NCT05576064

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 7, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 12, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

April 21, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 21, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
Last Updated

June 4, 2025

Status Verified

May 1, 2025

Enrollment Period

Same day

First QC Date

October 7, 2022

Last Update Submit

May 29, 2025

Conditions

Keywords

Rotational DeformityGait AnalysisCTPatellofemoral Pain

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 months

Secondary Outcomes (1)

  • Can gait analysis predict the same rotational deformity as CT

    3 months

Interventions

Gait analysisDIAGNOSTIC_TEST

Analysis of gait profile and measures by gait laboratory on patients with suspected lower limb rotational deformities and anterior knee pain

Also known as: CT

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • No available CT scan available
  • No gait analysis data available
  • No signed gait research consent form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Robert Jones and Agnes Hunt Orthopaedic Hospital

Oswestry, United Kingdom

Location

Related Publications (8)

  • 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.

    PMID: 27847840BACKGROUND
  • Lankhorst 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.

    PMID: 22815424BACKGROUND
  • Rothermich 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.

    PMID: 25818716BACKGROUND
  • Saevarsson 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.

    PMID: 23394715BACKGROUND
  • Smith 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.

    PMID: 29324820BACKGROUND
  • Snow 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.

    PMID: 33420589BACKGROUND
  • Tan 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.

    PMID: 19706002BACKGROUND
  • Witvrouw 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.

    PMID: 24569145BACKGROUND

MeSH Terms

Conditions

Patellofemoral Pain SyndromeCongenital Abnormalities

Interventions

Gait Analysis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

GaitPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisPhysical Functional PerformancePhysical FitnessHealthPopulation Characteristics

Study Officials

  • Martyn Snow

    The Robert Jones and Agnes Hunt Orthopaedic Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2022

First Posted

October 12, 2022

Study Start

April 21, 2023

Primary Completion

April 21, 2023

Study Completion

April 30, 2025

Last Updated

June 4, 2025

Record last verified: 2025-05

Locations