Periprosthetic OsteolysisDXA-TKANCT06309433
Assessment of Periprosthetic Bone Mineral Density in Patients Undergoing Total Knee Prosthesis of Different Design
A study testing dual energy x-ray absorptiometry in people with Periprosthetic Osteolysis, run by Istituto Ortopedico Rizzoli at 2 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Periprosthetic Osteolysis
- What is being tested?
- dual energy x-ray absorptiometry
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesItaly
- Study dates
- 30 Aug 2023to Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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. -
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 2 recruiting
- Recruiting
Stefano Zaffagnini
Bologna, Italia
Stefano Zaffagnini, MD, 051 6366075, stefano.zaffagnini@unibo.it
- Recruiting
Istituto ortoepdico rizzoli
Bologna, 40136
Stefano Zaffagnini, Prof., 00390516366111, stefano.zaffagnini@unibo.it
About this study
Official 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
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.
- Conditions
- Periprosthetic Osteolysis
- Being tested
- dual energy x-ray absorptiometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dual energy x-ray absorptiometryDiagnostic test
Patient will undergo periodic (6-12-24m) dexa scans on the periprosthetic bone
| Study group | Role | What they receive |
|---|---|---|
| PS TKA | Active comparator | Patients with Posterior stabilized Total knee replacement Receives: Diagnostic Test: dual energy x-ray absorptiometry |
| CR TKA | Active comparator | Patients with cruciate retaining Total knee replacement Receives: Diagnostic Test: dual energy x-ray absorptiometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periprosthetic bone mineral density measurement
measurement of periprosthetic bone mineral density using dual-energy x-ray absorptiometry
Measured: at baseline (day 0)
Periprosthetic bone mineral density measurement
measurement of periprosthetic bone mineral density using dual-energy x-ray absorptiometry
Measured: 6 months
Periprosthetic bone mineral density measurement
measurement of periprosthetic bone mineral density using dual-energy x-ray absorptiometry
Measured: 12 months
Periprosthetic bone mineral density measurement
measurement of periprosthetic bone mineral density using dual-energy x-ray absorptiometry
Measured: 24 months
Secondary outcomes (16)
Knee Society Score
Two sections, one evaluating the patient's function and one for his clinical conditions, overall score goes from 0 to 100
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start30 Aug 2023
- Primary completionDec 2027 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periprosthetic OsteolysisStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefano Zaffagnini, Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06309433
- Sponsor's protocol ID
- DXA-TKA
- Acronym
- DXA-TKA
- Status last verified
- Mar 2026
- First submitted
- 13 Jan 2024
- Last updated
- 27 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06309433
- Acronym / sponsor ID
- DXA-TKA / DXA-TKA
- Conditions
- Periprosthetic Osteolysis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 30 Aug 2023 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 13 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PS TKA | Active comparator | Diagnostic Test: dual energy x-ray absorptiometryPatients with Posterior stabilized Total knee replacement |
| CR TKA | Active comparator | Diagnostic Test: dual energy x-ray absorptiometryPatients with cruciate retaining Total knee replacement |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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. -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dual energy x-ray absorptiometryPatient will undergo periodic (6-12-24m) dexa scans on the periprosthetic bone | Diagnostic test | CR TKA, PS TKA |
Primary outcome
Periprosthetic bone mineral density measurement
Time frame: at baseline (day 0)
measurement of periprosthetic bone mineral density using dual-energy x-ray absorptiometry
Periprosthetic bone mineral density measurement
Time frame: 6 months
measurement of periprosthetic bone mineral density using dual-energy x-ray absorptiometry
Periprosthetic bone mineral density measurement
Time frame: 12 months
measurement of periprosthetic bone mineral density using dual-energy x-ray absorptiometry
Periprosthetic bone mineral density measurement
Time frame: 24 months
measurement of periprosthetic bone mineral density using dual-energy x-ray absorptiometry
16 secondary outcomes
Knee Society Score
Time frame: at baseline (day 0)
Knee Society Score
Time frame: 6 months
Knee Society Score
Time frame: 12 months
Knee Society Score
Time frame: 24 months
Western Ontario and McMaster Universities Arthritis Index
Time frame: at baseline (day 0)
Western Ontario and McMaster Universities Arthritis Index
Time frame: 6 months
Western Ontario and McMaster Universities Arthritis Index
Time frame: 12 months
Western Ontario and McMaster Universities Arthritis Index
Time frame: 24 months
Knee injury and Osteoarthritis Outcome Score
Time frame: at baseline, (day 0)
Knee injury and Osteoarthritis Outcome Score
Time frame: 6 months
Knee injury and Osteoarthritis Outcome Score
Time frame: 12 months
Knee injury and Osteoarthritis Outcome Score
Time frame: 24 months
36-Item Short Form Health Survey
Time frame: at baseline (day 0)
36-Item Short Form Health Survey
Time frame: 6 months
36-Item Short Form Health Survey
Time frame: 12 months
36-Item Short Form Health Survey
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dual energy x-ray absorptiometry in people with Periprosthetic Osteolysis, run by Istituto Ortopedico Rizzoli at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Periprosthetic bone mineral density measurement (time frame: at baseline (day 0)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.