Knee Medial Meniscus TearsNCT05655429
Physical Therapy vs Arthroscopic Partial Meniscectomy
A study testing physical therapy and arthroscopic partial meniscectomy in people with Knee Medial Meniscus Tears, run by Shenzhen People's Hospital at 1 site in China.
Trial summary
The purpose was to assess knee function outcomes between physical therapy and arthroscopic partial menisectomy(APM) for Metabolic syndrome(MetS) patients with degenerative meniscus lesions(DMLs) during 12 month follow up. Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Knee Medial Meniscus Tears
- What is being tested?
- physical therapy and arthroscopic partial meniscectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 15 Jan 2020to 10 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
- Must be age between 35 and 70 years old;
- Clinical diagnosis of metabolic syndrome;
- Clinical diagnosis of degenerative meniscus lesions;
- Patients who has knee pain history
- Knee symptoms consistent with DMLs verified on MRI
- eligible for arthroscopic partial meniscectomy surgery by the examining orthopedic surgeons.
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
Shenzhen People's Hospital
Shenzhen, Guangdong, 121000
Yu Luo, Master, 18841609587, zhzm622@163.com
About this study
Official title: Physical Therapy vs Arthroscopic Partial Meniscectomy on the Knee Function of Metabolic Syndrome Patients With Degenerative Meniscus Lesions
The purpose was to assess knee function outcomes between physical therapy and arthroscopic partial menisectomy(APM) for Metabolic syndrome(MetS) patients with degenerative meniscus lesions(DMLs) during 12 month follow up.
Read the detailed description
Metabolic syndrome were diagnosed with abdominal obesity, insulin resistance with or without glucose intolerance, dyslipidemia or elevated blood pressure and widely prevalence all around the world.MetS patients were always correlated with knee osteoarthritis or cartilage volume loss. For MetS patients with DMLs, whether physical therapy was non-inferior to APM in knee function and MetS components was unknown.
- Conditions
- Knee Medial Meniscus Tears
- Being tested
- physical therapy, arthroscopic partial meniscectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical therapyProcedure or surgery
The exercise intervention included aerobic exercises and resistance exercise, flexibility exercises about 150 minutes for ≥2 day per week.
arthroscopic partial meniscectomyProcedure or surgery
Arthroscopic partial meniscectomy surgery procedure
| Study group | Role | What they receive |
|---|---|---|
| physical therapy | Experimental | Physical therapy mainly include aerobic exercises and resistance exercise, flexibility exercises about 150 minutes for ≥2 d/week for 6 months. Receives: Procedure: physical therapy |
| arthroscopic partial meniscectomy | Active comparator | The torn meniscus and unstable part were removed with arthroscopic instruments. Receives: Procedure: arthroscopic partial meniscectomy |
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
the 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
waist circumstance change
waist circumstance (cm)
Measured: change from baseline up to 12 months
systolic blood pressure change
systolic blood pressure /mmHg
Measured: change from baseline up to 12 months
diastolic blood pressure change
diastolic blood pressure/mmHg
Measured: change from baseline up to 12 months
serum total cholesterol (TC) change
serum total cholesterol (TC) (mmol/L)
Measured: change from baseline up to 12 months
serum triglycerides (TG) change
serum triglycerides (TG) (mmol/L)
Measured: change from baseline up to 12 months
low-density lipoprotein cholesterol (LDL-C) change
serum low-density lipoprotein cholesterol (LDL-C) (mmol/L)
Measured: change from baseline up to 12 months
high-density lipoprotein cholesterol (HDL-C) change
serum high-density lipoprotein cholesterol (HDL-C) (mmol/L)
Measured: change from baseline up to 12 months
fast blood glucose(FBG) change
serum fast blood glucose(FBG) (mmol/L)
Measured: change from baseline up to 12 months
Body mass index change
Body mass index(BMI) weight/height square (kg/㎡)
Measured: change from baseline up to 12 months
Kellgren-Lawrence (K/L) grade change
Kellgren-Lawrence (K/L) grade
Measured: change from baseline up to 12 months
Secondary outcomes (5)
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
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
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
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
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 start15 Jan 2020
- Primary completion2 Aug 2023 (estimated)
- Study completion10 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Medial Meniscus TearsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05655429
- Sponsor's protocol ID
- ShenzhenPH meniscus001
- Status last verified
- Mar 2023
- First submitted
- 2 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
- Physical Therapy vs Arthroscopic Partial Meniscectomy on the Knee Function of Metabolic Syndrome Patients With Degenerative Meniscus Lesions
- ClinicalTrials.gov ID
- NCT05655429
- Acronym / sponsor ID
- ShenzhenPH meniscus001
- Conditions
- Knee Medial Meniscus Tears
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Shenzhen People's HospitalUniversity, hospital or other
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- 2 Aug 2023 (estimated)
- Study completion
- 10 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 physical therapy and arthroscopic partial menisectomy(APM) for Metabolic syndrome(MetS) patients with degenerative meniscus lesions(DMLs) during 12 month follow up.
Detailed description
Metabolic syndrome were diagnosed with abdominal obesity, insulin resistance with or without glucose intolerance, dyslipidemia or elevated blood pressure and widely prevalence all around the world.MetS patients were always correlated with knee osteoarthritis or cartilage volume loss. For MetS patients with DMLs, whether physical therapy was non-inferior to APM in knee function and MetS components was unknown.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| physical therapy | Experimental | Procedure: physical therapyPhysical therapy mainly include aerobic exercises and resistance exercise, flexibility exercises about 150 minutes for ≥2 d/week for 6 months. |
| arthroscopic partial meniscectomy | Active comparator | Procedure: arthroscopic partial meniscectomyThe torn meniscus and unstable part were removed with arthroscopic instruments. |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 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 |
|---|---|---|
| physical therapyThe exercise intervention included aerobic exercises and resistance exercise, flexibility exercises about 150 minutes for ≥2 day per week. | Procedure or surgery | physical therapy |
| arthroscopic partial meniscectomyArthroscopic partial meniscectomy surgery procedure | Procedure or surgery | arthroscopic partial meniscectomy |
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)
the 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.
waist circumstance change
Time frame: change from baseline up to 12 months
waist circumstance (cm)
systolic blood pressure change
Time frame: change from baseline up to 12 months
systolic blood pressure /mmHg
diastolic blood pressure change
Time frame: change from baseline up to 12 months
diastolic blood pressure/mmHg
serum total cholesterol (TC) change
Time frame: change from baseline up to 12 months
serum total cholesterol (TC) (mmol/L)
serum triglycerides (TG) change
Time frame: change from baseline up to 12 months
serum triglycerides (TG) (mmol/L)
low-density lipoprotein cholesterol (LDL-C) change
Time frame: change from baseline up to 12 months
serum low-density lipoprotein cholesterol (LDL-C) (mmol/L)
high-density lipoprotein cholesterol (HDL-C) change
Time frame: change from baseline up to 12 months
serum high-density lipoprotein cholesterol (HDL-C) (mmol/L)
fast blood glucose(FBG) change
Time frame: change from baseline up to 12 months
serum fast blood glucose(FBG) (mmol/L)
Body mass index change
Time frame: change from baseline up to 12 months
Body mass index(BMI) weight/height square (kg/㎡)
Kellgren-Lawrence (K/L) grade change
Time frame: change from baseline up to 12 months
Kellgren-Lawrence (K/L) grade
5 secondary outcomes
pain score change
Time frame: change from baseline up to 12 months
symptoms score change
Time frame: change from baseline up to 12 months
activities of daily living score change
Time frame: change from baseline up to 12 months
function in sport and recreation score change
Time frame: change from baseline up to 12 months
knee related quality of life score change
Time frame: change from baseline up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
- Individual participant dataSharing planned: No
Related trials for Knee Medial Meniscus Tears
Not yet recruitingObservational study
Evaluation of Different Patterns PHMM Root Tears
Medial Meniscus Knee Injury
Recruiting
Hemi-tibial Plateau Osteotomy Combined With Arthroscopic Repair for Medial Meniscus Posterior Root Tears in Varus Knees
Knee Osteoarthristis, Meniscus Injury
Active, not recruitingObservational study
Knee Medial Collateral Ligament Recovery After Pie-Crusting Release Technique
Medial Collateral Ligament, Medial Mensical Tear
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 physical therapy and arthroscopic partial meniscectomy in people with Knee Medial Meniscus Tears, run by Shenzhen People's Hospital 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 6 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 Mar 2023. 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. 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 Hongyu Wang, Doctor (18241651300, wanghongyu790039663@126.com), or a site near the patient. 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 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 Mar 2023.