Meniscus TearNCT05114694
Early Arthroscopic Partial Meniscectomy(APM)
A study testing early APM and delayed APM in people with Meniscus Tear, run by The First People's Hospital of Jingzhou at 1 site in China.
Trial summary
Arthroscopic partial meniscectomy(APM) surgery outcomes for Metabolic Syndrome(MetS) patients with degenerative meniscus tears(DMTs) was still not clear. The aim of the study was to investigate outcomes of early APM vs delayed APM for MetS patients with degenerate meniscus tears. Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Meniscus Tear
- What is being tested?
- early APM and delayed APM
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 15 Jan 2018to 7 Dec 2022
- Phase
- Interventional
- 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 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Must be age between 35 and 70 years old;
- Clinical diagnosis of metabolic syndrome;
- Clinical diagnosis of degnerate meniscus tears;
Who cannot join
- Must be able to have no acute knee injury such as car crash or acute sports injury;
- Must be able to have no knee surgeries history;
- Must be able to have no rheumatoid arthritis or serious knee osteoarthritis with deformity;
- Must be able to have no contraindications to MRI;
- Must be able to have no severe cardiopulmonary disease;
- Must be able to have no musculoskeletal or neuromuscular impairments ;
- Must be able to have good visual, hearing, or cognitive;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Jinzhou Medical University
Jinzhou, Liaoning, 121000
Yue Guo, Master, 13897830515, 373073766@qq.com
Ziming Zhao, Master, 18841609587, zhzm622@163.com
About this study
Official title: Consultant of Shenzhen People's Hospital
Arthroscopic partial meniscectomy(APM) surgery outcomes for Metabolic Syndrome(MetS) patients with degenerative meniscus tears(DMTs) was still not clear. The aim of the study was to investigate outcomes of early APM vs delayed APM for MetS patients with degenerate meniscus tears.
Read the detailed description
Degenerate meniscus tears(DMTs) were the most common knee disease in aged and obese people. The most common treatment for DMTs was arthroscopic partial meniscectomy(APM) surgery. However, the time window for performing APM surgery was unclear, especially in obese patients with Metabolic syndrome(MetS). Abdominal obesity, insulin resistance with or without glucose intolerance, dyslipidemia or elevated blood pressure are included in the principal components of MetS. Whether early APM within 3 to 6 months or delayed APM surgery within 6 to 12 months are benefical to MetS patients with DMTs. The knee function outcomes between early APM and delayed APM for MetS patients with DMTs were assessed and follow up to 12 months after surgery.
- Conditions
- Meniscus Tear
- Being tested
- early APM, delayed APM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
early APMProcedure or surgery
Also called Early arthroscopic partial meniscectomy
Early APM group were patients have knee syndrome within 3 to 6 months
delayed APMProcedure or surgery
Also called delayed arthroscopic partial meniscectomy
delayed APM group recruit participants who received delayed APM surgery within 6 to 12 months
| Study group | Role | What they receive |
|---|---|---|
| early APM | Experimental | Early APM group were patients have knee syndrome within 3 to 6 months Receives: Procedure: early APM |
| delayed APM | Placebo comparator | delayed APM group recruit participants who received delayed APM surgery within 6 to 12 months Receives: Procedure: delayed APM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee KOOS score
The KOOS was a self-administered outcome questionnaire has been validated in individuals undergoing APM surgery,with 0(extreme knee problem) to 100 points(the best possible score, no knee problems)
Measured: up to 12 month
IKDC score
The IKDC was a questionnaire that has high reliability and validity for middle to older patients with a meniscal tear,with 0(extreme knee problem) to 100 points(the best possible score, no knee problems)
Measured: up to 12 month
waist circumstance
midway between the lowest rib and the iliac crest, using an anthropometric tape
Measured: at baseline
SBP
systolic blood pressure
Measured: at baseline
DBP
diastolic blood pressure
Measured: at baseline
TC
serum total cholesterol (TC)
Measured: at baseline
TG
serum triglycerides (TG)
Measured: at baseline
LDL
serum low-density lipoprotein cholesterol (LDL-C)
Measured: at baseline
HDL
serum high-density lipoprotein cholesterol (HDL-C)
Measured: at baseline
FBG
serum fast blood glucose(FBG)
Measured: at baseline
BMI
BMI, calculated as weight in kilograms divided by height in meters squaredBMI in kg/m^2
Measured: at baseline
K-L grade
Kellgren-Lawrence (K/L) grade
Measured: at baseline
Secondary outcomes (5)
pain score
The KOOS subscales for pain,with 0(extreme knee problem) to 100 points(the best possible score, no knee problems)
Measured: up to 12 month
symptoms score
The KOOS subscales for symptoms,with 0(extreme knee problem) to 100 points(the best possible score, no knee problems)
Measured: up to 12 month
activities of daily living score
The KOOS subscales for activities of daily living,with 0(extreme knee problem) to 100 points(the best possible score, no knee problems)
Measured: up to 12 month
function in sport and recreation score
The KOOS subscales for function in sport and recreation,with 0(extreme knee problem) to 100 points(the best possible score, no knee problems)
Measured: up to 12 month
knee related quality of life score
The KOOS subscales for knee related quality of life,with 0(extreme knee problem) to 100 points(the best possible score, no knee problems)
Measured: up to 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2021
- Study start15 Jan 2018
- Primary completion5 Dec 2022 (estimated)
- Study completion7 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meniscus TearStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First People's Hospital of Jingzhou
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongyu Wang, The First People's Hospital of Jingzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05114694
- Sponsor's protocol ID
- APM TIME
- Status last verified
- Nov 2022
- First submitted
- 5 Nov 2021
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consultant of Shenzhen People's Hospital
- ClinicalTrials.gov ID
- NCT05114694
- Acronym / sponsor ID
- APM TIME
- Conditions
- Meniscus Tear
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- The First People's Hospital of JingzhouUniversity, hospital or other
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 5 Dec 2022 (estimated)
- Study completion
- 7 Dec 2022 (estimated)
- First posted
- 10 Nov 2021 (actual)
- 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.
Arthroscopic partial meniscectomy(APM) surgery outcomes for Metabolic Syndrome(MetS) patients with degenerative meniscus tears(DMTs) was still not clear. The aim of the study was to investigate outcomes of early APM vs delayed APM for MetS patients with degenerate meniscus tears.
Detailed description
Degenerate meniscus tears(DMTs) were the most common knee disease in aged and obese people. The most common treatment for DMTs was arthroscopic partial meniscectomy(APM) surgery. However, the time window for performing APM surgery was unclear, especially in obese patients with Metabolic syndrome(MetS). Abdominal obesity, insulin resistance with or without glucose intolerance, dyslipidemia or elevated blood pressure are included in the principal components of MetS. Whether early APM within 3 to 6 months or delayed APM surgery within 6 to 12 months are benefical to MetS patients with DMTs. The knee function outcomes between early APM and delayed APM for MetS patients with DMTs were assessed and follow up to 12 months after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| early APM | Experimental | Procedure: early APMEarly APM group were patients have knee syndrome within 3 to 6 months |
| delayed APM | Placebo comparator | Procedure: delayed APMdelayed APM group recruit participants who received delayed APM surgery within 6 to 12 months |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- • Must be age between 35 and 70 years old;
Key exclusion criteria (7 listed)
- Must be able to have no acute knee injury such as car crash or acute sports injury;
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 |
|---|---|---|
| early APMAlso: Early arthroscopic partial meniscectomyEarly APM group were patients have knee syndrome within 3 to 6 months | Procedure or surgery | early APM |
| delayed APMAlso: delayed arthroscopic partial meniscectomydelayed APM group recruit participants who received delayed APM surgery within 6 to 12 months | Procedure or surgery | delayed APM |
Primary outcome
Knee KOOS score
Time frame: up to 12 month
The KOOS was a self-administered outcome questionnaire has been validated in individuals undergoing APM surgery,with 0(extreme knee problem) to 100 points(the best possible score, no knee problems)
IKDC score
Time frame: up to 12 month
The IKDC was a questionnaire that has high reliability and validity for middle to older patients with a meniscal tear,with 0(extreme knee problem) to 100 points(the best possible score, no knee problems)
waist circumstance
Time frame: at baseline
midway between the lowest rib and the iliac crest, using an anthropometric tape
SBP
Time frame: at baseline
systolic blood pressure
DBP
Time frame: at baseline
diastolic blood pressure
TC
Time frame: at baseline
serum total cholesterol (TC)
TG
Time frame: at baseline
serum triglycerides (TG)
LDL
Time frame: at baseline
serum low-density lipoprotein cholesterol (LDL-C)
HDL
Time frame: at baseline
serum high-density lipoprotein cholesterol (HDL-C)
FBG
Time frame: at baseline
serum fast blood glucose(FBG)
BMI
Time frame: at baseline
BMI, calculated as weight in kilograms divided by height in meters squaredBMI in kg/m^2
K-L grade
Time frame: at baseline
Kellgren-Lawrence (K/L) grade
5 secondary outcomes
pain score
Time frame: up to 12 month
symptoms score
Time frame: up to 12 month
activities of daily living score
Time frame: up to 12 month
function in sport and recreation score
Time frame: up to 12 month
knee related quality of life score
Time frame: up to 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing early APM and delayed APM in people with Meniscus Tear, run by The First People's Hospital of Jingzhou at 1 site in China.
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 14 Nov 2022. 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 China. 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. Some participants in this study may receive a placebo. 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 Yue Guo, Master (13897830515, 373073766@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee KOOS score (time frame: up to 12 month). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 14 Nov 2022.