3D-Printed Grafts for Knee Cartilage Repair

NCT07312175 | Active Not Recruiting

• 1 other identifier: I-2025126
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteochondral Lesions of Knee; Osteo Arthritis

Keywords

Autologous osteoperiosteal transplantation; Massive; Osteochondral lesions; Knee

Outcome Measures

Primary Outcomes (1)

• 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.）

  1 year

Secondary Outcomes (1)

• Imaging evaluation

  1 year

Study Arms (2)

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

EXPERIMENTAL

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

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

Procedure: 3D-Printed Scaffold-Assisted PRP Combined with Autologous Periosteal-Bone Grafting; Procedure: 3D Printing-Assisted Autologous Periosteal-Bone Grafting

Interventions

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

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

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

3D Printing-Assisted Autologous Periosteal-Bone Grafting PROCEDURE

3D Printing-Assisted Autologous Periosteal-Bone Grafting

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital of Nanchang University: lead

Study Sites (1)

330006

Nanchang, Jiangxi, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: December 31, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): December 30, 2029
• Study Completion (Estimated): December 30, 2029
• Last Updated: December 31, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)