Knee OsteoarthritisCINE-FEMORONCT03448198
Validation of a New Technique for the Evaluation of the Patello-femoral Joint Kinematics
A study testing Total knee replacement in people with Knee Osteoarthritis, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
The objective of this study is to validate a new technique for intraoperative quantification of the patello-femoral joint kinematics in patients undergoing total knee replacement, and for postoperative quantification of implanted knee and general lower limb activity, along with relevant muscle dynamics. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Total knee replacement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 16 Nov 2012to 16 Nov 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with unilateral primary knee arthrosis indicated for total knee replacement.
- Patients able to understand the protocol and to sign the informed consent.
Who cannot join
- Patients with indications for revision surgery.
- Patients with patellectomy.
- Child-bearing female.
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to validate a new technique for intraoperative quantification of the patello-femoral joint kinematics in patients undergoing total knee replacement, and for postoperative quantification of implanted knee and general lower limb activity, along with relevant muscle dynamics.
Read the detailed description
In total knee replacement with patellar resurfacing, the patellar bone preparation and relevant component positioning, including relevant motion assessments, are still not navigated, and only femoral/tibial component positioning is supported by computer-assistance. After surgery, anterior knee pain is generally reported and this may due to prosthesis component mal-positioning, including the patella, and, ultimately, this may result in revision arthroplasty. Within computer-assisted surgery, surgical navigated system have been introduced to monitor femur and tibia prosthesis implantation and to assess tibio-femoral joint kinematics. In this context, the patella is still disregarded or limitedly considered, whereas it is still debated if the patella should be resurfaced in total knee replacement. Recently, new navigation-based procedures have been tested to allow the intra-operative monitoring of patellar-based data for more proper patellar resurfacing; at follow-up under active conditions, video-fluoroscopy, so far used to assess general tibio-femoral kinematics, offers the potentials for patellar motion tracking.
The possibility in vivo to perform intra-operative evaluations of the patello-femoral joint data, i.e. including patellar bone morphology and motion, via computer assisted procedures during surgery would allow the surgeon to have a more complete comprehension of the knee functioning in patients undergoing total knee replacement; these procedures, along with derived data, can act as a support in for the most critical surgical actions in terms of femoral/tibial prosthesis component implantation and related patellar resurfacing. Furthermore, at post-operative follow-ups via fluoroscopic acquisitions and gait analysis, it is possible to evaluate how the implant is able to recover, or not, the normative physiological motion at both tibio-femoral and patello-femoral joint.
The goal of this study is to validate a new technique for intra-operative quantification of the patello-femoral joint kinematics in patients undergoing total knee replacement, and for postoperative quantification of implanted knee and general lower limb activity, along with relevant muscle dynamics.
- Conditions
- Knee Osteoarthritis
- Being tested
- Total knee replacement
- Keywords
- total knee arthroplasty, patellar resurfacing, patellar tracking, patello-femoral joint kinematics, surgical navigation, computer-aided surgery
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total knee replacementProcedure or surgery
Primary knee gonarthrosis treated with navigated total knee replacement and computer-assisted patellar replacement.
| Study group | Role | What they receive |
|---|---|---|
| Knee arthritis | Other | Total knee replacement Receives: Procedure: Total knee replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee prosthesis rotational alignment
Rotational (in deg) positioning of femur, tibia and patella prosthesis components.
Measured: At time of surgery
Knee prosthesis translational alignment
Translational (in mm) positioning of femur, tibia and patella prosthesis components.
Measured: At time of surgery
Secondary outcomes (4)
Intra-operative knee joint rotations
Assessed rotations (in deg): tibio-femoral flexion-extension, ad-abduction and internal-external rotation; patello-femoral flexion-extension, medio-lateral rotation and tilt.
Measured: At time of surgery
Intra-operative knee joint translations
Assessed translations (in mm): tibio-femoral and patello-femoral anterio-posterior, medial-lateral and proximal-distal translations.
Measured: At time of surgery
Post-operative knee joint rotations
Assessed rotations (in deg): tibio-femoral flexion-extension, ad-abduction and internal-external rotation; patello-femoral flexion-extension, medio-lateral rotation and tilt.
Measured: 24 months
Post-operative knee joint translations
Assessed translations (in mm): tibio-femoral and patello-femoral anterio-posterior, medial-lateral and proximal-distal translations.
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 posted28 Feb 2018
- Study start16 Nov 2012
- Primary completion16 May 2014
- Study completion16 Nov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudio Belvedere, Istituto Ortopedico Rizzoli
- Investigators
- Andrea Ensini, MD, Principal investigator, Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03448198
- Sponsor's protocol ID
- 39521/2012
- Acronym
- CINE-FEMORO
- Status last verified
- Feb 2018
- First submitted
- 9 Feb 2018
- Last updated
- 28 Feb 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cutbill JW, Ladly KO, Bray RC, Thorne P, Verhoef M. Anterior knee pain: a review. Clin J Sport Med. 1997 Jan;7(1):40-5. doi: 10.1097/00042752-199701000-00008.
PubMed 9117525Sparmann M, Wolke B, Czupalla H, Banzer D, Zink A. Positioning of total knee arthroplasty with and without navigation support. A prospective, randomised study. J Bone Joint Surg Br. 2003 Aug;85(6):830-5.
PubMed 12931800Belvedere C, Catani F, Ensini A, Moctezuma de la Barrera JL, Leardini A. Patellar tracking during total knee arthroplasty: an in vitro feasibility study. Knee Surg Sports Traumatol Arthrosc. 2007 Aug;15(8):985-93. doi: 10.1007/s00167-007-0320-1. Epub 2007 Apr 13.
PubMed 17431587Burnett RS, Haydon CM, Rorabeck CH, Bourne RB. Patella resurfacing versus nonresurfacing in total knee arthroplasty: results of a randomized controlled clinical trial at a minimum of 10 years' followup. Clin Orthop Relat Res. 2004 Nov;(428):12-25.
PubMed 15534514Fantozzi S, Benedetti MG, Leardini A, Banks SA, Cappello A, Assirelli D, Catani F. Fluoroscopic and gait analysis of the functional performance in stair ascent of two total knee replacement designs. Gait Posture. 2003 Jun;17(3):225-34. doi: 10.1016/s0966-6362(02)00096-6.
PubMed 12770636
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a New Technique for the Evaluation of the Patello-femoral Joint Kinematics
- ClinicalTrials.gov ID
- NCT03448198
- Acronym / sponsor ID
- CINE-FEMORO / 39521/2012
- Conditions
- Knee Osteoarthritis
- Keywords
- total knee arthroplasty, patellar resurfacing, patellar tracking, patello-femoral joint kinematics, surgical navigation, computer-aided surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 16 Nov 2012 (actual)
- Primary completion
- 16 May 2014 (actual)
- Study completion
- 16 Nov 2014 (actual)
- First posted
- 28 Feb 2018 (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 this study is to validate a new technique for intraoperative quantification of the patello-femoral joint kinematics in patients undergoing total knee replacement, and for postoperative quantification of implanted knee and general lower limb activity, along with relevant muscle dynamics.
Detailed description
In total knee replacement with patellar resurfacing, the patellar bone preparation and relevant component positioning, including relevant motion assessments, are still not navigated, and only femoral/tibial component positioning is supported by computer-assistance. After surgery, anterior knee pain is generally reported and this may due to prosthesis component mal-positioning, including the patella, and, ultimately, this may result in revision arthroplasty. Within computer-assisted surgery, surgical navigated system have been introduced to monitor femur and tibia prosthesis implantation and to assess tibio-femoral joint kinematics. In this context, the patella is still disregarded or limitedly considered, whereas it is still debated if the patella should be resurfaced in total knee replacement. Recently, new navigation-based procedures have been tested to allow the intra-operative monitoring of patellar-based data for more proper patellar resurfacing; at follow-up under active conditions, video-fluoroscopy, so far used to assess general tibio-femoral kinematics, offers the potentials for patellar motion tracking.
The possibility in vivo to perform intra-operative evaluations of the patello-femoral joint data, i.e. including patellar bone morphology and motion, via computer assisted procedures during surgery would allow the surgeon to have a more complete comprehension of the knee functioning in patients undergoing total knee replacement; these procedures, along with derived data, can act as a support in for the most critical surgical actions in terms of femoral/tibial prosthesis component implantation and related patellar resurfacing. Furthermore, at post-operative follow-ups via fluoroscopic acquisitions and gait analysis, it is possible to evaluate how the implant is able to recover, or not, the normative physiological motion at both tibio-femoral and patello-femoral joint.
The goal of this study is to validate a new technique for intra-operative quantification of the patello-femoral joint kinematics in patients undergoing total knee replacement, and for postoperative quantification of implanted knee and general lower limb activity, along with relevant muscle dynamics.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Knee arthritis | Other | Procedure: Total knee replacementTotal knee replacement |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with unilateral primary knee arthrosis indicated for total knee replacement.
- Patients able to understand the protocol and to sign the informed consent.
Key exclusion criteria (3 listed)
- Patients with indications for revision surgery.
- Patients with patellectomy.
- Child-bearing female.
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 |
|---|---|---|
| Total knee replacementPrimary knee gonarthrosis treated with navigated total knee replacement and computer-assisted patellar replacement. | Procedure or surgery | Knee arthritis |
Primary outcome
Knee prosthesis rotational alignment
Time frame: At time of surgery
Rotational (in deg) positioning of femur, tibia and patella prosthesis components.
Knee prosthesis translational alignment
Time frame: At time of surgery
Translational (in mm) positioning of femur, tibia and patella prosthesis components.
4 secondary outcomes
Intra-operative knee joint rotations
Time frame: At time of surgery
Intra-operative knee joint translations
Time frame: At time of surgery
Post-operative knee joint rotations
Time frame: 24 months
Post-operative knee joint translations
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2018.
- Background: PubMed 9117525Cutbill JW, Ladly KO, Bray RC, Thorne P, Verhoef M. Anterior knee pain: a review. Clin J Sport Med. 1997 Jan;7(1):40-5. doi: 10.1097/00042752-199701000-00008.
- Background: PubMed 12931800Sparmann M, Wolke B, Czupalla H, Banzer D, Zink A. Positioning of total knee arthroplasty with and without navigation support. A prospective, randomised study. J Bone Joint Surg Br. 2003 Aug;85(6):830-5.
- Background: PubMed 17431587Belvedere C, Catani F, Ensini A, Moctezuma de la Barrera JL, Leardini A. Patellar tracking during total knee arthroplasty: an in vitro feasibility study. Knee Surg Sports Traumatol Arthrosc. 2007 Aug;15(8):985-93. doi: 10.1007/s00167-007-0320-1. Epub 2007 Apr 13.
- Background: PubMed 15534514Burnett RS, Haydon CM, Rorabeck CH, Bourne RB. Patella resurfacing versus nonresurfacing in total knee arthroplasty: results of a randomized controlled clinical trial at a minimum of 10 years' followup. Clin Orthop Relat Res. 2004 Nov;(428):12-25.
- Background: PubMed 12770636Fantozzi S, Benedetti MG, Leardini A, Banks SA, Cappello A, Assirelli D, Catani F. Fluoroscopic and gait analysis of the functional performance in stair ascent of two total knee replacement designs. Gait Posture. 2003 Jun;17(3):225-34. doi: 10.1016/s0966-6362(02)00096-6.
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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. This study is not recruiting at the moment.
Andrea Ensini, MD principal investigator
Istituto Ortopedico Rizzoli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total knee replacement in people with Knee Osteoarthritis, 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 2 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: finished, as of the sponsor's last update on 28 Feb 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee prosthesis rotational alignment (time frame: At time of surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03448198, which also lists 5 linked publications.
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 28 Feb 2018.