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The Unstable Kneecap - the Impact of Anatomy on Function (SPRING)

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ClinicalTrials.gov Identifier: NCT02569931
Recruitment Status : Recruiting
First Posted : October 7, 2015
Last Update Posted : January 17, 2019
Sponsor:
Collaborator:
Imperial College London
Information provided by (Responsible Party):
St George's, University of London

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.


Condition or disease Intervention/treatment Phase
Patellar Dislocation Other: Gait analysis Other: Electromyography Procedure: Intra-operative tracking and pressure measurements Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Surgery for Patellofemoral Instability, is There Normal Gait
Study Start Date : December 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Experimental: study group

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
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.

Other: Electromyography
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
Other Name: muscle recording

Procedure: Intra-operative tracking and pressure measurements
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

control group

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
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.

Other: Electromyography
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
Other Name: muscle recording




Primary Outcome Measures :
  1. Number of participants with abnormal gait who have patellar instability [ Time Frame: Before surgery ]
    Graphical measurement of raw kinematic data to include joint moments at ankle, knee and hip comparing patients with patellar instability to normal controls


Secondary Outcome Measures :
  1. Number of patients with normal gait 6 months after surgery to correct patellar instability [ Time Frame: 6 months ]
    Graphical measurement of raw kinematic data to include joint moments at ankle, knee and hip comparing patients after surgery to correct patellar instability to normal controls

  2. Number of patients with normal ground reaction force 6 months after surgery to correct patellar instability [ Time Frame: 6 months ]
    Measurement of ground reaction force of patients after surgery to correct patellar instability compared to normal controls

  3. Number of patients with a change in patellar tracking at the time of surgery to correct patellar instability [ Time Frame: during surgery ]
    Graphical presentation of patellar movement in three dimensions measured intra-operatively during corrective surgery

  4. Number of patients with a change in patellar pressure at the time of surgery to correct patellar instability [ Time Frame: during surgery ]
    Graphical presentation of patellar pressure in three dimensions measured intra-operatively during corrective surgery

  5. Number of patients who have an abnormal EMG compared to normal controls [ Time Frame: before surgery ]
    Electromyographic (EMG) output in graphical form comparing patients with patellar instability to normal controls

  6. Number of patients with a change in EMG 6 months after surgery to correct patellar instability [ Time Frame: 6 months ]
    Electromyographic (EMG) output in graphical form comparing patients before and after surgery



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02569931


Contacts
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Contact: Arash Aframian, MB BS +447966052404 a.aframian@nhs.net
Contact: Caroline Hing, FRCS +4487255688 caroline.hing@stgeorges.nhs.uk

Locations
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United Kingdom
St George's Hospital Recruiting
London, United Kingdom, SW17 0QT
Contact: Caroline Hing, MB BS    00442087255688    caroline.hing@stgeorges.nhs.uk   
Imperial College London Recruiting
London, United Kingdom, W68RP
Contact: Arash Aframian, MB BS    00442088461687    arash.aframian@gmail.com   
Sponsors and Collaborators
St George's, University of London
Imperial College London
Investigators
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Study Chair: Caroline Hing, FRCS St George's, University of London
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Responsible Party: St George's, University of London
ClinicalTrials.gov Identifier: NCT02569931    
Other Study ID Numbers: 15.0068
15/SC/0512 ( Other Identifier: REC/IRB reference )
First Posted: October 7, 2015    Key Record Dates
Last Update Posted: January 17, 2019
Last Verified: January 2019
Additional relevant MeSH terms:
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Patellar Dislocation
Joint Dislocations
Joint Diseases
Musculoskeletal Diseases
Wounds and Injuries
Knee Injuries
Leg Injuries