NCT02606942

Brief Summary

Comparing the physical and sonographic findings of dancers with Chondromalacia patella to non-dancers athletes.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
unknown

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

November 9, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 17, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

January 22, 2016

Status Verified

January 1, 2016

Enrollment Period

6 months

First QC Date

November 9, 2015

Last Update Submit

January 21, 2016

Conditions

Keywords

chondromalacia patellae (CMP)patella

Outcome Measures

Primary Outcomes (2)

  • Physical evaluation

    Knee range of motion, ligament stability, hypermobility, patella grinding and inhibition test

    1 hour

  • US - sonographic study of the knee evaluation patellar, tibial and trochlear

    a sonographic study of the knee evaluating patellar, tibial and trochlear cartilage

    1 hour

Secondary Outcomes (2)

  • Visual Analog Score for pain

    1 hour

  • Function questionnaire

    1 hour

Study Arms (3)

Dancers with knee injury

A cohort of dancers with reported knee injury. Questionnaires, physical exam, US of the knee

Other: Questionnaires, physical exam, US of the knee

Dancers with no knee injury

A cohort of dancers without reported knee injury. Questionnaires, physical exam, US of the knee

Other: Questionnaires, physical exam, US of the knee

Non-dancers athletes

A cohort of non-dancers athletes without knee injuries. Questionnaires, physical exam, US of the knee

Other: Questionnaires, physical exam, US of the knee

Interventions

Function and pain questioners, physical findings and sonographic study of the knee joint

Dancers with knee injuryDancers with no knee injuryNon-dancers athletes

Eligibility Criteria

Age14 Years - 16 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

young adolescent female athletes or dancers

You may qualify if:

  • Min. 3 hours of classic ballet dancing per week
  • At least 4 years of dancing practice
  • Reported knee pain during the last 6 months

You may not qualify if:

  • \. Injury other than knee joint
  • Group B - Dancers without knee injury:
  • Min. 3 hours of classic ballet dancing per week
  • At least 4 years of dancing practice
  • Reported no musculoskeletal injury during the last 6 months
  • \. None
  • Group C - Non-dancers athletes:
  • \. Main physical activity is other than dancing
  • \. Reported no musculoskeletal injury during the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Orthopedic Rehabilitation, Sheba Medical Center

Ramat Gan, 5265601, Israel

Location

Related Publications (13)

  • Ivkovic A, Franic M, Bojanic I, Pecina M. Overuse injuries in female athletes. Croat Med J. 2007 Dec;48(6):767-78. doi: 10.3325/cmj.2007.6.767.

  • Steinberg N, Siev-Ner I, Peleg S, Dar G, Masharawi Y, Zeev A, Hershkovitz I. Injury patterns in young, non-professional dancers. J Sports Sci. 2011 Jan;29(1):47-54. doi: 10.1080/02640414.2010.521167.

  • Tursz A, Crost M. Sports-related injuries in children. A study of their characteristics, frequency, and severity, with comparison to other types of accidental injuries. Am J Sports Med. 1986 Jul-Aug;14(4):294-9. doi: 10.1177/036354658601400409.

  • Hamilton D, Aronsen P, Loken JH, Berg IM, Skotheim R, Hopper D, Clarke A, Briffa NK. Dance training intensity at 11-14 years is associated with femoral torsion in classical ballet dancers. Br J Sports Med. 2006 Apr;40(4):299-303; discussion 303. doi: 10.1136/bjsm.2005.020941.

  • Bennell K, Khan KM, Matthews B, De Gruyter M, Cook E, Holzer K, Wark JD. Hip and ankle range of motion and hip muscle strength in young female ballet dancers and controls. Br J Sports Med. 1999 Oct;33(5):340-6. doi: 10.1136/bjsm.33.5.340.

  • Negus V, Hopper D, Briffa NK. Associations between turnout and lower extremity injuries in classical ballet dancers. J Orthop Sports Phys Ther. 2005 May;35(5):307-18. doi: 10.2519/jospt.2005.35.5.307.

  • Hamilton WG, Hamilton LH, Marshall P, Molnar M. A profile of the musculoskeletal characteristics of elite professional ballet dancers. Am J Sports Med. 1992 May-Jun;20(3):267-73. doi: 10.1177/036354659202000306.

  • Steinberg N, Siev-Ner I, Peleg S, Dar G, Masharawi Y, Zeev A, Hershkovitz I. Extrinsic and intrinsic risk factors associated with injuries in young dancers aged 8-16 years. J Sports Sci. 2012;30(5):485-95. doi: 10.1080/02640414.2011.647705. Epub 2012 Jan 30.

  • Coplan JA. Ballet dancer's turnout and its relationship to self-reported injury. J Orthop Sports Phys Ther. 2002 Nov;32(11):579-84. doi: 10.2519/jospt.2002.32.11.579.

  • Hincapie CA, Morton EJ, Cassidy JD. Musculoskeletal injuries and pain in dancers: a systematic review. Arch Phys Med Rehabil. 2008 Sep;89(9):1819-29. doi: 10.1016/j.apmr.2008.02.020.

  • Steinberg N, Siev-Ner I, Peleg S, Dar G, Masharawi Y, Zeev A, Hershkovitz I. Joint range of motion and patellofemoral pain in dancers. Int J Sports Med. 2012 Jul;33(7):561-6. doi: 10.1055/s-0031-1301330. Epub 2012 May 4.

  • Witvrouw E, Bellemans J, Lysens R, Danneels L, Cambier D. Intrinsic risk factors for the development of patellar tendinitis in an athletic population. A two-year prospective study. Am J Sports Med. 2001 Mar-Apr;29(2):190-5. doi: 10.1177/03635465010290021201.

  • Brussaard C, Naudts P, De Schepper A. Ultrasonographic diagnosis of chondromalacia of the femoropatellar joint. J Belge Radiol. 1991;74(4):303-6.

MeSH Terms

Conditions

Cartilage DiseasesChondromalacia PatellaePatella Fracture

Interventions

Surveys and QuestionnairesRestraint, Physical

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesKnee FracturesFractures, BoneWounds and Injuries

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthBehavior ControlTherapeuticsImmobilization

Study Officials

  • Itzhak Siev-Ner, MD

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nili Steinberg, DR

CONTACT

Itzhak Siev-Ner

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the Department of Orthopedic Rehabilitaion

Study Record Dates

First Submitted

November 9, 2015

First Posted

November 17, 2015

Study Start

January 1, 2016

Primary Completion

July 1, 2016

Study Completion

December 1, 2017

Last Updated

January 22, 2016

Record last verified: 2016-01

Locations