Assessment of Periprosthetic Bone Mineral Density in Patients Undergoing Total Knee Prosthesis of Different Design (DXA-TKA)

Assessment of Bone Mineral Density at the Interface With the Femoral and Tibial Components in Patients Undergoing Total Knee Prosthesis of Different Design and Material

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.

Study Overview

• Status: Recruiting
• Conditions: Periprosthetic Osteolysis
• Intervention / Treatment: Diagnostic test: dual energy x-ray absorptiometry

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Bologna, Italy, 40136
    • Recruiting
    • Istituto ortoepdico rizzoli
    • Contact: Stefano Zaffagnini, Prof.; Phone Number: 00390516366111; Email: stefano.zaffagnini@unibo.it
  • Italia
    • Bologna, Italia, Italy
      • Recruiting
      • Stefano Zaffagnini
      • Contact: Stefano Zaffagnini, MD; Phone Number: 051 6366075; Email: stefano.zaffagnini@unibo.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PS TKA; Patients with Posterior stabilized Total knee replacement	Diagnostic test: dual energy x-ray absorptiometry; Patient will undergo periodic (6-12-24m) dexa scans on the periprosthetic bone
Active Comparator: CR TKA; Patients with cruciate retaining Total knee replacement	Diagnostic test: dual energy x-ray absorptiometry; Patient will undergo periodic (6-12-24m) dexa scans on the periprosthetic bone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Periprosthetic bone mineral density measurement	measurement of periprosthetic bone mineral density using dual-energy x-ray absorptiometry	at baseline (day 0)
Periprosthetic bone mineral density measurement	measurement of periprosthetic bone mineral density using dual-energy x-ray absorptiometry	6 months
Periprosthetic bone mineral density measurement	measurement of periprosthetic bone mineral density using dual-energy x-ray absorptiometry	12 months
Periprosthetic bone mineral density measurement	measurement of periprosthetic bone mineral density using dual-energy x-ray absorptiometry	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee Society Score	Two sections, one evaluating the patient's function and one for his clinical conditions, overall score goes from 0 to 100	at baseline (day 0)
Knee Society Score	Two sections, one evaluating the patient's function and one for his clinical conditions, overall score goes from 0 to 100	6 months
Knee Society Score	Two sections, one evaluating the patient's function and one for his clinical conditions, overall score goes from 0 to 100	12 months
Knee Society Score	Two sections, one evaluating the patient's function and one for his clinical conditions, overall score goes from 0 to 100	24 months
Western Ontario and McMaster Universities Arthritis Index	The test evaluates main aspects of arthritis such as pain, stiffness articulation and functionality. The score goes from 0 to 96	at baseline (day 0)
Western Ontario and McMaster Universities Arthritis Index	The test evaluates main aspects of arthritis such as pain, stiffness articulation and functionality. The score goes from 0 to 96	6 months
Western Ontario and McMaster Universities Arthritis Index	The test evaluates main aspects of arthritis such as pain, stiffness articulation and functionality. The score goes from 0 to 96	12 months
Western Ontario and McMaster Universities Arthritis Index	The test evaluates main aspects of arthritis such as pain, stiffness articulation and functionality. The score goes from 0 to 96	24 months
Knee injury and Osteoarthritis Outcome Score	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	at baseline, (day 0)
Knee injury and Osteoarthritis Outcome Score	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	6 months
Knee injury and Osteoarthritis Outcome Score	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	12 months
Knee injury and Osteoarthritis Outcome Score	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	24 months
36-Item Short Form Health Survey	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.	at baseline (day 0)
36-Item Short Form Health Survey	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.	6 months
36-Item Short Form Health Survey	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.	12 months
36-Item Short Form Health Survey	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.	24 months

Collaborators and Investigators

• Sponsor: Istituto Ortopedico Rizzoli

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: January 13, 2024
• First Submitted That Met QC Criteria: March 6, 2024
• First Posted (Actual): March 13, 2024

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 6, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases; Bone Resorption; Osteolysis
• Other Study ID Numbers: DXA-TKA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No