Validation of a New Technique for the Evaluation of the Patello-femoral Joint Kinematics (CINE-FEMORO)

• ClinicalTrials.gov Identifier: NCT03448198
• Recruitment Status: Completed
• First Posted: February 28, 2018
• Last Update Posted: February 28, 2018
• Sponsor: Istituto Ortopedico Rizzoli
• Information provided by (Responsible Party): Claudio Belvedere, Istituto Ortopedico Rizzoli

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Knee Osteoarthritis	Procedure: Total knee replacement	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Masking Description: open label
• Primary Purpose: Treatment
• Official Title: Validation of a New Technique for the Evaluation of the Patello-femoral Joint Kinematics
• Actual Study Start Date: November 16, 2012
• Actual Primary Completion Date: May 16, 2014
• Actual Study Completion Date: November 16, 2014

Arms and Interventions

Arm	Intervention/treatment
Knee arthritis; Total knee replacement	Procedure: Total knee replacement; Primary knee gonarthrosis treated with navigated total knee replacement and computer-assisted patellar replacement.

Outcome Measures

Primary Outcome Measures :

1. Knee prosthesis rotational alignment [ Time Frame: At time of surgery ]
   Rotational (in deg) positioning of femur, tibia and patella prosthesis components.
2. Knee prosthesis translational alignment [ Time Frame: At time of surgery ]
   Translational (in mm) positioning of femur, tibia and patella prosthesis components.

Secondary Outcome Measures :

1. Intra-operative knee joint rotations [ Time Frame: At time of surgery ]
   Assessed rotations (in deg): tibio-femoral flexion-extension, ad-abduction and internal-external rotation; patello-femoral flexion-extension, medio-lateral rotation and tilt.
2. Intra-operative knee joint translations [ Time Frame: At time of surgery ]
   Assessed translations (in mm): tibio-femoral and patello-femoral anterio-posterior, medial-lateral and proximal-distal translations.
3. Post-operative knee joint rotations [ Time Frame: 24 months ]
   Assessed rotations (in deg): tibio-femoral flexion-extension, ad-abduction and internal-external rotation; patello-femoral flexion-extension, medio-lateral rotation and tilt.
4. Post-operative knee joint translations [ Time Frame: 24 months ]
   Assessed translations (in mm): tibio-femoral and patello-femoral anterio-posterior, medial-lateral and proximal-distal translations.

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Patients with unilateral primary knee arthrosis indicated for total knee replacement.
• Patients able to understand the protocol and to sign the informed consent.

Exclusion Criteria:

• Patients with indications for revision surgery.
• Patients with patellectomy.
• Child-bearing female.

Contacts and Locations

Locations

Italy

Istituto Ortopedico Rizzoli

Bologna, Italy, 40136

Sponsors and Collaborators

Istituto Ortopedico Rizzoli

Investigators

• Principal Investigator: Andrea Ensini, MD; Istituto Ortopedico Rizzoli

  Study Documents (Full-Text)

Documents provided by Claudio Belvedere, Istituto Ortopedico Rizzoli:

Study Protocol, Statistical Analysis Plan, and Informed Consent Form  [PDF] November 16, 2012

More Information

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. Review.

Sparmann 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.

Belvedere 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. Epub 2007 Apr 13.

Burnett 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.

Fantozzi 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.

• Responsible Party: Claudio Belvedere, PhD, Istituto Ortopedico Rizzoli
• ClinicalTrials.gov Identifier: NCT03448198
• Other Study ID Numbers: 39521/2012
• First Posted: February 28, 2018
• Last Update Posted: February 28, 2018
• Last Verified: February 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Claudio Belvedere, Istituto Ortopedico Rizzoli:

total knee arthroplasty; patellar resurfacing; patellar tracking; patello-femoral joint kinematics; surgical navigation; computer-aided surgery

Additional relevant MeSH terms:

Osteoarthritis; Osteoarthritis, Knee; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases