Meniscus LesionNCT05655442
Arthroscopic Partial Meniscectomy Time Window
A study testing early APM and delayed APM in people with Meniscus Lesion, run by Shenzhen People's Hospital.
Trial summary
The purpose was to assess knee function outcomes between early arthroscopic partial meniscectomy(APM) and delayed APM for patients with degenerative meniscus lesions(DMLs) Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Meniscus Lesion
- What is being tested?
- early APM and delayed APM
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 12 Jan 2020to 28 Aug 2023
- 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
- • Clinical diagnosis of degenerative meniscus lesions based on knee MRI
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;
About this study
Official title: Effect of Early vs Delayed Arthroscopic Partial Meniscectomy on the Knee Function of Patients With Degenerative Meniscus Lesions
The purpose was to assess knee function outcomes between early arthroscopic partial meniscectomy(APM) and delayed APM for patients with degenerative meniscus lesions(DMLs)
Read the detailed description
Whether early APM surgery or delayed APM surgery will more benefit for patients with DMLs. The study was to determine the early APM vs delayed APM effect on knee function outcomes for patients with DMLs for 1 year follow-up.
- Conditions
- Meniscus Lesion
- 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
early APM within 3 and 6 month knee pain symptoms
delayed APMProcedure or surgery
delayed APM within 6 and 12 month knee pain symptoms
| Study group | Role | What they receive |
|---|---|---|
| early APM | Experimental | early APM within 3 and 6 month knee pain symptoms Receives: Procedure: early APM |
| delayed APM | Active comparator | delayed APM within 6 and 12 month knee pain symptoms Receives: Procedure: delayed APM |
What is being measured
The primary outcome is the main question the study is designed to answer.
the Knee Injury and Osteoarthritis Outcome Score (KOOS) change
The Knee injury and Osteoarthritis Outcome Score (KOOS) holds five subscales including: Pain (9 items); other Symptoms (7 items); Activities of Daily Living (ADL, 17 items); Sport and Recreation function (Sport/Rec, 5 items); and knee-related Quality of Life (QoL, 4 items). Each subscale is scored separately from zero (extreme knee problems) to 100 (no knee problems)
Measured: change from baseline up to 12 months
International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC Score) change
The International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC) score questionnaire contains 18 items (7 items for symptoms, 1 item for sport activity, 9 items for daily activities, and 1 item for current knee function.) The total score is transformed to a value on a scale of 0 to 100, with 100 representing the highest knee function and 0 is the worst.
Measured: change from baseline up to 12 months
Kellgren-Lawrence (K/L) grade change
Kellgren-Lawrence (K/L) grade via X ray
Measured: change from baseline up to 12 months
the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) change
Te WOMAC is a self assessed health status scale for patients consisting of 24 items in three subscales of pain (5 items), stiffness (2 items), and physical function (17 items). All items are scored from 0 (asymptomatic) to 4 (very severe), and the total score ranges from 0 to 96, with higher scores indicating more severe symptoms
Measured: change from baseline up to 12 months
Secondary outcomes (5)
KOOS pain score change
The minimum is 0 points, the maximum is 4 points, from extreme knee problems to no knee problems. After the score of each part is calculated separately, it is converted into a percentage score by the conversion formula.
Measured: change from baseline up to 12 months
KOOS symptoms score change
The minimum is 0 points, the maximum is 4 points, from extreme knee problems to no knee problems. After the score of each part is calculated separately, it is converted into a percentage score by the conversion formula.
Measured: change from baseline up to 12 months
KOOS activities of daily living score change
The minimum is 0 points, the maximum is 4 points, from extreme knee problems to no knee problems. After the score of each part is calculated separately, it is converted into a percentage score by the conversion formula.
Measured: change from baseline up to 12 months
KOOS function in sport and recreation score change
The minimum is 0 points, the maximum is 4 points, from extreme knee problems to no knee problems. After the score of each part is calculated separately, it is converted into a percentage score by the conversion formula.
Measured: change from baseline up to 12 months
KOOS knee related quality of life score change
The minimum is 0 points, the maximum is 4 points, from extreme knee problems to no knee problems. After the score of each part is calculated separately, it is converted into a percentage score by the conversion formula.
Measured: change from baseline up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2022
- Study start12 Jan 2020
- Primary completion5 Jul 2023 (estimated)
- Study completion28 Aug 2023 (estimated)
Why it stopped: No enough participants recruited
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meniscus LesionStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shenzhen People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hongyu Wang, Doctor, Principal investigator, Shenzhen People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05655442
- Sponsor's protocol ID
- SZlesions
- Status last verified
- Mar 2023
- First submitted
- 7 Dec 2022
- Last updated
- 14 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Early vs Delayed Arthroscopic Partial Meniscectomy on the Knee Function of Patients With Degenerative Meniscus Lesions
- ClinicalTrials.gov ID
- NCT05655442
- Acronym / sponsor ID
- SZlesions
- Conditions
- Meniscus Lesion
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No enough participants recruited
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Shenzhen People's HospitalUniversity, hospital or other
- Study start
- 12 Jan 2020 (actual)
- Primary completion
- 5 Jul 2023 (estimated)
- Study completion
- 28 Aug 2023 (estimated)
- First posted
- 19 Dec 2022 (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.
The purpose was to assess knee function outcomes between early arthroscopic partial meniscectomy(APM) and delayed APM for patients with degenerative meniscus lesions(DMLs)
Detailed description
Whether early APM surgery or delayed APM surgery will more benefit for patients with DMLs. The study was to determine the early APM vs delayed APM effect on knee function outcomes for patients with DMLs for 1 year follow-up.
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 within 3 and 6 month knee pain symptoms |
| delayed APM | Active comparator | Procedure: delayed APMdelayed APM within 6 and 12 month knee pain symptoms |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- • Clinical diagnosis of degenerative meniscus lesions based on knee MRI
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 APMearly APM within 3 and 6 month knee pain symptoms | Procedure or surgery | early APM |
| delayed APMdelayed APM within 6 and 12 month knee pain symptoms | Procedure or surgery | delayed APM |
Primary outcome
the Knee Injury and Osteoarthritis Outcome Score (KOOS) change
Time frame: change from baseline up to 12 months
The Knee injury and Osteoarthritis Outcome Score (KOOS) holds five subscales including: Pain (9 items); other Symptoms (7 items); Activities of Daily Living (ADL, 17 items); Sport and Recreation function (Sport/Rec, 5 items); and knee-related Quality of Life (QoL, 4 items). Each subscale is scored separately from zero (extreme knee problems) to 100 (no knee problems)
International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC Score) change
Time frame: change from baseline up to 12 months
The International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC) score questionnaire contains 18 items (7 items for symptoms, 1 item for sport activity, 9 items for daily activities, and 1 item for current knee function.) The total score is transformed to a value on a scale of 0 to 100, with 100 representing the highest knee function and 0 is the worst.
Kellgren-Lawrence (K/L) grade change
Time frame: change from baseline up to 12 months
Kellgren-Lawrence (K/L) grade via X ray
the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) change
Time frame: change from baseline up to 12 months
Te WOMAC is a self assessed health status scale for patients consisting of 24 items in three subscales of pain (5 items), stiffness (2 items), and physical function (17 items). All items are scored from 0 (asymptomatic) to 4 (very severe), and the total score ranges from 0 to 96, with higher scores indicating more severe symptoms
5 secondary outcomes
KOOS pain score change
Time frame: change from baseline up to 12 months
KOOS symptoms score change
Time frame: change from baseline up to 12 months
KOOS activities of daily living score change
Time frame: change from baseline up to 12 months
KOOS function in sport and recreation score change
Time frame: change from baseline up to 12 months
KOOS knee related quality of life score change
Time frame: change from baseline up to 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
- Individual participant dataSharing planned: No
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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.
Hongyu Wang, Doctor principal investigator
Shenzhen People's Hospital
Questions about this trial
What is this clinical trial studying?
A study testing early APM and delayed APM in people with Meniscus Lesion, run by Shenzhen People's Hospital.
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 1 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: withdrawn, as of the sponsor's last update on 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the Knee Injury and Osteoarthritis Outcome Score (KOOS) change (time frame: change from baseline up to 12 months). The study lists 4 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 Mar 2023.