ChondromalaciaNCT02606942
Prevalence of Chondromalacia Patella Among Adolescent Dancers - Correlation Between Symptoms and Sonography Findings
An observational study of Chondromalacia and Cartilage Diseases, run by Sheba Medical Center at 1 site in Israel.
Trial summary
Comparing the physical and sonographic findings of dancers with Chondromalacia patella to non-dancers athletes. Read more about this study
- Who is it for?
- Ages 14 to 16 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Chondromalacia, Cartilage Diseases
- What is being tested?
- Questionnaires, physical exam, US of the knee
- How many people
- 90 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2016to Dec 2017
- 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 14 to 16 years
- Women only
- Healthy volunteers accepted
- Child
Study population: young adolescent female athletes or dancers
Who may be able to join
- Min. 3 hours of classic ballet dancing per week
- At least 4 years of dancing practice
- Reported knee pain during the last 6 months
- 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
- 1. Main physical activity is other than dancing
Who cannot join
- 1. Injury other than knee joint
- Group B - Dancers without knee injury:
- 1. None
- Group C - Non-dancers athletes:
- 1. Reported no musculoskeletal injury during the last 6 months
Trial locations and contacts
1 site in 1 country.
Nili Steinberg, DR contact
Itzhak Siev-Ner contact
Israel1 site
Department of Orthopedic Rehabilitation, Sheba Medical Center
Ramat Gan, 5265601
About this study
Comparing the physical and sonographic findings of dancers with Chondromalacia patella to non-dancers athletes.
Read the detailed description
A cross sectional study in which comparing of dancers to non-dancers athletes will be carried. Specifically, chondromalacia patella will be studied and compared between dancers with and without knee injuries and non-dancers athletes.
Study will include detailed function and pain questionnaires, physical findings and sonographic study of the knee joint.
- Conditions
- Chondromalacia, Cartilage Diseases
- Being tested
- Questionnaires, physical exam, US of the knee
- Keywords
- chondromalacia patellae (CMP), patella
- Medical subject headings
- Cartilage Diseases, Chondromalacia Patellae, Patella Fracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaires, physical exam, US of the kneeOther
Function and pain questioners, physical findings and sonographic study of the knee joint
| Study group | Role | What they receive |
|---|---|---|
| Dancers with knee injury | A cohort of dancers with reported knee injury. Questionnaires, physical exam, US of the knee Receives: 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 Receives: 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 Receives: Other: Questionnaires, physical exam, US of the knee |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical evaluation
Knee range of motion, ligament stability, hypermobility, patella grinding and inhibition test
Measured: 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
Measured: 1 hour
Secondary outcomes (2)
Visual Analog Score for pain
VAS score for pain
Measured: 1 hour
Function questionnaire
Questionnaire regarding athletic/dancing activities
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2015 (estimated)
- Study startJan 2016
- Primary completionJul 2016 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for ChondromalaciaStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Collaborators
- Zinman College of Physical Education and Sports Sciences
- Responsible party
- Principal investigator, Dr. Itzhak Siev-Ner, Sheba Medical Center
- Investigators
- Itzhak Siev-Ner, MD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02606942
- Sponsor's protocol ID
- SHEBA-2079-15-SMC
- Status last verified
- Jan 2016
- First submitted
- 9 Nov 2015
- Last updated
- 22 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18074410Steinberg 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.
PubMed 21086212Tursz 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.
PubMed 3728781Hamilton 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.
PubMed 16556782Bennell 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.
PubMed 10522638Negus 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.
PubMed 15966542Hamilton 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.
PubMed 1636856Steinberg 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.
PubMed 22288886Coplan 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.
PubMed 12449258Hincapie 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.
PubMed 18760170Steinberg 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.
PubMed 22562733Witvrouw 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.
PubMed 11292044Brussaard C, Naudts P, De Schepper A. Ultrasonographic diagnosis of chondromalacia of the femoropatellar joint. J Belge Radiol. 1991;74(4):303-6.
PubMed 1797798
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Chondromalacia Patella Among Adolescent Dancers - Correlation Between Symptoms and Sonography Findings
- ClinicalTrials.gov ID
- NCT02606942
- Acronym / sponsor ID
- SHEBA-2079-15-SMC
- Conditions
- Chondromalacia, Cartilage Diseases
- Keywords
- chondromalacia patellae (CMP), patella
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Collaborators
- Zinman College of Physical Education and Sports Sciences
- Study start
- Jan 2016
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 17 Nov 2015 (estimated)
- 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.
Comparing the physical and sonographic findings of dancers with Chondromalacia patella to non-dancers athletes.
Detailed description
A cross sectional study in which comparing of dancers to non-dancers athletes will be carried. Specifically, chondromalacia patella will be studied and compared between dancers with and without knee injuries and non-dancers athletes.
Study will include detailed function and pain questionnaires, physical findings and sonographic study of the knee joint.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dancers with knee injury | – | Other: Questionnaires, physical exam, US of the kneeA cohort of dancers with reported knee injury. Questionnaires, physical exam, US of the knee |
| Dancers with no knee injury | – | Other: Questionnaires, physical exam, US of the kneeA cohort of dancers without reported knee injury. Questionnaires, physical exam, US of the knee |
| Non-dancers athletes | – | Other: Questionnaires, physical exam, US of the kneeA cohort of non-dancers athletes without knee injuries. Questionnaires, physical exam, US of the knee |
Who may qualify
- Ages
- 14 to 16 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- young adolescent female athletes or dancers
Key inclusion criteria (7 listed)
- Min. 3 hours of classic ballet dancing per week
- At least 4 years of dancing practice
- Reported knee pain during the last 6 months
- Min. 3 hours of classic ballet dancing per week
- At least 4 years of dancing practice
Key exclusion criteria (5 listed)
- 1. Injury other than knee joint
- 1. None
- 1. Reported no musculoskeletal injury during the last 6 months
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 |
|---|---|---|
| Questionnaires, physical exam, US of the kneeFunction and pain questioners, physical findings and sonographic study of the knee joint | Other | Dancers with knee injury, Dancers with no knee injury, Non-dancers athletes |
Primary outcome
Physical evaluation
Time frame: 1 hour
Knee range of motion, ligament stability, hypermobility, patella grinding and inhibition test
US - sonographic study of the knee evaluation patellar, tibial and trochlear
Time frame: 1 hour
a sonographic study of the knee evaluating patellar, tibial and trochlear cartilage
2 secondary outcomes
Visual Analog Score for pain
Time frame: 1 hour
Function questionnaire
Time frame: 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2016.
- Results publication: PubMed 18074410Ivkovic 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.
- Results publication: PubMed 21086212Steinberg 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.
- Results publication: PubMed 3728781Tursz 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.
- Results publication: PubMed 16556782Hamilton 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.
- Results publication: PubMed 10522638Bennell 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.
- Results publication: PubMed 15966542Negus 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.
- Results publication: PubMed 1636856Hamilton 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.
- Results publication: PubMed 22288886Steinberg 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.
- Results publication: PubMed 12449258Coplan 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.
- Results publication: PubMed 18760170Hincapie 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.
- Results publication: PubMed 22562733Steinberg 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.
- Results publication: PubMed 11292044Witvrouw 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.
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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.
Nili Steinberg, DR contact
Itzhak Siev-Ner contact
Itzhak Siev-Ner, MD principal investigator
Sheba Medical Center
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 Chondromalacia and Cartilage Diseases, run by Sheba Medical Center at 1 site in Israel.
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 7 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 22 Jan 2016. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nili Steinberg, DR (knopp@wincol.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical evaluation (time frame: 1 hour). The study lists 2 primary outcomes in all. 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 NCT02606942, which also lists 13 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 22 Jan 2016; AzTrials last refreshed its copy on 8 Nov 2026.