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3D-Printed Grafts for Knee Cartilage Repair

A Study on 3D Printing-assisted Platelet-rich Plasma Combined With Autologous Periosteum-bone Grafting in the Treatment of Knee Cartilage Injury

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07312175
Acronym
3D-PR-PBG
Enrollment
60
Registered
2025-12-31
Start date
2025-08-01
Completion date
2029-12-30
Last updated
2025-12-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteo Arthritis, Osteochondral Lesions of Knee

Keywords

Autologous osteoperiosteal transplantation, Massive, Osteochondral lesions, Knee

Brief 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 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.

Interventions

PROCEDURE3D-Printed Scaffold-Assisted PRP Combined with Autologous Periosteal-Bone Grafting

3D-Printed Scaffold-Assisted PRP Combined with Autologous Periosteal-Bone Grafting

PROCEDURE3D Printing-Assisted Autologous Periosteal-Bone Grafting

3D Printing-Assisted Autologous Periosteal-Bone Grafting

Sponsors

Second Affiliated Hospital of Nanchang University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

1. Age 18-65 years; 2. Body Mass Index (BMI) 18-30 kg/m²; 3. Imaging-confirmed knee cartilage damage \>2 cm² with International Cartilage Repair Society (ICRS) grade 4; 4. No significant lower limb alignment abnormalities; 5. No prior local drug injections in the knee joint within the past year.

Exclusion criteria

1. Significant osteoporosis; 2. Individuals with immature bones; 3. Those with poor mechanical alignment; 4. Presence of meniscus injury, cruciate ligament or collateral ligament rupture, or incomplete healing following surgery for any of these conditions; 5. Severe knee joint effusion; 6. Use of corticosteroids or immunosuppressive agents; 7. Poor general health, alcoholism, or substance abuse; 8. Previous treatment with autologous blood products or stem cell preparations.

Design outcomes

Primary

MeasureTime frameDescription
Clinical function1 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.)

Secondary

MeasureTime frameDescription
Imaging evaluation1 yearImaging 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026