gait analysis (integrated movement analysis system) performed at the Complex Laboratory for Movement Analysis and functional-clinical evaluation of the prosthesis of the Rizzoli Orthopedic Institute. The instrumentation used in the Movement Analysis Laboratory consists of a stereophotogrammetric system equipped with eight infrared cameras (Vicon® 460-Oxford system) and 2 dynamometric platforms (Kistler® Instrument, AG Switzerland). The IOR GAIT protocol will be used as a marker set (Leardini et al. 2007). For the evaluation of muscle activation, surface electromyography with 16-channel system will be used (ZeroWire Cometa, Milan). Spatio-temporal parameters, kinematics, kinetics and muscle activation will be evaluated.
| Study group | Role | What they receive |
|---|---|---|
| MP-TKA group | Experimental | 20 patients candidates for cemented TKA with MP design for tri-compartment gonarthrosis will be recruited on indications of the surgeon and according to normal clinical practice at the Orthopedic and Traumatological Clinic 2nd of the Rizzoli Orthopedic Institute. Receives: Diagnostic Test: Gait Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait analysis
Spatio-temporal parameters, kinematics of pelvis, hip, knee and ankle in the sagittal coronal and transverse planes, kinetics (joint moments and foot-soil reaction forces), rectus femoral muscle activation, biceps femoris, anterior tibialis, medial twin during the path, ascent and descent from stairs, lunge, path on unstable surface
Measured: 20 months
American Knee Society Score
It is used to assess knee functionality by investigator. It consists of both a clinical and a functional score
Measured: 22 months
Knee injury and Osteoarthritis Outcome Score
KOOS is a valid, reliable and responsive self-administered instrument that can be used for short-term and long-term follow-up of several types of knee injury including osteoarthritis.
It consists of five separately scored subscales: Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QoL).
Measured: 22 months
Visual analogue scale
It is used for subjective pain evaluation
Measured: 22 months
Short Form-36
36 items presented in eight dimensions (physical activity, monitoring of the role due to physical health, emotional state, physical pain, perception of the general state of health, vitality, social activities and mental health).
Measured: 22 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start29 Jul 2019
- Primary completion19 May 2024
- Study completion19 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giulio Maria Marcheggiani Muccioli, MD, PhD, Principal investigator, IRCCS Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04244838
- Sponsor's protocol ID
- MP-TKA-GAIT
- Status last verified
- Sep 2024
- First submitted
- 20 Jan 2020
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alnahdi AH, Zeni JA, Snyder-Mackler L. Gait after unilateral total knee arthroplasty: frontal plane analysis. J Orthop Res. 2011 May;29(5):647-52. doi: 10.1002/jor.21323. Epub 2010 Dec 23.
PubMed 21437943Benjamin B, Pietrzak JRT, Tahmassebi J, Haddad FS. A functional comparison of medial pivot and condylar knee designs based on patient outcomes and parameters of gait. Bone Joint J. 2018 Jan;100-B(1 Supple A):76-82. doi: 10.1302/0301-620X.100B1.BJJ-2017-0605.R1.
PubMed 29292344Hatfield GL, Hubley-Kozey CL, Astephen Wilson JL, Dunbar MJ. The effect of total knee arthroplasty on knee joint kinematics and kinetics during gait. J Arthroplasty. 2011 Feb;26(2):309-18. doi: 10.1016/j.arth.2010.03.021. Epub 2010 May 31.
PubMed 20570095Hubley-Kozey CL, Hatfield GL, Astephen Wilson JL, Dunbar MJ. Alterations in neuromuscular patterns between pre and one-year post-total knee arthroplasty. Clin Biomech (Bristol). 2010 Dec;25(10):995-1002. doi: 10.1016/j.clinbiomech.2010.07.008. Epub 2010 Aug 21.
PubMed 20728970Leardini A, Sawacha Z, Paolini G, Ingrosso S, Nativo R, Benedetti MG. A new anatomically based protocol for gait analysis in children. Gait Posture. 2007 Oct;26(4):560-71. doi: 10.1016/j.gaitpost.2006.12.018. Epub 2007 Feb 8.
PubMed 17291764Levinger P, Menz HB, Morrow AD, Perrott MA, Bartlett JR, Feller JA, Bergman NB. Knee biomechanics early after knee replacement surgery predict abnormal gait patterns 12 months postoperatively. J Orthop Res. 2012 Mar;30(3):371-6. doi: 10.1002/jor.21545. Epub 2011 Sep 1.
PubMed 21887700McIntosh AS, Beatty KT, Dwan LN, Vickers DR. Gait dynamics on an inclined walkway. J Biomech. 2006;39(13):2491-502. doi: 10.1016/j.jbiomech.2005.07.025. Epub 2005 Sep 15.
PubMed 16169000Moonot P, Mu S, Railton GT, Field RE, Banks SA. Tibiofemoral kinematic analysis of knee flexion for a medial pivot knee. Knee Surg Sports Traumatol Arthrosc. 2009 Aug;17(8):927-34. doi: 10.1007/s00167-009-0777-1. Epub 2009 Mar 31.
PubMed 19333579Naal FD, Fischer M, Preuss A, Goldhahn J, von Knoch F, Preiss S, Munzinger U, Drobny T. Return to sports and recreational activity after unicompartmental knee arthroplasty. Am J Sports Med. 2007 Oct;35(10):1688-95. doi: 10.1177/0363546507303562. Epub 2007 Jun 8.
PubMed 17557876
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomechanical Functional Evaluation Through Gait Analysis in Patients Underwent Total Knee Arthroplasty With a Medial Pivot Design: Pilot Study
- ClinicalTrials.gov ID
- NCT04244838
- Acronym / sponsor ID
- MP-TKA-GAIT
- Conditions
- Knee Osteoarthritis
- Keywords
- Medially stabilized total knee arthroplasty, In vivo kinematics, gait analysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 29 Jul 2019 (actual)
- Primary completion
- 19 May 2024 (actual)
- Study completion
- 19 May 2024 (actual)
- First posted
- 28 Jan 2020 (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 purpose of the present pilot study is to evaluate, through gait analysis and rating scales, the functional outcome during the execution of motor tasks with high functional demand such as walking on an unstable surface, stair ascent and descent, maximal knee flexion under load (lunge) on a sample of 20 subjects candidates to cemented total knee arthroplasty with MP design at the Orthopedic and Traumatology Clinic 2nd of the Rizzoli Orthopedic Institute. The parameters obtained will be compared with the parameters of healthy subjects comparable by age and Body Max Index (BMI) already acquired at the Movement Analysis Laboratory of the Rizzoli Orthopedic Institute, where the study will be conducted.
On the day of admission to the ward (generally the day before the scheduled surgery), the enrolled patients will undergo the evaluation scales and gait analysis at the Institute's Movement Analysis Laboratory.
The patients will be operated by the team of the Traumatological Orthopedic Clinic 2nd through the implantation of a cemented total knee prosthesis MP (Evolution medial-pivot knee system, MicroPort Orthopedics). Anterior knee access with medial para-patellar capsulotomy and standard instruments will be used according to current standards of good clinical practice.
In the post-operative period, patients will carry out post-surgical rehabilitation following normal clinical practice.
The patients will be re-evaluated at a 6-month follow-up through gait analysis and evaluation scales on the occasion of the control visit that takes place, according to the normal clinical practice at the Institute.
Detailed description
Total knee prosthesis (PTG) is a widespread surgical procedure that aims to treat severe knee osteoarthritis. This type of intervention has proved successful in reducing chronic pain caused by osteoarthritis and in improving the motor performance of the operated subject as well as the quality of life even if the functional outcome after this procedure is still limited, especially in the execution of more complex and demanding motor tasks (e.g. climbing and descending stairs, walking on unstable surfaces, maximum knee flexion under load) due to the difficulty in finding a prosthetic design that mimics the natural joint biomechanics of a non-arthrosic knee.
Medial Pivot (MP) knee prostheses have been designed to meet these requirements by replicating the morphology of the healthy knee, characterized by a medial compartment with a stable conformation and a movable lateral compartment that moves by rotating around the pivot point. Despite the theoretical premises of this prosthetic model, in literature very few studies have investigated how the MP design translates into an improvement of the functional outcome of the subject operated during the journey, while no study has ever been conducted to evaluate the functional outcome during the execution of more demanding motor tasks although the subjects who undergo knee arthroplasty are always younger and more and more active, with increasingly higher functional needs. To date, gait analysis, a non-invasive functional assessment method that provides objective and quantitative data about spatio-temporal parameters, kinematics, kinetics and muscle activation, represents the Gold Standard for the assessment of functional outcome both in healthy patients and in patients subjected to prosthetic surgery.
The purpose of the present pilot study is to evaluate, through gait analysis and rating scales, the functional outcome during the execution of motor tasks with high functional demand such as walking on an unstable surface, stair ascent and descent, maximal knee flexion under load (lunge) on a sample of 20 subjects candidates to cemented total knee arthroplasty with MP design at the Orthopedic and Traumatology Clinic 2nd of the Rizzoli Orthopedic Institute. The parameters obtained will be compared with the parameters of healthy subjects comparable by age and Body Max Index (BMI) already acquired at the Movement Analysis Laboratory of the Rizzoli Orthopedic Institute, where the study will be conducted.
The pilot study is necessary to carry out a preliminary assessment of the functional outcome and joint biomechanics of the knee prosthesis with the gait analysis method never performed in other studies during the execution of demanding motor tasks, with high functional demand. The collection of information and data obtained will allow the appropriate calculation of the sample useful for a subsequent study.
During the pre-hospitalization visit, participation in the study will be proposed to those who meet the inclusion criteria. If the subject accepts, he will be recruited and will have to sign the informed consent to the study.
On the day of admission to the ward (generally the day before the scheduled surgery), the enrolled patients will undergo the evaluation scales and gait analysis at the Institute's Movement Analysis Laboratory.
The patients will be operated by the team of the Traumatological Orthopedic Clinic 2nd through the implantation of a cemented total knee prosthesis MP (Evolution medial-pivot knee system, MicroPort Orthopedics). Anterior knee access with medial para-patellar capsulotomy and standard instruments will be used according to current standards of good clinical practice.
In the post-operative period, patients will carry out post-surgical rehabilitation following normal clinical practice.
The patients will be re-evaluated at a 6-month follow-up through gait analysis and evaluation scales on the occasion of the control visit that takes place, according to the normal clinical practice at the Institute.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MP-TKA group | Experimental | Diagnostic Test: Gait Analysis20 patients candidates for cemented TKA with MP design for tri-compartment gonarthrosis will be recruited on indications of the surgeon and according to normal clinical practice at the Orthopedic and Traumatological Clinic 2nd of the Rizzoli Orthopedic Institute. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age: 50-75 years of both gender
- Patients with three-compartment knee arthrosis (primary or secondary post-traumatic)
- Patients with femoral or tibial osteonecrosis
- Patients with posterior cruciate ligament and healthy collateral ligaments at the level of the affected knee
- Deformity in varus or valgus inferior to 10 °
Key exclusion criteria (6 listed)
- Patients with severe morphostructural alterations or other pathologies affecting the knee and lower limb
- Patients with serious systemic vascular and neurological pathologies
- Obese or body mass index BMI> 30 kg / m2
- Patients with posterior cruciate ligament and / or collateral ligaments injury in the affected knee
- Knee arthroplasty in the contralateral
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 |
|---|---|---|
| Gait AnalysisThe patients will undergo Gait analysis (integrated movement analysis system) performed at the Complex Laboratory for Movement Analysis and functional-clinical evaluation of the prosthesis of the Rizzoli Orthopedic Institute. The instrumentation used in the Movement Analysis Laboratory consists of a stereophotogrammetric system equipped with eight infrared cameras (Vicon® 460-Oxford system) and 2 dynamometric platforms (Kistler® Instrument, AG Switzerland). The IOR GAIT protocol will be used as a marker set (Leardini et al. 2007). For the evaluation of muscle activation, surface electromyography with 16-channel system will be used (ZeroWire Cometa, Milan). Spatio-temporal parameters, kinematics, kinetics and muscle activation will be evaluated. | Diagnostic test | MP-TKA group |
Primary outcome
Gait analysis
Time frame: 20 months
Spatio-temporal parameters, kinematics of pelvis, hip, knee and ankle in the sagittal coronal and transverse planes, kinetics (joint moments and foot-soil reaction forces), rectus femoral muscle activation, biceps femoris, anterior tibialis, medial twin during the path, ascent and descent from stairs, lunge, path on unstable surface
American Knee Society Score
Time frame: 22 months
It is used to assess knee functionality by investigator. It consists of both a clinical and a functional score
Knee injury and Osteoarthritis Outcome Score
Time frame: 22 months
KOOS is a valid, reliable and responsive self-administered instrument that can be used for short-term and long-term follow-up of several types of knee injury including osteoarthritis. It consists of five separately scored subscales: Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QoL).
Visual analogue scale
Time frame: 22 months
It is used for subjective pain evaluation
Short Form-36
Time frame: 22 months
36 items presented in eight dimensions (physical activity, monitoring of the role due to physical health, emotional state, physical pain, perception of the general state of health, vitality, social activities and mental health).
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 23 Sep 2024.
- Results publication: PubMed 21437943Alnahdi AH, Zeni JA, Snyder-Mackler L. Gait after unilateral total knee arthroplasty: frontal plane analysis. J Orthop Res. 2011 May;29(5):647-52. doi: 10.1002/jor.21323. Epub 2010 Dec 23.
- Results publication: PubMed 29292344Benjamin B, Pietrzak JRT, Tahmassebi J, Haddad FS. A functional comparison of medial pivot and condylar knee designs based on patient outcomes and parameters of gait. Bone Joint J. 2018 Jan;100-B(1 Supple A):76-82. doi: 10.1302/0301-620X.100B1.BJJ-2017-0605.R1.
- Results publication: PubMed 20570095Hatfield GL, Hubley-Kozey CL, Astephen Wilson JL, Dunbar MJ. The effect of total knee arthroplasty on knee joint kinematics and kinetics during gait. J Arthroplasty. 2011 Feb;26(2):309-18. doi: 10.1016/j.arth.2010.03.021. Epub 2010 May 31.
- Results publication: PubMed 20728970Hubley-Kozey CL, Hatfield GL, Astephen Wilson JL, Dunbar MJ. Alterations in neuromuscular patterns between pre and one-year post-total knee arthroplasty. Clin Biomech (Bristol). 2010 Dec;25(10):995-1002. doi: 10.1016/j.clinbiomech.2010.07.008. Epub 2010 Aug 21.
- Results publication: PubMed 17291764Leardini A, Sawacha Z, Paolini G, Ingrosso S, Nativo R, Benedetti MG. A new anatomically based protocol for gait analysis in children. Gait Posture. 2007 Oct;26(4):560-71. doi: 10.1016/j.gaitpost.2006.12.018. Epub 2007 Feb 8.
- Results publication: PubMed 21887700Levinger P, Menz HB, Morrow AD, Perrott MA, Bartlett JR, Feller JA, Bergman NB. Knee biomechanics early after knee replacement surgery predict abnormal gait patterns 12 months postoperatively. J Orthop Res. 2012 Mar;30(3):371-6. doi: 10.1002/jor.21545. Epub 2011 Sep 1.
- Results publication: PubMed 16169000McIntosh AS, Beatty KT, Dwan LN, Vickers DR. Gait dynamics on an inclined walkway. J Biomech. 2006;39(13):2491-502. doi: 10.1016/j.jbiomech.2005.07.025. Epub 2005 Sep 15.
- Results publication: PubMed 19333579Moonot P, Mu S, Railton GT, Field RE, Banks SA. Tibiofemoral kinematic analysis of knee flexion for a medial pivot knee. Knee Surg Sports Traumatol Arthrosc. 2009 Aug;17(8):927-34. doi: 10.1007/s00167-009-0777-1. Epub 2009 Mar 31.
- Results publication: PubMed 17557876Naal FD, Fischer M, Preuss A, Goldhahn J, von Knoch F, Preiss S, Munzinger U, Drobny T. Return to sports and recreational activity after unicompartmental knee arthroplasty. Am J Sports Med. 2007 Oct;35(10):1688-95. doi: 10.1177/0363546507303562. Epub 2007 Jun 8.
- Individual participant dataSharing planned: No
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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.
Giulio Maria Marcheggiani Muccioli, MD, PhD principal investigator
IRCCS Istituto Ortopedico Rizzoli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gait Analysis in people with Knee Osteoarthritis, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
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 7 inclusion and 6 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 23 Sep 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 Italy. 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?
Gait analysis (time frame: 20 months). 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 NCT04244838, which also lists 9 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 23 Sep 2024.