Assessment of Periprosthetic Bone Mineral Density in Patients Undergoing Total Knee Prosthesis of Different Design

Not Applicable

Recruiting

• Conditions: Periprosthetic Osteolysis
• Interventions: Diagnostic Test: dual energy x-ray absorptiometry

• Registration Number: NCT06309433
• Lead Sponsor: Istituto Ortopedico Rizzoli

Brief Summary

compare changes in BMD via DXA at the level of the femoral and tibial periprosthetic bone between two groups of patients undergoing cemented TKA of different design (posterior stabilization vs posterior cruciate preservation) with proms at a 2-year follow-up.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-30
• Study First Submitted: 2024-01-13
• Study First Submitted QC: 2024-03-06
• Study First Posted: 2024-03-13
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-13
• Last Update Posted: 2025-03-14
• Primary Completion: 2027-12
• Study Completion: 2028-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Patients aged ≥ 45 years
2. Patients who are candidates for primary cemented total knee replacement based on physical examination and medical history, including diagnosis of severe knee pain and disability due to at least one of the following:

to. Primary or secondary osteoarthritis b. Collagen disorders and/or avascular necrosis of the femoral condyle c. Moderate valgus, varus or flexion deformities (HKA within ±10°, flexion contracture <10°) 3. Patients consenting and able to complete planned study procedures and follow-up assessments 4. Patients informed about the nature of the study who signed the "informed consent" approved by the ethics committee.

Exclusion Criteria

1. Patients aged < 45 years;
2. Patients who have already undergone hip or knee arthroplasty ankle, previous osteotomy, with severe axial deformities or suffering from rheumatoid arthritis, diabetes or neuromuscular diseases. In this way, homogeneity of the investigated cohort will be guaranteed;
3. Pregnant women. -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PS TKA	dual energy x-ray absorptiometry	Patients with Posterior stabilized Total knee replacement
CR TKA	dual energy x-ray absorptiometry	Patients with cruciate retaining Total knee replacement

Primary Outcome Measures

Name	Time	Method
Periprosthetic bone mineral density measurement	24 months	measurement of periprosthetic bone mineral density using dual-energy x-ray absorptiometry

Secondary Outcome Measures

Name	Time	Method
Western Ontario and McMaster Universities Arthritis Index	24 months	The test evaluates main aspects of arthritis such as pain, stiffness articulation and functionality. The score goes from 0 to 96
Knee Society Score	24 months	Two sections, one evaluating the patient's function and one for his clinical conditions, overall score goes from 0 to 100
Knee injury and Osteoarthritis Outcome Score	24 months	The KOOS holds five separately scored subscales: Pain, other Symptoms, Function in daily living , Function in Sport and Recreation , and knee-related Quality of Life . the score goes from 0 to 100
36-Item Short Form Health Survey	24 months	is a valid and reliable tool for measuring health outcomes in patients with musculoskeletal pain, but its sensitivity to clinical changes in patients with specific disorders may be limited, rated on a scale of 0 to 100, with 0 and 100 being minimum and maximum possible scores.

Trial Locations

Locations (2)

Stefano Zaffagnini; 🇮🇹 Bologna, Italia, Italy

Istituto ortoepdico rizzoli; 🇮🇹 Bologna, Italy