Lower Limb DeformityNCT05576064
Is Gait Analysis for Proposed Rotational Deformities a Useful Resource
An observational study of Lower Limb Deformity and Anterior Knee Pain Syndrome, run by Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust at 1 site in United Kingdom.
Trial summary
Rotational deformities, such as femoral (thigh bone) and tibial (leg bone) torsion, are established causes of patellofemoral (kneecap joint) pain and instability. Currently, computerized tomography (CT) remains the gold standard assessment tool for measuring the degree of rotational deformity. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lower Limb Deformity, Anterior Knee Pain Syndrome, Patellofemoral Pain
- What is being tested?
- Gait analysis
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Apr 2023to 30 Apr 2025
- Phase
- Observational
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Study population will include patients over 16 years of age who have previously had assessment of their gait and who have been diagnosed with suspected rotational deformity and patellofemoral pain/anterior knee pain. All genders will be accepted.
Who may be able to join
- All patients who have previously undergone gait analysis for assessment of patellofemoral pain and or instability
- Have a rotational CT scan available for assessment of femoral and tibial torsion
- Signed research consent form
Who cannot join
- No available CT scan available
- No gait analysis data available
- No signed gait research consent form
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Robert Jones and Agnes Hunt Orthopaedic Hospital
Oswestry
About this study
Official title: Is Gait Analysis for Proposed Rotational Deformities an Appropriate Use of Resources
Rotational deformities, such as femoral (thigh bone) and tibial (leg bone) torsion, are established causes of patellofemoral (kneecap joint) pain and instability. Currently, computerized tomography (CT) remains the gold standard assessment tool for measuring the degree of rotational deformity. However, there is disagreement as to the thresholds for surgical correction as it is suggested that some individuals compensate for the deformity better than others. Gait (walking) analysis provides important information of the biomechanical parameters undertaken in the knee joint during dynamic movement. In patients with rotational deformities, several variations from normal gait patterns have previously been described by several authors. Therefore, it is questioned whether these parameters can be correlated with the static features of CT scans, in individuals with rotational deformities. This study aims to determine whether gait analysis is a useful tool in the diagnosis and treatment pathway for rotational abnormalities in patellofemoral pain or instability. A secondary aim of this study will be to assess whether gait analysis can detect a rotational deformity in the lower limb and determine whether the changes seen are proportionate to the level of deformity.
Patients to be included in this retrospective study are, adult patients, with presumed rotational deformity of the lower limb, with anterior knee pain, who have been referred to the gait laboratory for assessment, and for CT rotational profiles. Only patients who have given consent to the gait laboratory for their information to be utilised in research will be included. Two researchers will record measures of rotational deformity from the CT images. The gait laboratory assessment includes measurements of biomechanical parameters based on joint movement through the gait cycle - these parameters will be assessed and compared with CT measures for correlation. All research will be conducted at the hospital where the gait laboratory assessment has been performed.
Read the detailed description
Patellofemoral pain (PFP) is one of the most common disorders in orthopaedic clinics (Rothermich, 2015). The knee pain is said to responsible for 25-40% of annual incidence, though a true prevalence is unknown (Witvrouw, 2014)(Lankhortst et al, 2012). Patient demographics range from young, active individuals to sedentary, elderly individuals (Witvrouw, 2014).
Primary care consultations to orthopaedic and musculoskeletal clinics, from knee pain alone, are reported to account for over 100,000 appointments annually (Smith et al., 2018). This costs the UK economy around £7.4million a year through employment absenteeism, alongside additional costs for non-operative and operative treatment procedures (Smith et al., 2018)(Swan et al., 2010).
Alongside age and activity, an important variable in understanding the epidemiology of PFP is the difference in the incidence and prevalence between genders. Many epidemiologic studies have shown that females have a two-fold higher incidence rate of the disorder than males (Rothermich, 2015).
The aetiology of PFP is evasive and multifactorial. Therefore, patients presenting with this syndrome pose a challenge for the diagnosis and long-term treatment of the pain. An important part of the diagnosis for the disorder is to rule out any other possible causes such as plica syndrome, neuromas or intra-articular pathology (Rothermich, 2015). Combinations of malalignment of the lower extremities, imbalance in muscles of the hips and knee joints, and over use, are the main factors which present most often and are considered causative to the disorder (Rothermich, 2015). One main contributors to PFP is that of lower limb structural factors, such as femoral ante/retro version and tibial torsion (Snow, 2021). These factors are thought to significantly effect gait and muscular function, which results in overloading of the joint and disturbed patellofemoral mechanics (Snow, 2021).
Currently, computerised tomography (CT) is the gold standard tool used to quantify rotational deformity on the lower limb (Snow, 2021). However, CT is a static imaging modality and does not capture the 'real life' dynamic kinetics that occur through movement (Saevarsson et al., 2013). Gait analysis provides important quantitative information of the biomechanical parameters undertaken in the knee joint during dynamic movement. In patients with rotational deformities, these parameters are either heightened or decreased on activity (Arazpour et al., 2016). Therefore, it is questioned as to whether gait analysis can detect a rotational deformity in the lower limb and determine whether the changes seen are proportionate to the level of deformity. Consequently, questioning as to whether gait analysis is an appropriate tool for diagnostic and treatment pathways for PFP.
- Conditions
- Lower Limb Deformity, Anterior Knee Pain Syndrome, Patellofemoral Pain, Rotation; Deformity
- Being tested
- Gait analysis
- Keywords
- Rotational Deformity, Gait Analysis, CT, Patellofemoral Pain
- Medical subject headings
- Patellofemoral Pain Syndrome, Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait analysisDiagnostic test
Also called CT
Analysis of gait profile and measures by gait laboratory on patients with suspected lower limb rotational deformities and anterior knee pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Is gait analysis a useful tool to determine rotational deformity?
The study aims to determine gait analysis is a useful tool in the diagnosis and treatment pathway for rotational abnormalities in patellofemoral pain or instability.
Measured: 3 months
Secondary outcomes (1)
Can gait analysis predict the same rotational deformity as CT
To assess whether gait analysis can detect a rotational deformity in the lower limb and determine whether the changes seen are proportionate to the level of deformity.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2022
- Study start21 Apr 2023
- Primary completion21 Apr 2023
- Study completion30 Apr 2025
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 Lower Limb DeformityStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Martyn Snow, Principal investigator, The Robert Jones and Agnes Hunt Orthopaedic Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05576064
- Sponsor's protocol ID
- RL1 860
- Status last verified
- May 2025
- First submitted
- 7 Oct 2022
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Arazpour M, Bahramian F, Abutorabi A, Nourbakhsh ST, Alidousti A, Aslani H. The Effect of Patellofemoral Pain Syndrome on Gait Parameters: A Literature Review. Arch Bone Jt Surg. 2016 Oct;4(4):298-306.
PubMed 27847840Lankhorst NE, Bierma-Zeinstra SM, van Middelkoop M. Factors associated with patellofemoral pain syndrome: a systematic review. Br J Sports Med. 2013 Mar;47(4):193-206. doi: 10.1136/bjsports-2011-090369. Epub 2012 Jul 19.
PubMed 22815424Rothermich MA, Glaviano NR, Li J, Hart JM. Patellofemoral pain: epidemiology, pathophysiology, and treatment options. Clin Sports Med. 2015 Apr;34(2):313-27. doi: 10.1016/j.csm.2014.12.011. Epub 2015 Jan 27.
PubMed 25818716Saevarsson SK, Romeo CI, Anglin C. Are static and dynamic kinematics comparable after total knee arthroplasty? J Biomech. 2013 Apr 5;46(6):1169-75. doi: 10.1016/j.jbiomech.2013.01.002. Epub 2013 Feb 8.
PubMed 23394715Smith BE, Selfe J, Thacker D, Hendrick P, Bateman M, Moffatt F, Rathleff MS, Smith TO, Logan P. Incidence and prevalence of patellofemoral pain: A systematic review and meta-analysis. PLoS One. 2018 Jan 11;13(1):e0190892. doi: 10.1371/journal.pone.0190892. eCollection 2018.
PubMed 29324820Snow M. Tibial Torsion and Patellofemoral Pain and Instability in the Adult Population: Current Concept Review. Curr Rev Musculoskelet Med. 2021 Feb;14(1):67-75. doi: 10.1007/s12178-020-09688-y. Epub 2021 Jan 8.
PubMed 33420589Tan SS, van Linschoten RL, van Middelkoop M, Koes BW, Bierma-Zeinstra SM, Koopmanschap MA. Cost-utility of exercise therapy in adolescents and young adults suffering from the patellofemoral pain syndrome. Scand J Med Sci Sports. 2010 Aug;20(4):568-79. doi: 10.1111/j.1600-0838.2009.00980.x. Epub 2009 Aug 23.
PubMed 19706002Witvrouw E, Callaghan MJ, Stefanik JJ, Noehren B, Bazett-Jones DM, Willson JD, Earl-Boehm JE, Davis IS, Powers CM, McConnell J, Crossley KM. Patellofemoral pain: consensus statement from the 3rd International Patellofemoral Pain Research Retreat held in Vancouver, September 2013. Br J Sports Med. 2014 Mar;48(6):411-4. doi: 10.1136/bjsports-2014-093450. No abstract available.
PubMed 24569145
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Gait Analysis for Proposed Rotational Deformities an Appropriate Use of Resources
- ClinicalTrials.gov ID
- NCT05576064
- Acronym / sponsor ID
- RL1 860
- Conditions
- Lower Limb Deformity, Anterior Knee Pain Syndrome, Patellofemoral Pain, Rotation; Deformity
- Keywords
- Rotational Deformity, Gait Analysis, CT, Patellofemoral Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Robert Jones and Agnes Hunt Orthopaedic and District NHS TrustOther government
- Study start
- 21 Apr 2023 (actual)
- Primary completion
- 21 Apr 2023 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 12 Oct 2022 (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.
Rotational deformities, such as femoral (thigh bone) and tibial (leg bone) torsion, are established causes of patellofemoral (kneecap joint) pain and instability. Currently, computerized tomography (CT) remains the gold standard assessment tool for measuring the degree of rotational deformity. However, there is disagreement as to the thresholds for surgical correction as it is suggested that some individuals compensate for the deformity better than others. Gait (walking) analysis provides important information of the biomechanical parameters undertaken in the knee joint during dynamic movement. In patients with rotational deformities, several variations from normal gait patterns have previously been described by several authors. Therefore, it is questioned whether these parameters can be correlated with the static features of CT scans, in individuals with rotational deformities. This study aims to determine whether gait analysis is a useful tool in the diagnosis and treatment pathway for rotational abnormalities in patellofemoral pain or instability. A secondary aim of this study will be to assess whether gait analysis can detect a rotational deformity in the lower limb and determine whether the changes seen are proportionate to the level of deformity.
Patients to be included in this retrospective study are, adult patients, with presumed rotational deformity of the lower limb, with anterior knee pain, who have been referred to the gait laboratory for assessment, and for CT rotational profiles. Only patients who have given consent to the gait laboratory for their information to be utilised in research will be included. Two researchers will record measures of rotational deformity from the CT images. The gait laboratory assessment includes measurements of biomechanical parameters based on joint movement through the gait cycle - these parameters will be assessed and compared with CT measures for correlation. All research will be conducted at the hospital where the gait laboratory assessment has been performed.
Detailed description
Patellofemoral pain (PFP) is one of the most common disorders in orthopaedic clinics (Rothermich, 2015). The knee pain is said to responsible for 25-40% of annual incidence, though a true prevalence is unknown (Witvrouw, 2014)(Lankhortst et al, 2012). Patient demographics range from young, active individuals to sedentary, elderly individuals (Witvrouw, 2014).
Primary care consultations to orthopaedic and musculoskeletal clinics, from knee pain alone, are reported to account for over 100,000 appointments annually (Smith et al., 2018). This costs the UK economy around £7.4million a year through employment absenteeism, alongside additional costs for non-operative and operative treatment procedures (Smith et al., 2018)(Swan et al., 2010).
Alongside age and activity, an important variable in understanding the epidemiology of PFP is the difference in the incidence and prevalence between genders. Many epidemiologic studies have shown that females have a two-fold higher incidence rate of the disorder than males (Rothermich, 2015).
The aetiology of PFP is evasive and multifactorial. Therefore, patients presenting with this syndrome pose a challenge for the diagnosis and long-term treatment of the pain. An important part of the diagnosis for the disorder is to rule out any other possible causes such as plica syndrome, neuromas or intra-articular pathology (Rothermich, 2015). Combinations of malalignment of the lower extremities, imbalance in muscles of the hips and knee joints, and over use, are the main factors which present most often and are considered causative to the disorder (Rothermich, 2015). One main contributors to PFP is that of lower limb structural factors, such as femoral ante/retro version and tibial torsion (Snow, 2021). These factors are thought to significantly effect gait and muscular function, which results in overloading of the joint and disturbed patellofemoral mechanics (Snow, 2021).
Currently, computerised tomography (CT) is the gold standard tool used to quantify rotational deformity on the lower limb (Snow, 2021). However, CT is a static imaging modality and does not capture the 'real life' dynamic kinetics that occur through movement (Saevarsson et al., 2013). Gait analysis provides important quantitative information of the biomechanical parameters undertaken in the knee joint during dynamic movement. In patients with rotational deformities, these parameters are either heightened or decreased on activity (Arazpour et al., 2016). Therefore, it is questioned as to whether gait analysis can detect a rotational deformity in the lower limb and determine whether the changes seen are proportionate to the level of deformity. Consequently, questioning as to whether gait analysis is an appropriate tool for diagnostic and treatment pathways for PFP.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Study population will include patients over 16 years of age who have previously had assessment of their gait and who have been diagnosed with suspected rotational deformity and patellofemoral pain/anterior knee pain. All genders will be accepted.
Key inclusion criteria (3 listed)
- All patients who have previously undergone gait analysis for assessment of patellofemoral pain and or instability
- Have a rotational CT scan available for assessment of femoral and tibial torsion
- Signed research consent form
Key exclusion criteria (3 listed)
- No available CT scan available
- No gait analysis data available
- No signed gait research consent form
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 analysisAlso: CTAnalysis of gait profile and measures by gait laboratory on patients with suspected lower limb rotational deformities and anterior knee pain | Diagnostic test | – |
Primary outcome
Is gait analysis a useful tool to determine rotational deformity?
Time frame: 3 months
The study aims to determine gait analysis is a useful tool in the diagnosis and treatment pathway for rotational abnormalities in patellofemoral pain or instability.
1 secondary outcome
Can gait analysis predict the same rotational deformity as CT
Time frame: 3 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 4 Jun 2025.
- Background: PubMed 27847840Arazpour M, Bahramian F, Abutorabi A, Nourbakhsh ST, Alidousti A, Aslani H. The Effect of Patellofemoral Pain Syndrome on Gait Parameters: A Literature Review. Arch Bone Jt Surg. 2016 Oct;4(4):298-306.
- Background: PubMed 22815424Lankhorst NE, Bierma-Zeinstra SM, van Middelkoop M. Factors associated with patellofemoral pain syndrome: a systematic review. Br J Sports Med. 2013 Mar;47(4):193-206. doi: 10.1136/bjsports-2011-090369. Epub 2012 Jul 19.
- Background: PubMed 25818716Rothermich MA, Glaviano NR, Li J, Hart JM. Patellofemoral pain: epidemiology, pathophysiology, and treatment options. Clin Sports Med. 2015 Apr;34(2):313-27. doi: 10.1016/j.csm.2014.12.011. Epub 2015 Jan 27.
- Background: PubMed 23394715Saevarsson SK, Romeo CI, Anglin C. Are static and dynamic kinematics comparable after total knee arthroplasty? J Biomech. 2013 Apr 5;46(6):1169-75. doi: 10.1016/j.jbiomech.2013.01.002. Epub 2013 Feb 8.
- Background: PubMed 29324820Smith BE, Selfe J, Thacker D, Hendrick P, Bateman M, Moffatt F, Rathleff MS, Smith TO, Logan P. Incidence and prevalence of patellofemoral pain: A systematic review and meta-analysis. PLoS One. 2018 Jan 11;13(1):e0190892. doi: 10.1371/journal.pone.0190892. eCollection 2018.
- Background: PubMed 33420589Snow M. Tibial Torsion and Patellofemoral Pain and Instability in the Adult Population: Current Concept Review. Curr Rev Musculoskelet Med. 2021 Feb;14(1):67-75. doi: 10.1007/s12178-020-09688-y. Epub 2021 Jan 8.
- Background: PubMed 19706002Tan SS, van Linschoten RL, van Middelkoop M, Koes BW, Bierma-Zeinstra SM, Koopmanschap MA. Cost-utility of exercise therapy in adolescents and young adults suffering from the patellofemoral pain syndrome. Scand J Med Sci Sports. 2010 Aug;20(4):568-79. doi: 10.1111/j.1600-0838.2009.00980.x. Epub 2009 Aug 23.
- Background: PubMed 24569145Witvrouw E, Callaghan MJ, Stefanik JJ, Noehren B, Bazett-Jones DM, Willson JD, Earl-Boehm JE, Davis IS, Powers CM, McConnell J, Crossley KM. Patellofemoral pain: consensus statement from the 3rd International Patellofemoral Pain Research Retreat held in Vancouver, September 2013. Br J Sports Med. 2014 Mar;48(6):411-4. doi: 10.1136/bjsports-2014-093450. No abstract available.
- Individual participant dataSharing planned: Undecided
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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.
Martyn Snow principal investigator
The Robert Jones and Agnes Hunt Orthopaedic Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lower Limb Deformity and Anterior Knee Pain Syndrome, run by Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust at 1 site in United Kingdom.
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 3 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 4 Jun 2025. 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 United Kingdom. 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?
Is gait analysis a useful tool to determine rotational deformity? (time frame: 3 months). 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 NCT05576064, 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 4 Jun 2025.