Osteochondral Lesions of Knee3D-PR-PBGNCT07312175
3D-Printed Grafts for Knee Cartilage Repair
A study testing 3D-Printed Scaffold-Assisted PRP Combined with Autologous Periosteal-Bone Grafting and 3D Printing-Assisted Autologous Periosteal-Bone Grafting in people with Osteochondral Lesions of Knee and Osteo Arthritis, run by Second Affiliated Hospital of Nanchang University at 1 site in China.
Trial summary
Research Title:A study on 3D printing-assisted platelet-rich plasma combined with autologous periosteum-bone grafting in the treatment of knee cartilage injury Objectives:(1) To evaluate the accuracy of cartilage damage repair by measuring the chimerism and surface curvature matching degree of 3D printing… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Osteochondral Lesions of Knee, Osteo Arthritis
- What is being tested?
- 3D-Printed Scaffold-Assisted PRP Combined with Autologous Periosteal-Bone Grafting and 3D Printing-Assisted Autologous Periosteal-Bone Grafting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2025to 30 Dec 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years;
- Body Mass Index (BMI) 18-30 kg/m²;
- Imaging-confirmed knee cartilage damage >2 cm² with International Cartilage Repair Society (ICRS) grade 4;
- No significant lower limb alignment abnormalities;
- No prior local drug injections in the knee joint within the past year.
Who cannot join
- Significant osteoporosis;
- Individuals with immature bones;
- Those with poor mechanical alignment;
- Presence of meniscus injury, cruciate ligament or collateral ligament rupture, or incomplete healing following surgery for any of these conditions;
- Severe knee joint effusion;
- Use of corticosteroids or immunosuppressive agents;
- Poor general health, alcoholism, or substance abuse;
- Previous treatment with autologous blood products or stem cell preparations.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study on 3D Printing-assisted Platelet-rich Plasma Combined With Autologous Periosteum-bone Grafting in the Treatment of Knee Cartilage Injury
Research Title:A study on 3D printing-assisted platelet-rich plasma combined with autologous periosteum-bone grafting in the treatment of knee cartilage injury Objectives:(1) To evaluate the accuracy of cartilage damage repair by measuring the chimerism and surface curvature matching degree of 3D printing reconstruction. (2) 3D printing assisted platelerichplasma (PRP) combined with autologous periosteumBone grafting in patients with knee cartilage injury was evaluated for functional and imaging scores to evaluate the clinical effect and cartilage repair effect.
Design Type:Prospective randomized controlled trial Research Objects:Unilateral knee cartilage injury area>2CM2, international cartilagerepair society (ICRS) grade 3-4 patients Sample size: 60 cases (30 patients with 3D printing-assisted autologous periosteum-bone grafting, 3D printing-assisted PRP combined with autologous periosteum.) - 30 patients with bone grafting).Selection Criteria:(1) Age 18~65 years old; (2) The body mass index (BMI) is 18~30kg/m2 ； (3) Knee cartilage injury confirmed by imaging examination, knee cartilage injury 2>cm2, ICRS grade 3-4; (4) There is no obvious abnormality in the lower limb force line; (5) No other drug injection or surgical treatment has been performed locally in the knee joint in the past 1 year.
Observation indicators:(1) Clinical function(2) Imaging evaluation: Bilateral knee MRI examination was performed on the second day after surgery Statistical analysis methods:SPSS software was used for data analysis.
Read the detailed description
Research Title:A study on 3D printing-assisted platelet-rich plasma combined with autologous periosteum-bone grafting in the treatment of knee cartilage injury Objectives:(1) To evaluate the accuracy of cartilage damage repair by measuring the chimerism and surface curvature matching degree of 3D printing reconstruction. (2) 3D printing assisted platelerichplasma (PRP) combined with autologous periosteumBone grafting in patients with knee cartilage injury was evaluated for functional and imaging scores to evaluate the clinical effect and cartilage repair effect.
Design Type:Prospective randomized controlled trial Research Objects:Unilateral knee cartilage injury area>2CM2, international cartilagerepair society (ICRS) grade 3-4 patients Sample size: 60 cases (30 patients with 3D printing-assisted autologous periosteum-bone grafting, 3D printing-assisted PRP combined with autologous periosteum.) - 30 patients with bone grafting).Selection Criteria:(1) Age 18~65 years old; (2) The body mass index (BMI) is 18~30kg/m2 ； (3) Knee cartilage injury confirmed by imaging examination, knee cartilage injury 2>cm2, ICRS grade 3-4; (4) There is no obvious abnormality in the lower limb force line; (5) No other drug injection or surgical treatment has been performed locally in the knee joint in the past 1 year.
Observation indicators:(1) Clinical function: Knee joint obtained by outpatient follow-up, written questionnaires, or by telephone by trained medical professionals before surgery and 1, 3, 6, and 12 months after surgery Lysholm score, Tegner exercise ability score, and pain numeric score were used to assess the improvement of symptoms and function. (2) Imaging evaluation: Bilateral knee MRI examination was performed on the second day after surgery, and the anatomical reconstruction was evaluated by mirror technology, including the chimerism of the bone bone interface between the graft and the host bone, and the match of the surface curvature of the graft and the recipient area. Magnetic resonanceobservationofcartilagerepairtissue observation (magneticresonanceobservationofcartilagerepairtissue, MOCART) scoring method scored MRI before surgery and 1 year after surgery to evaluate cartilage repair.
Statistical analysis methods:SPSS software was used for data analysis. The continuous data were expressed in (±s), and the normality test was performed, and the SNK test was used for comparison between groups. Repeated measures analysis of variance was used for comparison of time data before and after intervention within the group, and paired sample f test was used for comparison at two time points. If the data does not meet the normal distribution, the logarithmic transformation is analyzed again. The X2 test was used for the counting data. P<0.05 was a statistically significant difference.
- Conditions
- Osteochondral Lesions of Knee, Osteo Arthritis
- Being tested
- 3D-Printed Scaffold-Assisted PRP Combined with Autologous Periosteal-Bone Grafting, 3D Printing-Assisted Autologous Periosteal-Bone Grafting
- Keywords
- Autologous osteoperiosteal transplantation, Massive, Osteochondral lesions, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D-Printed Scaffold-Assisted PRP Combined with Autologous Periosteal-Bone GraftingProcedure or surgery
3D-Printed Scaffold-Assisted PRP Combined with Autologous Periosteal-Bone Grafting
3D Printing-Assisted Autologous Periosteal-Bone GraftingProcedure or surgery
3D Printing-Assisted Autologous Periosteal-Bone Grafting
| Study group | Role | What they receive |
|---|---|---|
| 3D-Printed Scaffold-Assisted PRP Combined with Autologous Periosteal-Bone Grafting | Experimental | 3D-Printed Scaffold-Assisted PRP Combined with Autologous Periosteal-Bone Grafting Receives: Procedure: 3D-Printed Scaffold-Assisted PRP Combined with Autologous Periosteal-Bone Grafting; Procedure: 3D Printing-Assisted Autologous Periosteal-Bone Grafting |
| 3D Printing-Assisted Autologous Periosteal-Bone Grafting | Other | 3D Printing-Assisted Autologous Periosteal-Bone Grafting Receives: Procedure: 3D-Printed Scaffold-Assisted PRP Combined with Autologous Periosteal-Bone Grafting; Procedure: 3D Printing-Assisted Autologous Periosteal-Bone Grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical function
(1) Clinical function: Knee joint obtained by outpatient follow-up, written questionnaires, or by telephone by trained medical professionals before surgery and 1, 3, 6, and 12 months after surgery Lysholm score, Tegner exercise ability score, and pain numeric score were used to assess the improvement of symptoms and function.Lysholm score：minimum：0，maximum：80，a higher score represents a better outcome；Tegner exercise ability score：minimum：0，maximum：80，a higher score represents a better outcome；pain numeric score：minimum：0，maximum：10，a higher score represents a worse outcome.）
Measured: 1 year
Secondary outcomes (1)
Imaging evaluation
Imaging evaluation: Bilateral knee MRI examination was performed on the second day after surgery, and the anatomical reconstruction was evaluated by mirror technology, including the chimerism of the bone bone interface between the graft and the host bone, and the match of the surface curvature of the graft and the recipient area. Magnetic resonanceobservationofcartilagerepairtissue observation (magneticresonanceobservationofcartilagerepairtissue, MOCART) scoring method scored MRI before surgery and 1 year after surgery to evaluate cartilage repair.MOCART：minimum：0，maximum：10, a higher score represents a better outcome.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2025
- Study start1 Aug 2025
- Primary completion30 Dec 2029 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteochondral Lesions of KneeStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Nanchang UniversityThe 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07312175
- Sponsor's protocol ID
- I-2025126
- Acronym
- 3D-PR-PBG
- Status last verified
- Aug 2025
- First submitted
- 16 Nov 2025
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- 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 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on 3D Printing-assisted Platelet-rich Plasma Combined With Autologous Periosteum-bone Grafting in the Treatment of Knee Cartilage Injury
- ClinicalTrials.gov ID
- NCT07312175
- Acronym / sponsor ID
- 3D-PR-PBG / I-2025126
- Conditions
- Osteochondral Lesions of Knee, Osteo Arthritis
- Keywords
- Autologous osteoperiosteal transplantation, Massive, Osteochondral lesions, Knee
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Nanchang UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 30 Dec 2029 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 31 Dec 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.
Research Title:A study on 3D printing-assisted platelet-rich plasma combined with autologous periosteum-bone grafting in the treatment of knee cartilage injury Objectives:(1) To evaluate the accuracy of cartilage damage repair by measuring the chimerism and surface curvature matching degree of 3D printing reconstruction. (2) 3D printing assisted platelerichplasma (PRP) combined with autologous periosteumBone grafting in patients with knee cartilage injury was evaluated for functional and imaging scores to evaluate the clinical effect and cartilage repair effect.
Design Type:Prospective randomized controlled trial Research Objects:Unilateral knee cartilage injury area>2CM2, international cartilagerepair society (ICRS) grade 3-4 patients Sample size: 60 cases (30 patients with 3D printing-assisted autologous periosteum-bone grafting, 3D printing-assisted PRP combined with autologous periosteum.) - 30 patients with bone grafting).Selection Criteria:(1) Age 18~65 years old; (2) The body mass index (BMI) is 18~30kg/m2 ； (3) Knee cartilage injury confirmed by imaging examination, knee cartilage injury 2>cm2, ICRS grade 3-4; (4) There is no obvious abnormality in the lower limb force line; (5) No other drug injection or surgical treatment has been performed locally in the knee joint in the past 1 year.
Observation indicators:(1) Clinical function(2) Imaging evaluation: Bilateral knee MRI examination was performed on the second day after surgery Statistical analysis methods:SPSS software was used for data analysis.
Detailed description
Research Title:A study on 3D printing-assisted platelet-rich plasma combined with autologous periosteum-bone grafting in the treatment of knee cartilage injury Objectives:(1) To evaluate the accuracy of cartilage damage repair by measuring the chimerism and surface curvature matching degree of 3D printing reconstruction. (2) 3D printing assisted platelerichplasma (PRP) combined with autologous periosteumBone grafting in patients with knee cartilage injury was evaluated for functional and imaging scores to evaluate the clinical effect and cartilage repair effect.
Design Type:Prospective randomized controlled trial Research Objects:Unilateral knee cartilage injury area>2CM2, international cartilagerepair society (ICRS) grade 3-4 patients Sample size: 60 cases (30 patients with 3D printing-assisted autologous periosteum-bone grafting, 3D printing-assisted PRP combined with autologous periosteum.) - 30 patients with bone grafting).Selection Criteria:(1) Age 18~65 years old; (2) The body mass index (BMI) is 18~30kg/m2 ； (3) Knee cartilage injury confirmed by imaging examination, knee cartilage injury 2>cm2, ICRS grade 3-4; (4) There is no obvious abnormality in the lower limb force line; (5) No other drug injection or surgical treatment has been performed locally in the knee joint in the past 1 year.
Observation indicators:(1) Clinical function: Knee joint obtained by outpatient follow-up, written questionnaires, or by telephone by trained medical professionals before surgery and 1, 3, 6, and 12 months after surgery Lysholm score, Tegner exercise ability score, and pain numeric score were used to assess the improvement of symptoms and function. (2) Imaging evaluation: Bilateral knee MRI examination was performed on the second day after surgery, and the anatomical reconstruction was evaluated by mirror technology, including the chimerism of the bone bone interface between the graft and the host bone, and the match of the surface curvature of the graft and the recipient area. Magnetic resonanceobservationofcartilagerepairtissue observation (magneticresonanceobservationofcartilagerepairtissue, MOCART) scoring method scored MRI before surgery and 1 year after surgery to evaluate cartilage repair.
Statistical analysis methods:SPSS software was used for data analysis. The continuous data were expressed in (±s), and the normality test was performed, and the SNK test was used for comparison between groups. Repeated measures analysis of variance was used for comparison of time data before and after intervention within the group, and paired sample f test was used for comparison at two time points. If the data does not meet the normal distribution, the logarithmic transformation is analyzed again. The X2 test was used for the counting data. P<0.05 was a statistically significant difference.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3D-Printed Scaffold-Assisted PRP Combined with Autologous Periosteal-Bone Grafting | Experimental | Procedure: 3D-Printed Scaffold-Assisted PRP Combined with Autologous Periosteal-Bone Grafting, Procedure: 3D Printing-Assisted Autologous Periosteal-Bone Grafting3D-Printed Scaffold-Assisted PRP Combined with Autologous Periosteal-Bone Grafting |
| 3D Printing-Assisted Autologous Periosteal-Bone Grafting | Other | Procedure: 3D-Printed Scaffold-Assisted PRP Combined with Autologous Periosteal-Bone Grafting, Procedure: 3D Printing-Assisted Autologous Periosteal-Bone Grafting3D Printing-Assisted Autologous Periosteal-Bone Grafting |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-65 years;
- Body Mass Index (BMI) 18-30 kg/m²;
- Imaging-confirmed knee cartilage damage >2 cm² with International Cartilage Repair Society (ICRS) grade 4;
- No significant lower limb alignment abnormalities;
- No prior local drug injections in the knee joint within the past year.
Key exclusion criteria (8 listed)
- Significant osteoporosis;
- Individuals with immature bones;
- Those with poor mechanical alignment;
- Presence of meniscus injury, cruciate ligament or collateral ligament rupture, or incomplete healing following surgery for any of these conditions;
- Severe knee joint effusion;
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 |
|---|---|---|
| 3D-Printed Scaffold-Assisted PRP Combined with Autologous Periosteal-Bone Grafting3D-Printed Scaffold-Assisted PRP Combined with Autologous Periosteal-Bone Grafting | Procedure or surgery | 3D Printing-Assisted Autologous Periosteal-Bone Grafting, 3D-Printed Scaffold-Assisted PRP Combined with Autologous Periosteal-Bone Grafting |
| 3D Printing-Assisted Autologous Periosteal-Bone Grafting3D Printing-Assisted Autologous Periosteal-Bone Grafting | Procedure or surgery | 3D Printing-Assisted Autologous Periosteal-Bone Grafting, 3D-Printed Scaffold-Assisted PRP Combined with Autologous Periosteal-Bone Grafting |
Primary outcome
Clinical function
Time frame: 1 year
(1) Clinical function: Knee joint obtained by outpatient follow-up, written questionnaires, or by telephone by trained medical professionals before surgery and 1, 3, 6, and 12 months after surgery Lysholm score, Tegner exercise ability score, and pain numeric score were used to assess the improvement of symptoms and function.Lysholm score：minimum：0，maximum：80，a higher score represents a better outcome；Tegner exercise ability score：minimum：0，maximum：80，a higher score represents a better outcome；pain numeric score：minimum：0，maximum：10，a higher score represents a worse outcome.）
1 secondary outcome
Imaging evaluation
Time frame: 1 year
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 31 Dec 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D-Printed Scaffold-Assisted PRP Combined with Autologous Periosteal-Bone Grafting and 3D Printing-Assisted Autologous Periosteal-Bone Grafting in people with Osteochondral Lesions of Knee and Osteo Arthritis, run by Second Affiliated Hospital of Nanchang University 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 5 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 31 Dec 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 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?
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?
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?
Clinical function (time frame: 1 year). 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 31 Dec 2025.