RSA Study of Persona TKA With CR vs MC Polyethylene

Not Applicable

Active, not recruiting

• Conditions: Osteoarthritis, Knee
• Interventions: Device: Medial Congruent Polyethylene (MC)

• Registration Number: NCT03494348
• Lead Sponsor: Region Skane

Brief Summary

The aim of this study is to evaluate, over a 2 year period, the migration pattern, function and the possibility of anatomical reconstruction of a relatively new total knee arthroplasty (TKA) concept, the Persona. Sixty patients will be randomized into 2 groups of 30 patients each, with one group receiving the Persona TKA with a conventional Cruciate Retaining (CR) polyethylene articular surface and the other group with a newly developed Medial Congruent (MC) articular surface. Patients will be followed up with Radiostereometry (RSA), conventional radiography, outcome questionnaires, clinical evaluation and Computer Tomography (CT). The migration pattern of the components will be evaluated as well as the degree of anatomical reconstruction and clinical result.

We plan also to do a 5 year follow-up of the patients with RSA and PROMS.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-01
• Study First Submitted: 2018-04-03
• Study First Submitted QC: 2018-04-10
• Study First Posted: 2018-04-11
• Primary Completion: 2020-10-30
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-22
• Last Update Posted: 2022-11-29
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Osteoarthritis of the knee necessitating knee replacement
• ASA I-III
• BMI 18 - 35

Exclusion Criteria

• Joint sepsis in history
• immunosuppresive drugs last 5 years
• Rheumatoid arthritis
• Severe osteoporosis or other metabolic bone diseases
• Neuromuscular diseases
• Personal disorders suspected of limiting rehab and completion of the trial period
• Previous osteotomy of affected limb
• Intra-articular knee fracture of affected limb
• Peroperative fracture
• Severe deformity of affected joint in need of augmentation or excessive release
• Obvious need for more constrained knee than CR

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Medial Congruent Polyethylene (MC)	Medial Congruent Polyethylene (MC)	The intervention here will be the MC articular surface. This is the new Polyethylene articular surface with a more congruent medial side and a more flat lateral side which should better resemble natural anatomy.

Primary Outcome Measures

Name	Time	Method
Radiostereometry (RSA)	First postoperative day, 3 months, 1 year, 2 years and 5 years	Measure the change in component migration over time (translation and rotation around the x-, y- and z-axis)

Secondary Outcome Measures

Name	Time	Method
Computer Tomography (CT)	Preoperatively and 3 months postoperatively	Measure the preoperative malalignment of the knee and the postoperatively achieved alignment and achieved prosthesis position
Conventional radiography	Preoperatively and 3 months postoperatively	Measure the preoperative malalignment of the knee and the postoperatively achieved alignment and achieved prosthesis position
General health questionnaire	Preoperatively, 1, 2 and 5 years postoperatively	EuroQol (EQ-5D) -standardized instrument for use of general health outcome
Knee specific health questionnaire	Preoperatively, 1, 2 and 5 years postoperatively	Knee disability and Osteoarthritis Outcome Score (KOOS) - this is a knee specific questionnaire measuring patients knee function and pain situation

Trial Locations

Locations (1)

Department of Orthopedics, Skane University Hospital, Lund University; 🇸🇪 Lund, Sweden