The Unstable Kneecap - the Impact of Anatomy on Function

NCT02569931 | Completed DMC

• 2 other identifiers: 15.006815/SC/0512
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

The principal objective of the study is to find out which everyday activities make the kneecap unstable in people with patellofemoral instability. Analysing how a patient with an unstable kneecap walks will help us to determine if surgery is successful in these patients by seeing if better scores on patient questionnaires are found in patients following surgery and whether these patients also have a better pattern of walking. The investigators aim to use cameras and pressure pads to see how patients walk before and after surgery and see how this compares to patient scores on the questionnaires. If the investigators find that patients walk better after surgery they can justify that surgery is worthwhile for the patient and cost effective for the NHS.

Conditions

Patellar Dislocation

Outcome Measures

Primary Outcomes (1)

• Number of participants with abnormal gait who have patellar instability

  Graphical measurement of raw kinematic data to include joint moments at ankle, knee and hip comparing patients with patellar instability to normal controls

  Before surgery

Secondary Outcomes (6)

• Number of patients with normal gait 6 months after surgery to correct patellar instability

  6 months

• Number of patients with normal ground reaction force 6 months after surgery to correct patellar instability

  6 months

• Number of patients with a change in patellar tracking at the time of surgery to correct patellar instability

  during surgery

• Number of patients with a change in patellar pressure at the time of surgery to correct patellar instability

  during surgery

• Number of patients who have an abnormal EMG compared to normal controls

  before surgery

Study Arms (2)

study group

EXPERIMENTAL

36 participants recruited aged between 18 to 50 years of age Participants will be considered eligible for the study group if they have had two or more episodes of patellar dislocation or multiple episodes of subluxation with at least one of the following: i. Positive patellar apprehension test ii. Tenderness along the medial retinaculum iii. Abnormal patellar tracking or position. The study group will undergo gait analysis and electromyography before surgery and 6 months after surgery. During surgery the study group will undergo intra-operative tracking and pressure measurements.

Other: Gait analysis; Other: Electromyography; Procedure: Intra-operative tracking and pressure measurements

control group

OTHER

36 participants recruited aged between 18 to 50 years of age, matched for age and gender with the study group. Control participants should be healthy subjects with no history of knee injury or surgery. The control group will undergo gait analysis and electromyography.

Other: Gait analysis; Other: Electromyography

Interventions

Gait analysis OTHER

Participants will be asked to walk on an instrumented treadmill. The study group will undergo gait analysis before surgery and 6 months after surgery. The control group will undergo gait analysis at one visit only.

control group; study group

Electromyography OTHER

Participants in the study group will undergo electromyography before and 6 months after surgery. Participants in the control group will undergo electromyography at one visit only

Also known as: muscle recording

control group; study group

Intra-operative tracking and pressure measurements PROCEDURE

Participants in the study group will undergo intra-operative tracking and pressure measurements to see if corrective surgery to stabilise the patella improves tracking and pressure measurements

study group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patient subjects will be considered eligible for the study group if they have had two or more episodes of patellar dislocation or multiple episodes of subluxation with at least one of the following:
• Positive patellar apprehension test
• Tenderness along the medial retinaculum
• Abnormal patellar tracking or position
• Control participants should be healthy subjects with no history of knee injury or surgery
• All participants will need to have the capacity to give informed consent in English
• All participants must be able to use public transport or drive

You may not qualify if:

• Pregnancy
• Breast feeding
• Arthritis
• Participation in other studies

Sponsors & Collaborators

• St George's, University of London: lead
• Imperial College London: collaborator

Study Sites (2)

St George's Hospital

London, SW17 0QT, United Kingdom

Location

Imperial College London

London, W68RP, United Kingdom

Location

MeSH Terms

Conditions

Patellar Dislocation

Interventions

Gait Analysis; Neurofeedback

Condition Hierarchy (Ancestors)

Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Knee Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Gait; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Physical Functional Performance; Physical Fitness; Health; Population Characteristics; Biofeedback, Psychology; Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Study Officials

• Caroline Hing, FRCS

  St George's, University of London

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2015
• First Posted: October 7, 2015
• Study Start: December 1, 2015
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: April 29, 2024

Record last verified: 2020-03

Locations

GB (2)