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NCT06122727
Comparison of Custom and Standard Total Knee Replacements
NA trial testing total knee arthroplasty in Knee Osteoarthritis in 20 participants. Currently enrolling.
30 December 2025
Quick facts
| Lead sponsor | Istituto Ortopedico Rizzoli |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 1 March 2023 |
| Primary completion | 30 December 2025 |
| Estimated completion | 30 April 2026 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- total knee arthroplasty — full drug profile →
Conditions studied
- Knee Osteoarthritis — all drugs for Knee Osteoarthritis →
Sponsor
Istituto Ortopedico Rizzoli — full company profile →
Who can join
Adults 40 to 70, any sex, with Knee Osteoarthritis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Total knee arthroplasty (TKA) is the most common surgery in North America and the second most common in Europe. One of the most critical issues for stability and durability of the interventional is the prosthesis-bone geometric fit, where a required a perfect match; the recent availability of custom 3D implants can overcome this problem. In order to further improve a TKA surgery, it is in fact, it is possible today to completely customize the procedure for each individual patient, with cost and time now accessible. This intervention can be performed with the use of instrumentation specific to the patient (so-called resin 'cutting templates' referred to as PSI, "Patient Specific Instrumentation") to make cuts accurate bone cuts in accordance with a specific 3D preoperative plan . Also the design and fabrication in of the components prosthetic components themselves, in metal and polyethylene, is done by means of 3D printing. Based on the unique anatomy of each patient, the precise sagittal orientation and axial rotation of the components of the prosthesis customized for the surgeon, it is possible to plan and perform the surgery quickly and in accordance with the exact specifications of the individual patient. These procedures should also make it possible to greatly reduce the instrumentation and the sizes that need to be available in the operating room, reducing time and costs associated with transportation and storage . The objective of this study is to compare primary TKAs performed with a customized procedure (prostheses customized for each patient based on his or her reconstructed knee morphology by tomographic scans, and implanted via cutting guides customized for the patient) with standard primary TKAs, considering: the objective radiological results, the subjective results of the patients and the costs of both procedures.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06122727
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of total knee arthroplasty
Trials testing the same drug.
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- NCT05833152 — Correlation Between Preoperative Knee Extension Lag and Functional Outcome After Total Knee Arthroplasty · completed
- NCT05477745 — The Correlation Between Femoral Component Implanting Flexion Angle and Posterior Condyle Offset in Cruciate Retaining To · unknown
- NCT05429671 — Antibiotic Loaded Cement After TKA · Phase 3 · completed
- NCT07515378 — Three Dimensional Gait Analysis After Total Knee Arthroplasty - Comparison of Objective and Patient-reported Outcomes Be · NA · completed
Other recruiting trials for Knee Osteoarthritis
Currently open trials in the same condition.
- NCT06906939 — A Randomized Pilot rTMS Trial for Knee Arthritis Pain and Depression · EARLY_PHASE1 · recruiting
- NCT05823727 — Effects of Collagen Peptide Supplementation on Connective Tissue Remodeling, Functional Outcomes, and Wound Healing Afte · NA · recruiting
- NCT07370480 — Knee Osteoarthritis and Thermal Spa Treatment · NA · recruiting
- NCT07507175 — Gastrocnemius Myofascial Release in Females With Knee Osteoarthritis · NA · recruiting
- NCT07386600 — Dexamethasone vs Dexmedetomidine for iPACK + ACB in TKA · NA · recruiting
Other Istituto Ortopedico Rizzoli trials
Trials by the same sponsor.
- NCT07590882 — Evaluation of Return to Sports Activity After Periacetabular Osteotomy: An Observational Study · enrolling by invitation
- NCT07021222 — Multifactorial Strategies for the Prevention of the Risks of Ulceration in Patients Affected by Diabetic Foot (DARE-DiaF · NA · recruiting
- NCT07360964 — Clear Cell Chondrosarcoma in Italy · NA · active not recruiting
- NCT07140367 — "Transarterial Microembolization (TAME) in Inflammatory Knee Pathology" · recruiting
- NCT07102875 — Ready to Sail 2: A Pilot Study of Sail-Assisted Telerehabilitation in Rare Skeletal Diseases · NA · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06122727 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Istituto Ortopedico Rizzoli
- Last refreshed: 30 July 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06122727.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing