Torn MenisciNCT00256971
Balance in Patients After Surgery for Torn Meniscus
An observational study of Torn Menisci, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
The important role of the menisci in knee function and in preserving knee health has been shown in several studies. Additionally to principal functions of load transmission and shock absorption, meniscus contributes to knee joint proprioception and probably also to joint stability.Study about affect of meniscus injury… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Torn Menisci
- What is being tested?
- meniscectomy
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2005to Jan 2008
- 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 18 to 40 years
- All sexes
- Adult
Who may be able to join
- Participants have to be healthy people
- 18-40 years old
- After a traumatic event of only one knee
Who cannot join
- Previous knee surgery
- OA per arthroscopy
- Neurological problem
- Any other orthopedic problem of lower limbs
- Systemic arthritic condition (RA, SLE etc.)
- Severe cognitive problem with restricted consent
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Hadassah Medical Organization,
Jerusalem
Arik, Tzukert, DMD, 00 972 2 6776095, arik@hadassah.org.il
Hadas Lemberg,, PhD, 00 972 2 6777572, : lhadas@hadassah.org.il
About this study
Official title: Functioning Balance in Patients After Surgery for Torn Meniscus: Meniscectomy vs Meniscal Repair; A Prospective Study
The important role of the menisci in knee function and in preserving knee health has been shown in several studies. Additionally to principal functions of load transmission and shock absorption, meniscus contributes to knee joint proprioception and probably also to joint stability.Study about affect of meniscus injury on balance posture has not previously been published.Surgical practice is increasingly aimed at minimal resection of injured tissue, preserving a stable meniscal remnant with as much function as possible.The purpose of this study is to determine whether menisci surgery have any effects on relatively new postural control measures, in correlation with functional balance assessment. The second purpose is to establish the affect of different types of menisci surgery on balance impairment (meniscectomy vs tear repair), in correlation with a long-term outcome.
- Conditions
- Torn Menisci
- Being tested
- meniscectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
meniscectomyProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2005 (estimated)
- Study startNov 2005
- Study completionJan 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Torn MenisciStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe 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
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- isabella schwartz, Principal investigator, Hadassah Medical Organization IRB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00256971
- Sponsor's protocol ID
- MEN-BM-HMO-CTIL
- Status last verified
- Nov 2005
- First submitted
- 20 Nov 2005
- Last updated
- 13 May 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functioning Balance in Patients After Surgery for Torn Meniscus: Meniscectomy vs Meniscal Repair; A Prospective Study
- ClinicalTrials.gov ID
- NCT00256971
- Acronym / sponsor ID
- MEN-BM-HMO-CTIL
- Conditions
- Torn Menisci
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Nov 2005
- Study completion
- Jan 2008 (estimated)
- First posted
- 22 Nov 2005 (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.
The important role of the menisci in knee function and in preserving knee health has been shown in several studies. Additionally to principal functions of load transmission and shock absorption, meniscus contributes to knee joint proprioception and probably also to joint stability.Study about affect of meniscus injury on balance posture has not previously been published.Surgical practice is increasingly aimed at minimal resection of injured tissue, preserving a stable meniscal remnant with as much function as possible.The purpose of this study is to determine whether menisci surgery have any effects on relatively new postural control measures, in correlation with functional balance assessment. The second purpose is to establish the affect of different types of menisci surgery on balance impairment (meniscectomy vs tear repair), in correlation with a long-term outcome.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Participants have to be healthy people
- 18-40 years old
- After a traumatic event of only one knee
Key exclusion criteria (7 listed)
- Previous knee surgery
- OA per arthroscopy
- Neurological problem
- Any other orthopedic problem of lower limbs
- Systemic arthritic condition (RA, SLE etc.)
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 |
|---|---|---|
| meniscectomy | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2008.
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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.
isabella schwartz principal investigator
Hadassah Medical Organization IRB
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 Torn Menisci, run by Hadassah Medical Organization 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 3 inclusion and 7 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 13 May 2008. 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 Isabella Schwartz, MD (972-25844474, isabellas@hadassah.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
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 13 May 2008.