Meniscus LesionNCT07476508
"Intra-articular Hyaluronic Acid Injection for Accelerating Functional Recovery After Knee Arthroscopy"
A study testing Standard Postoperative Rehabilitation Protocol, Oral Chondroitin Sulfate (Flextrum) and ntra-articular Hyaluronic Acid Injection (Biolevox) in people with Meniscus Lesion and Knee Injuries, run by Collegium Medicum w Bydgoszczy at 2 sites in Poland.
Trial summary
This study evaluates the effectiveness of intra-articular hyaluronic acid (HA) viscosupplementation and oral chondroitin sulfate (CS) supplementation, in combination with standard postoperative rehabilitation, on functional recovery, pain reduction, and quality of life following knee arthroscopy for medial meniscus… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Meniscus Lesion, Knee Injuries, Medial Meniscus Tear
- What is being tested?
- Standard Postoperative Rehabilitation Protocol, Oral Chondroitin Sulfate (Flextrum) and ntra-articular Hyaluronic Acid Injection (Biolevox)
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 2 sitesPoland
- Study dates
- 10 Oct 2019to 31 Mar 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years at time of enrollment
- Scheduled for knee arthroscopy for treatment of medial meniscus injury
- Torn medial meniscus with various morphology confirmed by magnetic resonance imaging (MRI)
- Positive clinical examination findings specific for medial meniscus tear OR mechanical symptoms (locking, catching)
- Failed conservative treatment for at least 3 months including physical therapy and/or anti-inflammatory medications
- Grade 0 or Grade 1 osteoarthritis according to Kellgren-Lawrence radiographic classification scale at baseline visit
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- Able and willing to provide written informed consent
- Able to comply with study procedures and attend all follow-up visits
- Willing to adhere to postoperative rehabilitation protocol
Who cannot join
- Prior surgery on the ipsilateral knee (except previous knee arthroscopy for partial meniscectomy and/or chondroplasty)
- Prior surgery on the contralateral knee (except previous knee arthroscopy for partial meniscectomy and/or chondroplasty)
- Intraoperative diagnosis of anterior cruciate ligament (ACL) injury requiring reconstruction
- History of concomitant knee procedures including: ligamentous repair or reconstruction, high tibial osteotomy, distal femoral osteotomy, hardware removal, irrigation and debridement for infection, microfracture procedures, autologous chondrocyte implantation (ACI), osteochondral autograft transfer (OATS), or osteochondral allograft transfer
- Axial knee deformity (varus or valgus malalignment)
- Radiological signs of knee osteoarthritis Grade 2 or higher on Kellgren-Lawrence scale
Show all 13Show fewer
- Inflammatory arthritis (rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, etc.)
- History of septic arthritis in either knee
- Known hypersensitivity or allergy to hyaluronic acid products, chondroitin sulfate, or any study product components
- Active infection or skin disease at the injection site
- Bleeding disorders or current anticoagulation therapy that cannot be safely interrupted
- Pregnancy or lactation - Current participation in another interventional clinical trial
- Any condition that, in the opinion of the investigator, would compromise the participant's ability to participate in the study or potentially confound study results
Trial locations and contacts
2 sites in 1 country.
Poland2 sites
Department of Orthopedics Collegium Medicum, Nicolaus Copernicus University
Bydgoszcz
Department of Orthopaedics and Traumatology, Regional Hospita
Grudziądz
About this study
Official title: "Intra-articular Hyaluronic Acid Injection Significantly Accelerates Functional Recovery After Knee Arthroscopy: A Prospective Randomized Controlled Trial"
This study evaluates the effectiveness of intra-articular hyaluronic acid (HA) viscosupplementation and oral chondroitin sulfate (CS) supplementation, in combination with standard postoperative rehabilitation, on functional recovery, pain reduction, and quality of life following knee arthroscopy for medial meniscus injury. Knee arthroscopy is commonly performed for meniscal tears, but the extensive joint irrigation during the procedure removes naturally occurring synovial fluid, potentially prolonging recovery. Hyaluronic acid is the main component of synovial fluid and plays crucial roles in joint lubrication, shock absorption, and cartilage protection. This prospective, randomized, three-arm controlled trial will enroll approximately 290 patients undergoing arthroscopy for medial meniscus injury. Participants will be randomized into three groups: (1) standard rehabilitation alone (Control), (2) rehabilitation plus oral CS supplementation (1200mg CS and 40mg Vitamin C daily for 12 weeks), or (3) rehabilitation plus two intra-articular HA injections (Biolevox™ HA 2.2%, administered at 2 weeks and 6 weeks post-arthroscopy). The primary outcome is knee function assessed using the Knee Injury and Osteoarthritis Outcome Score (KOOS) at 12 weeks. Secondary outcomes include quality of life (WHOQoL-BREF questionnaire) and safety assessments. The study hypothesis is that viscosupplementation with medium molecular weight HA will result in superior functional outcomes compared with oral supplementation or standard rehabilitation alone.
Read the detailed description
Knee arthroscopy is the most commonly performed orthopedic procedure. Although it offers advantages over open surgery, including reduced postoperative pain and faster recovery, the procedure inevitably involves extensive joint irrigation which removes naturally occurring synovial fluid. Synovial fluid plays a crucial role in joint lubrication and shock absorption. Its reduction following arthroscopy increases friction between articular surfaces, intensifying pain and potentially prolonging rehabilitation. Recovery typically requires 4-6 weeks, during which patients may experience persistent pain and limited joint function. Viscosupplementation with hyaluronic acid (HA) has emerged as a promising approach to addressing post-arthroscopic joint dysfunction. HA is the main non-protein component of synovial fluid, forming a protective layer on articular cartilage, reducing friction and helping maintain tissue resistance to compressive forces. Beyond mechanical effects, HA provides biological benefits including stimulation of endogenous HA synthesis, reduction of proteoglycan loss, and protection of chondrocytes from apoptosis. Oral chondroitin sulfate (CS) supplementation has also been proposed as an adjunctive therapy, with proposed mechanisms including support for cartilage homeostasis through stimulation of proteoglycan and collagen synthesis.
- Conditions
- Meniscus Lesion, Knee Injuries, Medial Meniscus Tear
- Being tested
- Standard Postoperative Rehabilitation Protocol, Oral Chondroitin Sulfate (Flextrum), ntra-articular Hyaluronic Acid Injection (Biolevox)
- Medical subject headings
- Knee Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Postoperative Rehabilitation ProtocolBehavioural
Evidence-based 12-week progressive rehabilitation program consisting of four phases progressing from joint protection through functional strengthening, including partial/full weight-bearing progression, ROM exercises, quadriceps/hamstring strengthening, balance training, and functional exercises.
Arm Group Labels: Control - Standard Rehabilitation; Oral Chondroitin Sulfate Supplementation; Intra-articular Hyaluronic Acid Viscosupplementation
Oral Chondroitin Sulfate (Flextrum)Dietary supplement
Flextrum tablets containing 1200mg chondroitin sulfate and 40mg Vitamin C taken orally once daily for 12 weeks starting immediately post-arthroscopy.
Arm Group Labels: Oral Chondroitin Sulfate Supplementation
ntra-articular Hyaluronic Acid Injection (Biolevox)Device
Biolevox™ HA 2.2% (concentration 22mg/mL, volume 2mL per injection, molecular weight 1400-2400 kDa, bacterial fermentation origin) administered via ultrasound-guided intra-articular injection using lateral mid-patellar approach with knee in full extension. Two injections total: first at 2 weeks post-arthroscopy and second at 6 weeks post-arthroscopy.
Manufacturer: Biovico Sp. z o.o., Gdynia, Poland Arm Group Labels: Intra-articular Hyaluronic Acid Viscosupplementation
| Study group | Role | What they receive |
|---|---|---|
| Control - Standard Rehabilitation | Active comparator | Participants receive standard postoperative rehabilitation protocol over 12 weeks consisting of four sequential phases: Phase I (weeks 0-3) - joint protection, partial weight-bearing with brace and crutches, swelling management, patellar mobilization, knee ROM exercises 0-90°, quadriceps isometric exercises, straight-leg raises; Phase II (weeks 3-6) - partial weight-bearing continuation, progressive ROM restoration using stationary bicycle, calf strengthening, balance training; Phase III (weeks 6-9) - full weight-bearing progression once adequate quadriceps control achieved, progressive strengthening exercises (partial squats 0-60° knee flexion, hamstring strengthening), cardiovascular conditioning; Phase IV (weeks 9-12) - advanced functional strengthening including lunges, step-based exercises, single-leg progressions. Receives: Behavioral: Standard Postoperative Rehabilitation Protocol |
| Oral Chondroitin Sulfate Supplementation | Experimental | Participants receive standard postoperative rehabilitation protocol (identical to Control arm) PLUS oral chondroitin sulfate supplementation (Flextrum: 1200mg chondroitin sulfate and 40mg Vitamin C) taken daily for 12 weeks. Receives: Behavioral: Standard Postoperative Rehabilitation Protocol; Dietary Supplement: Oral Chondroitin Sulfate (Flextrum) |
| Intra-articular Hyaluronic Acid Viscosupplementation | Experimental | Participants receive standard postoperative rehabilitation protocol (identical to Control arm) PLUS two intra-articular hyaluronic acid injections (Biolevox™ HA 2.2%, concentration 22mg/mL, volume 2mL, molecular weight 1400-2400 kDa) administered at 2 weeks and 6 weeks post-arthroscopy. Injections are performed under real-time ultrasound guidance using a lateral mid-patellar portal with the knee in full extension, administered by a single certified orthopedic physician. Receives: Behavioral: Standard Postoperative Rehabilitation Protocol; Device: ntra-articular Hyaluronic Acid Injection (Biolevox) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) Total Score
The KOOS is a validated 42-item patient-reported outcome measure evaluating five domains: Pain (9 items), Other Symptoms (7 items), Function in Daily Living (17 items), Function in Sport and Recreation (5 items), and Knee-related Quality of Life (4 items). Each item is scored on a 0-4 Likert scale. Scores are transformed to 0-100 scale, where 0 represents extreme knee problems, and 100 represents no knee problems. The KOOS Total Score is calculated as the average of all five domain scores. Higher scores indicate better outcomes.
Measured: Baseline (pre-surgery) and 12 weeks post-arthroscopy
Secondary outcomes (6)
Change in KOOS Pain Subscale Score
The KOOS Pain subscale consists of 9 items assessing pain frequency and severity during various activities. Scores range from 0 (extreme pain) to 100 (no pain). Higher scores indicate less pain and better outcomes.
Measured: Baseline (pre-surgery) and 12 weeks post-arthroscopy
Change in World Health Organization Quality of Life-BREF (WHOQoL-BREF) - Physical Health Domain
The WHOQoL-BREF is a 26-item questionnaire evaluating health-related quality of life. The Physical Health domain assesses activities of daily living, dependence on medications or medical aids, energy and fatigue, mobility, pain and discomfort, sleep and rest, and work capacity. Domain scores are transformed to a 0-100 scale, where higher scores indicate better quality of life.
Measured: Baseline (pre-surgery) and 12 weeks post-arthroscopy
Change in WHOQoL-BREF - Social Relationships Domain
The Social Relationships domain of WHOQoL-BREF assesses personal relationships, social support, and sexual activity. Scores transformed to a 0-100 scale, where higher scores indicate better social relationships.
Measured: Baseline (pre-surgery) and 12 weeks post-arthroscopy
Change in WHOQoL-BREF - Environment Domain
The Environment domain of WHOQoL-BREF assesses financial resources, freedom/physical safety/security, health and social care accessibility and quality, home environment, opportunities for acquiring information and skills, participation in and opportunities for recreation/leisure activities, physical environment, and transport. Scores transformed to 0-100 scale where higher scores indicate better environmental quality of life.
Measured: Baseline (pre-surgery) and 12 weeks post-arthroscopy
Incidence of Adverse Events
Number of participants experiencing any adverse events, including but not limited to: infection, joint effusion, allergic reactions, injection-site complications, gastrointestinal symptoms, or any other treatment-related adverse effects. Safety will be assessed through participant self-report and clinical examination.
Measured: Throughout the 12-week study period
Incidence of Serious Adverse Events
Number of participants experiencing serious adverse events (SAEs) defined as any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.
Measured: Throughout 12-week study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start10 Oct 2019
- Primary completion31 Dec 2021
- Study completion31 Mar 2022
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- Collegium Medicum w Bydgoszczy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Zabrzyńska, Collegium Medicum w Bydgoszczy
- Investigators
- Maria Zabrzyńska, MD PhD, Principal investigator, Department of Family Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07476508
- Sponsor's protocol ID
- 1.0 10.10.2019
- Status last verified
- Mar 2026
- First submitted
- 12 Mar 2026
- Last updated
- 17 Mar 2026
- Results posted
- No
- 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 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Intra-articular Hyaluronic Acid Injection Significantly Accelerates Functional Recovery After Knee Arthroscopy: A Prospective Randomized Controlled Trial"
- ClinicalTrials.gov ID
- NCT07476508
- Acronym / sponsor ID
- 1.0 10.10.2019
- Conditions
- Meniscus Lesion, Knee Injuries, Medial Meniscus Tear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- Collegium Medicum w BydgoszczyUniversity, hospital or other
- Study start
- 10 Oct 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 17 Mar 2026 (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.
This study evaluates the effectiveness of intra-articular hyaluronic acid (HA) viscosupplementation and oral chondroitin sulfate (CS) supplementation, in combination with standard postoperative rehabilitation, on functional recovery, pain reduction, and quality of life following knee arthroscopy for medial meniscus injury. Knee arthroscopy is commonly performed for meniscal tears, but the extensive joint irrigation during the procedure removes naturally occurring synovial fluid, potentially prolonging recovery. Hyaluronic acid is the main component of synovial fluid and plays crucial roles in joint lubrication, shock absorption, and cartilage protection. This prospective, randomized, three-arm controlled trial will enroll approximately 290 patients undergoing arthroscopy for medial meniscus injury. Participants will be randomized into three groups: (1) standard rehabilitation alone (Control), (2) rehabilitation plus oral CS supplementation (1200mg CS and 40mg Vitamin C daily for 12 weeks), or (3) rehabilitation plus two intra-articular HA injections (Biolevox™ HA 2.2%, administered at 2 weeks and 6 weeks post-arthroscopy). The primary outcome is knee function assessed using the Knee Injury and Osteoarthritis Outcome Score (KOOS) at 12 weeks. Secondary outcomes include quality of life (WHOQoL-BREF questionnaire) and safety assessments. The study hypothesis is that viscosupplementation with medium molecular weight HA will result in superior functional outcomes compared with oral supplementation or standard rehabilitation alone.
Detailed description
Knee arthroscopy is the most commonly performed orthopedic procedure. Although it offers advantages over open surgery, including reduced postoperative pain and faster recovery, the procedure inevitably involves extensive joint irrigation which removes naturally occurring synovial fluid. Synovial fluid plays a crucial role in joint lubrication and shock absorption. Its reduction following arthroscopy increases friction between articular surfaces, intensifying pain and potentially prolonging rehabilitation. Recovery typically requires 4-6 weeks, during which patients may experience persistent pain and limited joint function. Viscosupplementation with hyaluronic acid (HA) has emerged as a promising approach to addressing post-arthroscopic joint dysfunction. HA is the main non-protein component of synovial fluid, forming a protective layer on articular cartilage, reducing friction and helping maintain tissue resistance to compressive forces. Beyond mechanical effects, HA provides biological benefits including stimulation of endogenous HA synthesis, reduction of proteoglycan loss, and protection of chondrocytes from apoptosis. Oral chondroitin sulfate (CS) supplementation has also been proposed as an adjunctive therapy, with proposed mechanisms including support for cartilage homeostasis through stimulation of proteoglycan and collagen synthesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control - Standard Rehabilitation | Active comparator | Behavioral: Standard Postoperative Rehabilitation ProtocolParticipants receive standard postoperative rehabilitation protocol over 12 weeks consisting of four sequential phases: Phase I (weeks 0-3) - joint protection, partial weight-bearing with brace and crutches, swelling management, patellar mobilization, knee ROM exercises 0-90°, quadriceps isometric exercises, straight-leg raises; Phase II (weeks 3-6) - partial weight-bearing continuation, progressive ROM restoration using stationary bicycle, calf strengthening, balance training; Phase III (weeks 6-9) - full weight-bearing progression once adequate quadriceps control achieved, progressive strengthening exercises (partial squats 0-60° knee flexion, hamstring strengthening), cardiovascular conditioning; Phase IV (weeks 9-12) - advanced functional strengthening including lunges, step-based exercises, single-leg progressions. |
| Oral Chondroitin Sulfate Supplementation | Experimental | Behavioral: Standard Postoperative Rehabilitation Protocol, Dietary Supplement: Oral Chondroitin Sulfate (Flextrum)Participants receive standard postoperative rehabilitation protocol (identical to Control arm) PLUS oral chondroitin sulfate supplementation (Flextrum: 1200mg chondroitin sulfate and 40mg Vitamin C) taken daily for 12 weeks. |
| Intra-articular Hyaluronic Acid Viscosupplementation | Experimental | Behavioral: Standard Postoperative Rehabilitation Protocol, Device: ntra-articular Hyaluronic Acid Injection (Biolevox)Participants receive standard postoperative rehabilitation protocol (identical to Control arm) PLUS two intra-articular hyaluronic acid injections (Biolevox™ HA 2.2%, concentration 22mg/mL, volume 2mL, molecular weight 1400-2400 kDa) administered at 2 weeks and 6 weeks post-arthroscopy. Injections are performed under real-time ultrasound guidance using a lateral mid-patellar portal with the knee in full extension, administered by a single certified orthopedic physician. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18-65 years at time of enrollment
- Scheduled for knee arthroscopy for treatment of medial meniscus injury
- Torn medial meniscus with various morphology confirmed by magnetic resonance imaging (MRI)
- Positive clinical examination findings specific for medial meniscus tear OR mechanical symptoms (locking, catching)
- Failed conservative treatment for at least 3 months including physical therapy and/or anti-inflammatory medications
Key exclusion criteria (13 listed)
- Prior surgery on the ipsilateral knee (except previous knee arthroscopy for partial meniscectomy and/or chondroplasty)
- Prior surgery on the contralateral knee (except previous knee arthroscopy for partial meniscectomy and/or chondroplasty)
- Intraoperative diagnosis of anterior cruciate ligament (ACL) injury requiring reconstruction
- History of concomitant knee procedures including: ligamentous repair or reconstruction, high tibial osteotomy, distal femoral osteotomy, hardware removal, irrigation and debridement for infection, microfracture procedures, autologous chondrocyte implantation (ACI), osteochondral autograft transfer (OATS), or osteochondral allograft transfer
- Axial knee deformity (varus or valgus malalignment)
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 |
|---|---|---|
| Standard Postoperative Rehabilitation ProtocolEvidence-based 12-week progressive rehabilitation program consisting of four phases progressing from joint protection through functional strengthening, including partial/full weight-bearing progression, ROM exercises, quadriceps/hamstring strengthening, balance training, and functional exercises. Arm Group Labels: Control - Standard Rehabilitation; Oral Chondroitin Sulfate Supplementation; Intra-articular Hyaluronic Acid Viscosupplementation | Behavioural | Control - Standard Rehabilitation, Intra-articular Hyaluronic Acid Viscosupplementation, Oral Chondroitin Sulfate Supplementation |
| Oral Chondroitin Sulfate (Flextrum)Flextrum tablets containing 1200mg chondroitin sulfate and 40mg Vitamin C taken orally once daily for 12 weeks starting immediately post-arthroscopy. Arm Group Labels: Oral Chondroitin Sulfate Supplementation | Dietary supplement | Oral Chondroitin Sulfate Supplementation |
| ntra-articular Hyaluronic Acid Injection (Biolevox)Biolevox™ HA 2.2% (concentration 22mg/mL, volume 2mL per injection, molecular weight 1400-2400 kDa, bacterial fermentation origin) administered via ultrasound-guided intra-articular injection using lateral mid-patellar approach with knee in full extension. Two injections total: first at 2 weeks post-arthroscopy and second at 6 weeks post-arthroscopy. Manufacturer: Biovico Sp. z o.o., Gdynia, Poland Arm Group Labels: Intra-articular Hyaluronic Acid Viscosupplementation | Device | Intra-articular Hyaluronic Acid Viscosupplementation |
Primary outcome
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) Total Score
Time frame: Baseline (pre-surgery) and 12 weeks post-arthroscopy
The KOOS is a validated 42-item patient-reported outcome measure evaluating five domains: Pain (9 items), Other Symptoms (7 items), Function in Daily Living (17 items), Function in Sport and Recreation (5 items), and Knee-related Quality of Life (4 items). Each item is scored on a 0-4 Likert scale. Scores are transformed to 0-100 scale, where 0 represents extreme knee problems, and 100 represents no knee problems. The KOOS Total Score is calculated as the average of all five domain scores. Higher scores indicate better outcomes.
6 secondary outcomes
Change in KOOS Pain Subscale Score
Time frame: Baseline (pre-surgery) and 12 weeks post-arthroscopy
Change in World Health Organization Quality of Life-BREF (WHOQoL-BREF) - Physical Health Domain
Time frame: Baseline (pre-surgery) and 12 weeks post-arthroscopy
Change in WHOQoL-BREF - Social Relationships Domain
Time frame: Baseline (pre-surgery) and 12 weeks post-arthroscopy
Change in WHOQoL-BREF - Environment Domain
Time frame: Baseline (pre-surgery) and 12 weeks post-arthroscopy
Incidence of Adverse Events
Time frame: Throughout the 12-week study period
Incidence of Serious Adverse Events
Time frame: Throughout 12-week study period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- 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.
Maria Zabrzyńska, MD PhD principal investigator
Department of Family Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Postoperative Rehabilitation Protocol, Oral Chondroitin Sulfate (Flextrum) and ntra-articular Hyaluronic Acid Injection (Biolevox) in people with Meniscus Lesion and Knee Injuries, run by Collegium Medicum w Bydgoszczy at 2 sites in Poland.
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 9 inclusion and 13 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: finished, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) Total Score (time frame: Baseline (pre-surgery) and 12 weeks post-arthroscopy). 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 17 Mar 2026.