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NCT Number: NCT06309433

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

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.

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Key information

Conditions

Periprosthetic Osteolysis

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stefano Zaffagnini, Bologna, Italia, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged ≥ 45 years
  • 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

  • Patients aged < 45 years;
  • 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;
  • Pregnant women. -

Treatment and study plan

Dual Energy X-ray Absorptiometry

Diagnostic Test

Patient will undergo periodic (6-12-24m) dexa scans on the periprosthetic bone

Primary outcomes

  1. Periprosthetic bone mineral density measurement

    Time frame: at baseline (day 0)

    measurement of periprosthetic bone mineral density using dual-energy x-ray absorptiometry

  2. Periprosthetic bone mineral density measurement

    Time frame: 6 months

    measurement of periprosthetic bone mineral density using dual-energy x-ray absorptiometry

  3. Periprosthetic bone mineral density measurement

    Time frame: 12 months

    measurement of periprosthetic bone mineral density using dual-energy x-ray absorptiometry

  4. Periprosthetic bone mineral density measurement

    Time frame: 24 months

    measurement of periprosthetic bone mineral density using dual-energy x-ray absorptiometry

Secondary outcomes

  1. Knee Society Score

    Time frame: at baseline (day 0)

    Two sections, one evaluating the patient's function and one for his clinical conditions, overall score goes from 0 to 100

  2. Knee Society Score

    Time frame: 6 months

    Two sections, one evaluating the patient's function and one for his clinical conditions, overall score goes from 0 to 100

  3. Knee Society Score

    Time frame: 12 months

    Two sections, one evaluating the patient's function and one for his clinical conditions, overall score goes from 0 to 100

  4. Knee Society Score

    Time frame: 24 months

    Two sections, one evaluating the patient's function and one for his clinical conditions, overall score goes from 0 to 100

  5. Western Ontario and McMaster Universities Arthritis Index

    Time frame: at baseline (day 0)

    The test evaluates main aspects of arthritis such as pain, stiffness articulation and functionality. The score goes from 0 to 96

  6. Western Ontario and McMaster Universities Arthritis Index

    Time frame: 6 months

    The test evaluates main aspects of arthritis such as pain, stiffness articulation and functionality. The score goes from 0 to 96

  7. Western Ontario and McMaster Universities Arthritis Index

    Time frame: 12 months

    The test evaluates main aspects of arthritis such as pain, stiffness articulation and functionality. The score goes from 0 to 96

  8. Western Ontario and McMaster Universities Arthritis Index

    Time frame: 24 months

    The test evaluates main aspects of arthritis such as pain, stiffness articulation and functionality. The score goes from 0 to 96

  9. Knee injury and Osteoarthritis Outcome Score

    Time frame: at baseline, (day 0)

    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

  10. Knee injury and Osteoarthritis Outcome Score

    Time frame: 6 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

  11. Knee injury and Osteoarthritis Outcome Score

    Time frame: 12 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

  12. Knee injury and Osteoarthritis Outcome Score

    Time frame: 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

  13. 36-Item Short Form Health Survey

    Time frame: at baseline (day 0)

    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.

  14. 36-Item Short Form Health Survey

    Time frame: 6 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.

  15. 36-Item Short Form Health Survey

    Time frame: 12 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.

  16. 36-Item Short Form Health Survey

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Official study title

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

Acronym: DXA-TKA

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Mar 13, 2024
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.