Meniscal InjuriesMATNCT07204587
Semitendinosus Autograft vs Meniscal Allograft in Post-Meniscectomy Syndrome
A study testing Autologous Semitendinosus Tendon Graft and Meniscal Allograft Transplantation (MAT) in people with Meniscal Injuries and Meniscal Tear, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
This multicenter, stratified, partially randomized clinical trial aims to compare autologous semitendinosus tendon graft and meniscal allograft transplantation (MAT) in young adults with post-meniscectomy syndrome. The meniscus plays a critical role in load distribution, shock absorption, and joint stability. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Meniscal Injuries, Meniscal Tear, Meniscus Lesion
- What is being tested?
- Autologous Semitendinosus Tendon Graft and Meniscal Allograft Transplantation (MAT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Oct 2025to 30 Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults aged 18 to 45 years
- History of partial meniscectomy > 6 months prior to enrollment
- Symptomatic post-meniscectomy syndrome (knee pain, swelling, or functional decline)
- MRI showing cartilage status ≤ Outerbridge grade 2
- Knee joint stability (or stabilized during the index surgery)
- Body mass index (BMI) < 30
- Willingness to provide written informed consent
Who cannot join
- Tibial slope > 16°
- Radiographic or arthroscopic evidence of advanced cartilage degeneration (Outerbridge > 2 or ICRS ≥ 3)
- Presence of inflammatory arthritis or systemic inflammatory joint disease
- History of cartilage repair surgery
- Malalignment > 5° not corrected
- Untreated ligamentous instability
- Any other condition judged by the investigator to compromise study participation or outcomes
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
Chang Gung memorial hospital, Taoyuan, taoyuan 333
Taoyuan City, Taoyuan, 33305
Cheng-Pang Yang, +886 0919087214, ronnie80097@gmail.com
About this study
Official title: A Stratified, Partially Randomized Study Comparing Autologous Semitendinosus Tendon Graft and Meniscal Allograft Transplantation in Young Adults With Post-Meniscectomy Syndrome
This multicenter, stratified, partially randomized clinical trial aims to compare autologous semitendinosus tendon graft and meniscal allograft transplantation (MAT) in young adults with post-meniscectomy syndrome. The meniscus plays a critical role in load distribution, shock absorption, and joint stability. After meniscectomy, insufficient meniscal tissue often leads to persistent pain, swelling, and functional decline, increasing the risk of early osteoarthritis.
Two reconstructive strategies are clinically available: MAT provides immediate biomechanical function but requires donor matching and carries higher costs, while autologous tendon graft offers stable supply and no immunologic risk but lacks long-term clinical validation.
Read more
In this study, 40 patients aged 18-45 years will be enrolled. Participants will be allocated into four groups (randomized MAT, randomized autograft, patient-preference MAT, patient-preference autograft). All procedures will use a two-tunnel fixation technique with additional internal brace support.
The primary endpoint is the improvement in KOOS (Knee Injury and Osteoarthritis Outcome Score) at 24 months postoperatively. Secondary endpoints include MRI-based assessment of graft morphology and extrusion, reoperation rate, complications, patient satisfaction, and return-to-sport time.
This trial will provide critical evidence regarding the comparative effectiveness and feasibility of tendon autograft versus meniscal allograft in real-world clinical settings, potentially informing surgical decision-making and future treatment guidelines for post-meniscectomy syndrome.
Read the detailed description
Post-meniscectomy syndrome represents a challenging condition in young adults, characterized by persistent pain, swelling, and functional impairment after partial or subtotal meniscectomy. The lack of sufficient meniscal tissue predisposes patients to abnormal tibiofemoral loading and early onset osteoarthritis. Current reconstructive options remain limited, and there is no consensus on the optimal surgical strategy.
Meniscal allograft transplantation (MAT) has been the most widely accepted method, offering immediate restoration of meniscal morphology and load-distributing capacity. However, MAT is constrained by donor availability, graft costs, and local regulations. In contrast, autologous tendon grafts-most commonly using semitendinosus-are readily available, carry no risk of rejection, and reduce cost barriers. Early biomechanical and translational studies suggest that autologous tendon grafts may adapt to meniscal-like properties, yet long-term clinical data remain scarce.
This trial employs a stratified, partially randomized design to balance methodological rigor with patient autonomy and ethical feasibility. Participants are assigned to autologous tendon graft or MAT either through randomization or patient preference, allowing assessment of outcomes under both controlled and real-world conditions. All procedures are standardized across participating centers, utilizing a two-tunnel fixation technique and augmented with an internal brace (Fibertape) to enhance graft stability.
Outcomes will be assessed over 24 months, including validated patient-reported measures (KOOS, IKDC, Tegner), MRI-based graft evaluation (volume, signal, extrusion, morphology), reoperation rates, complications, satisfaction, and return-to-sport. By integrating randomized comparison with pragmatic elements, this study aims to generate clinically applicable evidence on the relative benefits and limitations of autologous tendon graft versus MAT. The findings are expected to inform surgical decision-making, optimize patient outcomes, and guide future treatment recommendations for young patients suffering from post-meniscectomy syndrome.
- Conditions
- Meniscal Injuries, Meniscal Tear, Meniscus Lesion
- Being tested
- Autologous Semitendinosus Tendon Graft, Meniscal Allograft Transplantation (MAT)
- Keywords
- meniscal allograft, autologous tendon graft, Post-meniscectomy syndrome, Meniscus deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Semitendinosus Tendon GraftProcedure or surgery
Meniscal reconstruction will be performed using autologous semitendinosus tendon harvested from the ipsilateral leg. The graft diameter must be at least 6 mm. A two-tunnel fixation technique will be employed, securing the graft to the tibial plateau at the anatomic meniscal root sites. The graft will be shaped and positioned to mimic the native meniscal contour. Fibertape internal brace augmentation will be added to enhance fixation strength and graft stability. If concomitant anterior cruciate ligament reconstruction is indicated, the graft choice and ACL technique will be determined by the surgeon, without restriction. Postoperative rehabilitation will follow a standardized protocol across all centers.
Meniscal Allograft Transplantation (MAT)Procedure or surgery
Meniscal allograft transplantation will use size-matched, fresh-frozen allograft menisci prepared according to institutional tissue bank standards. Grafts will be fixed using a two-tunnel bone plug technique, restoring the anatomic root insertions. The allograft will be centrally positioned within the tibiofemoral compartment, and centralization sutures may be added at the discretion of the operating surgeon. All procedures will be standardized across participating centers, and postoperative rehabilitation protocols will be identical to those used in the autologous graft arm.
| Study group | Role | What they receive |
|---|---|---|
| A1 Autologous Semitendinosus Tendon Graft (Randomized) | Experimental | Patients randomized to this arm will undergo meniscal reconstruction using autologous semitendinosus tendon grafts (diameter ≥ 6 mm). Standard two-tunnel fixation technique will be applied, with Fibertape internal brace augmentation. ACL reconstruction may be performed simultaneously if indicated. Receives: Procedure: Autologous Semitendinosus Tendon Graft |
| A2 Meniscal Allograft Transplantation (Randomized) | Experimental | Patients randomized to this arm will receive size-matched fresh-frozen meniscal allografts. Fixation will be performed using the standard two-tunnel technique. Receives: Procedure: Meniscal Allograft Transplantation (MAT) |
| Meniscal Allograft Transplantation (Patient Preference) | Experimental | Patients who decline randomization but choose allograft transplantation will undergo the same surgical procedure as Arm A2, with fresh-frozen meniscal allografts. Receives: Procedure: Meniscal Allograft Transplantation (MAT) |
| Autologous Semitendinosus Tendon Graft (Patient Preference) | Experimental | Patients who decline randomization but choose autologous tendon grafting will undergo the same procedure as Arm A1, using semitendinosus tendon grafts with Fibertape internal brace augmentation. Receives: Procedure: Autologous Semitendinosus Tendon Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Injury and Osteoarthritis Outcome Score
The KOOS questionnaire evaluates knee-related symptoms, pain, activities of daily living, sports/recreation function, and knee-related quality of life. The primary endpoint is the change in KOOS total score from baseline to 24 months postoperatively.
Measured: Baseline, 6, 12, and 24 months after surgery (primary analysis at 24 months)
Secondary outcomes (7)
MRI-Based Graft Evaluation
MRI assessment of graft morphology including volume, signal distribution, shape, and extrusion, evaluated by blinded radiologists
Measured: 12 and 24 months postoperatively
IKDC (International Knee Documentation Committee) Subjective Knee Evaluation
Patient-reported outcome questionnaire assessing symptoms, daily and sports activities, and knee function
Measured: Baseline, 6, 12, and 24 months after surgery
Tegner Activity Scale
Patient-reported physical activity level, ranging from daily living to competitive sports participation.
Measured: Baseline, 6, 12, and 24 months after surgery
Reoperation Rate
Incidence of revision surgery or additional procedures related to meniscal reconstruction
Measured: Up to 24 months postoperatively
Complications
Adverse events related to the surgical intervention, including infection, graft failure, or hardware complications
Measured: Within 24 months after surgery
Patient Satisfaction
Self-reported satisfaction with surgical outcomes, measured using a 5-point Likert scale (very dissatisfied to very satisfied)
Measured: 12 and 24 months postoperatively
Return to Sport Time
Time (in months) until patients resume pre-injury level of sports participation, recorded through follow-up interviews
Measured: Up to 24 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start1 Oct 2025 (estimated)
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Meniscal InjuriesStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study uses a stratified, partially randomized parallel assignment model. Eligible patients are allocated into four groups: randomized autologous semitendinosus tendon graft, randomized meniscal allograft transplantation, patient-preference autologous tendon graft, and patient-preference meniscal allograft transplantation. Even in the randomized groups, participants retain the option to switch to their preferred treatment after allocation, ensuring both methodological rigor and ethical feasibility. This design allows assessment of comparative outcomes under randomized conditions as well as in real-world preference-based clinical practice.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07204587
- Sponsor's protocol ID
- ChangGungMH MeniscusTransplant
- Acronym
- MAT
- Status last verified
- Aug 2025
- First submitted
- 24 Sep 2025
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 1. Protection of participant privacy and confidentiality is paramount in this study involving sensitive medical data and procedures. Sharing identifiable IPD could breach the trust and privacy of these patients undergoing knee surgeries. 2. The informed consent process likely did not explicitly state or obtain approval from participants to share their individual-level data, including medical images, functional assessments, and clinical outcomes, with third parties outside the research team.
Publications
Seitz AM, Leiprecht J, Schwer J, Ignatius A, Reichel H, Kappe T. Autologous semitendinosus meniscus graft significantly improves knee joint kinematics and the tibiofemoral contact after complete lateral meniscectomy. Knee Surg Sports Traumatol Arthrosc. 2023 Jul;31(7):2956-2965. doi: 10.1007/s00167-022-07300-z. Epub 2023 Jan 5.
PubMed 36604322Ronnblad E, Rotzius P, Eriksson K. Autologous semitendinosus tendon graft could function as a meniscal transplant. Knee Surg Sports Traumatol Arthrosc. 2022 May;30(5):1520-1526. doi: 10.1007/s00167-021-06606-8. Epub 2021 Jun 8.
PubMed 34100999
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Stratified, Partially Randomized Study Comparing Autologous Semitendinosus Tendon Graft and Meniscal Allograft Transplantation in Young Adults With Post-Meniscectomy Syndrome
- ClinicalTrials.gov ID
- NCT07204587
- Acronym / sponsor ID
- MAT / ChangGungMH MeniscusTransplant
- Conditions
- Meniscal Injuries, Meniscal Tear, Meniscus Lesion
- Keywords
- meniscal allograft, autologous tendon graft, Post-meniscectomy syndrome, Meniscus deficiency
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- Karolinska University Hospital
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 2 Oct 2025 (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 multicenter, stratified, partially randomized clinical trial aims to compare autologous semitendinosus tendon graft and meniscal allograft transplantation (MAT) in young adults with post-meniscectomy syndrome. The meniscus plays a critical role in load distribution, shock absorption, and joint stability. After meniscectomy, insufficient meniscal tissue often leads to persistent pain, swelling, and functional decline, increasing the risk of early osteoarthritis.
Two reconstructive strategies are clinically available: MAT provides immediate biomechanical function but requires donor matching and carries higher costs, while autologous tendon graft offers stable supply and no immunologic risk but lacks long-term clinical validation.
In this study, 40 patients aged 18-45 years will be enrolled. Participants will be allocated into four groups (randomized MAT, randomized autograft, patient-preference MAT, patient-preference autograft). All procedures will use a two-tunnel fixation technique with additional internal brace support.
The primary endpoint is the improvement in KOOS (Knee Injury and Osteoarthritis Outcome Score) at 24 months postoperatively. Secondary endpoints include MRI-based assessment of graft morphology and extrusion, reoperation rate, complications, patient satisfaction, and return-to-sport time.
This trial will provide critical evidence regarding the comparative effectiveness and feasibility of tendon autograft versus meniscal allograft in real-world clinical settings, potentially informing surgical decision-making and future treatment guidelines for post-meniscectomy syndrome.
Detailed description
Post-meniscectomy syndrome represents a challenging condition in young adults, characterized by persistent pain, swelling, and functional impairment after partial or subtotal meniscectomy. The lack of sufficient meniscal tissue predisposes patients to abnormal tibiofemoral loading and early onset osteoarthritis. Current reconstructive options remain limited, and there is no consensus on the optimal surgical strategy.
Meniscal allograft transplantation (MAT) has been the most widely accepted method, offering immediate restoration of meniscal morphology and load-distributing capacity. However, MAT is constrained by donor availability, graft costs, and local regulations. In contrast, autologous tendon grafts-most commonly using semitendinosus-are readily available, carry no risk of rejection, and reduce cost barriers. Early biomechanical and translational studies suggest that autologous tendon grafts may adapt to meniscal-like properties, yet long-term clinical data remain scarce.
This trial employs a stratified, partially randomized design to balance methodological rigor with patient autonomy and ethical feasibility. Participants are assigned to autologous tendon graft or MAT either through randomization or patient preference, allowing assessment of outcomes under both controlled and real-world conditions. All procedures are standardized across participating centers, utilizing a two-tunnel fixation technique and augmented with an internal brace (Fibertape) to enhance graft stability.
Outcomes will be assessed over 24 months, including validated patient-reported measures (KOOS, IKDC, Tegner), MRI-based graft evaluation (volume, signal, extrusion, morphology), reoperation rates, complications, satisfaction, and return-to-sport. By integrating randomized comparison with pragmatic elements, this study aims to generate clinically applicable evidence on the relative benefits and limitations of autologous tendon graft versus MAT. The findings are expected to inform surgical decision-making, optimize patient outcomes, and guide future treatment recommendations for young patients suffering from post-meniscectomy syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- This study uses a stratified, partially randomized parallel assignment model. Eligible patients are allocated into four groups: randomized autologous semitendinosus tendon graft, randomized meniscal allograft transplantation, patient-preference autologous tendon graft, and patient-preference meniscal allograft transplantation. Even in the randomized groups, participants retain the option to switch to their preferred treatment after allocation, ensuring both methodological rigor and ethical feasibility. This design allows assessment of comparative outcomes under randomized conditions as well as in real-world preference-based clinical practice.
| Arm | Type | Receives |
|---|---|---|
| A1 Autologous Semitendinosus Tendon Graft (Randomized) | Experimental | Procedure: Autologous Semitendinosus Tendon GraftPatients randomized to this arm will undergo meniscal reconstruction using autologous semitendinosus tendon grafts (diameter ≥ 6 mm). Standard two-tunnel fixation technique will be applied, with Fibertape internal brace augmentation. ACL reconstruction may be performed simultaneously if indicated. |
| A2 Meniscal Allograft Transplantation (Randomized) | Experimental | Procedure: Meniscal Allograft Transplantation (MAT)Patients randomized to this arm will receive size-matched fresh-frozen meniscal allografts. Fixation will be performed using the standard two-tunnel technique. |
| Meniscal Allograft Transplantation (Patient Preference) | Experimental | Procedure: Meniscal Allograft Transplantation (MAT)Patients who decline randomization but choose allograft transplantation will undergo the same surgical procedure as Arm A2, with fresh-frozen meniscal allografts. |
| Autologous Semitendinosus Tendon Graft (Patient Preference) | Experimental | Procedure: Autologous Semitendinosus Tendon GraftPatients who decline randomization but choose autologous tendon grafting will undergo the same procedure as Arm A1, using semitendinosus tendon grafts with Fibertape internal brace augmentation. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Adults aged 18 to 45 years
- History of partial meniscectomy > 6 months prior to enrollment
- Symptomatic post-meniscectomy syndrome (knee pain, swelling, or functional decline)
- MRI showing cartilage status ≤ Outerbridge grade 2
- Knee joint stability (or stabilized during the index surgery)
Key exclusion criteria (7 listed)
- Tibial slope > 16°
- Radiographic or arthroscopic evidence of advanced cartilage degeneration (Outerbridge > 2 or ICRS ≥ 3)
- Presence of inflammatory arthritis or systemic inflammatory joint disease
- History of cartilage repair surgery
- Malalignment > 5° not corrected
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 |
|---|---|---|
| Autologous Semitendinosus Tendon GraftMeniscal reconstruction will be performed using autologous semitendinosus tendon harvested from the ipsilateral leg. The graft diameter must be at least 6 mm. A two-tunnel fixation technique will be employed, securing the graft to the tibial plateau at the anatomic meniscal root sites. The graft will be shaped and positioned to mimic the native meniscal contour. Fibertape internal brace augmentation will be added to enhance fixation strength and graft stability. If concomitant anterior cruciate ligament reconstruction is indicated, the graft choice and ACL technique will be determined by the surgeon, without restriction. Postoperative rehabilitation will follow a standardized protocol across all centers. | Procedure or surgery | A1 Autologous Semitendinosus Tendon Graft (Randomized), Autologous Semitendinosus Tendon Graft (Patient Preference) |
| Meniscal Allograft Transplantation (MAT)Meniscal allograft transplantation will use size-matched, fresh-frozen allograft menisci prepared according to institutional tissue bank standards. Grafts will be fixed using a two-tunnel bone plug technique, restoring the anatomic root insertions. The allograft will be centrally positioned within the tibiofemoral compartment, and centralization sutures may be added at the discretion of the operating surgeon. All procedures will be standardized across participating centers, and postoperative rehabilitation protocols will be identical to those used in the autologous graft arm. | Procedure or surgery | A2 Meniscal Allograft Transplantation (Randomized), Meniscal Allograft Transplantation (Patient Preference) |
Primary outcome
Knee Injury and Osteoarthritis Outcome Score
Time frame: Baseline, 6, 12, and 24 months after surgery (primary analysis at 24 months)
The KOOS questionnaire evaluates knee-related symptoms, pain, activities of daily living, sports/recreation function, and knee-related quality of life. The primary endpoint is the change in KOOS total score from baseline to 24 months postoperatively.
7 secondary outcomes
MRI-Based Graft Evaluation
Time frame: 12 and 24 months postoperatively
IKDC (International Knee Documentation Committee) Subjective Knee Evaluation
Time frame: Baseline, 6, 12, and 24 months after surgery
Tegner Activity Scale
Time frame: Baseline, 6, 12, and 24 months after surgery
Reoperation Rate
Time frame: Up to 24 months postoperatively
Complications
Time frame: Within 24 months after surgery
Patient Satisfaction
Time frame: 12 and 24 months postoperatively
Return to Sport Time
Time frame: Up to 24 months postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Background: PubMed 36604322Seitz AM, Leiprecht J, Schwer J, Ignatius A, Reichel H, Kappe T. Autologous semitendinosus meniscus graft significantly improves knee joint kinematics and the tibiofemoral contact after complete lateral meniscectomy. Knee Surg Sports Traumatol Arthrosc. 2023 Jul;31(7):2956-2965. doi: 10.1007/s00167-022-07300-z. Epub 2023 Jan 5.
- Background: PubMed 34100999Ronnblad E, Rotzius P, Eriksson K. Autologous semitendinosus tendon graft could function as a meniscal transplant. Knee Surg Sports Traumatol Arthrosc. 2022 May;30(5):1520-1526. doi: 10.1007/s00167-021-06606-8. Epub 2021 Jun 8.
- Individual participant dataSharing planned: No. 1. Protection of participant privacy and confidentiality is paramount in this study involving sensitive medical data and procedures. Sharing identifiable IPD could breach the trust and privacy of these patients undergoing knee surgeries. 2. The informed consent process likely did not explicitly state or obtain approval from participants to share their individual-level data, including medical images, functional assessments, and clinical outcomes, with third parties outside the research team.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous Semitendinosus Tendon Graft and Meniscal Allograft Transplantation (MAT) in people with Meniscal Injuries and Meniscal Tear, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 7 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: opening soon, as of the sponsor's last update on 2 Oct 2025. 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 Taiwan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cheng-Pang Yang (+886919087214, ronnie80097@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Injury and Osteoarthritis Outcome Score (time frame: Baseline, 6, 12, and 24 months after surgery (primary analysis at 24 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07204587, which also lists 2 linked publications.
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 2 Oct 2025.