Knee InjuriesNCT06770153
Comparison Between the Use of the Tensioner and Standard Surgical Technique for Ligament Balancing of Total Knee Prostheses
A study testing Tensor and standard in people with Knee Injuries, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
the objective of the present study is to compare the post-operative laxity using stress radiographs and clinical scores in two groups of patients undergoing primary PS TKA with identical prosthetic model performed in two specialized centers, of which one group implanted with standard technique and one group through… Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Knee Injuries
- What is being tested?
- Tensor and standard
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 11 Oct 2024to Oct 2026
- 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects candidates for primary cemented total knee prosthesis model Attune PS mobile plate DePuy.
- Patients who possess all the psychophysical capabilities to be able to undergo the operation and all the check-ups with radiological tests included (e.g. all patients who are not willing to go to the institute for all the scheduled follow-up visits will be excluded) .
- Patients who have signed the "informed consent" approved by the Ethics Committee.
- Patients who are aged between 50-85.
Who cannot join
- Social conditions that prevent participation in the study in all its phases (homeless patients, with restrictions on personal freedom, etc.)
- Patients suffering from deep venous insufficiency of the lower extremities or with a personal or family history of deep venous thrombosis or pulmonary embolism
- Patients with a history of erysipelas in the lower extremities
- Patients suffering from neurological or psycho-cognitive disorders
- Patients suffering from post-traumatic arthrosis
- Patients who have already undergone prosthetic surgery and/or arthrodesis at the level of a lower limb joint
Show all 9Show fewer
- Patients with axial knee deformities >15°
- Pregnant female patients
- Patients with rheumatic diseases
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Istituto Ortopedico Rizzoli
Bologna, 40136
Giulio Maria Marcheggiani Muccioli, MD, PhD, +39 051 6366509, marcheggianimuccioli@me.com
About this study
the objective of the present study is to compare the post-operative laxity using stress radiographs and clinical scores in two groups of patients undergoing primary PS TKA with identical prosthetic model performed in two specialized centers, of which one group implanted with standard technique and one group through the intraoperative use of the tensioner
- Conditions
- Knee Injuries
- Being tested
- Tensor, standard
- Keywords
- Knee prosthesis, prosthesis, knee
- Medical subject headings
- Knee Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TensorProcedure or surgery
balancing will be carried out using the TEMIS DePuy tensioner and carrying out any releases according to the gap-balancing technique
standardProcedure or surgery
primary TKA implantation with ligament balancing without use of the tensioner
| Study group | Role | What they receive |
|---|---|---|
| Standard | Active comparator | Not described Receives: Procedure: standard |
| Tensor | Experimental | Not described Receives: Procedure: Tensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
radiographical images
take stress x-rays (150 N) of the knee using TELOS to objectively and reproducibly analyze the lift-off (distance between the prosthetic component femoral and the tibial prosthetic component measured in mm)
Measured: at baseline, after 3 months, after 6 months anfer 12 months
Secondary outcomes (2)
Hip-Knee-Anke Angle
Hip-Knee-Anke Angle (HKA) on orthostatic panoramic radiographs of the pre- and post-operative lower limbs of the knee.
Measured: at baseline, after 3 months, after 6 months anfer 12 months
Visual Analogue Scale
Visual Analogue Scale (VAS) for pain: a scale from 0 to 10 where 0 is no pain and 10 is the worst pain ever
Measured: at baseline, after 3 months, after 6 months anfer 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start11 Oct 2024
- Primary completionAug 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee InjuriesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06770153
- Sponsor's protocol ID
- TKA-BALANCE
- Status last verified
- Jan 2026
- First submitted
- 7 Jan 2025
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between the Use of the Tensioner and Standard Surgical Technique for Ligament Balancing of Total Knee Prostheses
- ClinicalTrials.gov ID
- NCT06770153
- Acronym / sponsor ID
- TKA-BALANCE
- Conditions
- Knee Injuries
- Keywords
- Knee prosthesis, prosthesis, knee
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 11 Oct 2024 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 13 Jan 2025 (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.
the objective of the present study is to compare the post-operative laxity using stress radiographs and clinical scores in two groups of patients undergoing primary PS TKA with identical prosthetic model performed in two specialized centers, of which one group implanted with standard technique and one group through the intraoperative use of the tensioner
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard | Active comparator | Procedure: standard |
| Tensor | Experimental | Procedure: Tensor |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female subjects candidates for primary cemented total knee prosthesis model Attune PS mobile plate DePuy.
- Patients who possess all the psychophysical capabilities to be able to undergo the operation and all the check-ups with radiological tests included (e.g. all patients who are not willing to go to the institute for all the scheduled follow-up visits will be excluded) .
- Patients who have signed the "informed consent" approved by the Ethics Committee.
- Patients who are aged between 50-85.
Key exclusion criteria (9 listed)
- Social conditions that prevent participation in the study in all its phases (homeless patients, with restrictions on personal freedom, etc.)
- Patients suffering from deep venous insufficiency of the lower extremities or with a personal or family history of deep venous thrombosis or pulmonary embolism
- Patients with a history of erysipelas in the lower extremities
- Patients suffering from neurological or psycho-cognitive disorders
- Patients suffering from post-traumatic arthrosis
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 |
|---|---|---|
| Tensorbalancing will be carried out using the TEMIS DePuy tensioner and carrying out any releases according to the gap-balancing technique | Procedure or surgery | Tensor |
| standardprimary TKA implantation with ligament balancing without use of the tensioner | Procedure or surgery | Standard |
Primary outcome
radiographical images
Time frame: at baseline, after 3 months, after 6 months anfer 12 months
take stress x-rays (150 N) of the knee using TELOS to objectively and reproducibly analyze the lift-off (distance between the prosthetic component femoral and the tibial prosthetic component measured in mm)
2 secondary outcomes
Hip-Knee-Anke Angle
Time frame: at baseline, after 3 months, after 6 months anfer 12 months
Visual Analogue Scale
Time frame: at baseline, after 3 months, after 6 months anfer 12 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 26 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tensor and standard in people with Knee Injuries, run by Istituto Ortopedico Rizzoli at 1 site 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 4 inclusion and 9 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 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
radiographical images (time frame: at baseline, after 3 months, after 6 months anfer 12 months). 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 26 Jan 2026.