The Use of CCK vs PS in Revision TKAs

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorRush University Medical Center

About this trial

This study aims to compare the clinical impact of Constrained Condylar versus Posterior Stabilized Knee (PS) bearings on patient satisfaction and surgical outcomes including mid-term survivorship among patients undergoing revision total knee arthroplasty.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients between 18-80 years of age

Patients who are undergoing both femoral and tibial component revisions, or isolated femoral component revisions with a retained tibial component that is compatible with PS or CCK bearings

Patients who are at least 6-weeks out from primary TKA surgery, with complete pre-operative and post-operative knee radiographs obtained at standard of care perioperative visits (AP/lateral and patellar views)

Patients undergoing rTKA for indications including aseptic component loosening, flexion or extension coronal or sagittal instability, component malalignment, arthrofibrosis, patellar maltracking, reimplantation following single or two-stage exchange revision for prosthetic joint infection or bearing surface wear when femoral or tibial component revision is indicated.

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Constrained Condylar bearing

    Device

    Patients in this intervention will receive a CCK bearing component

  • posterior stabilized bearing

    Device

    Patients in this intervention will receive a PS bearing component

Treatment groups

170 Participants
are divided into 2 treatment groups
Group A: Constrained condylar (CCK)Active comparator 1 intervention
Group B: Posterior Stabilized (PS) bearingActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Clinical patient reported outcomes

patients will be asked pre and post operatively to completed standard of care patient reported outcomes to compare over time. The clinical patient reported outcomes of a revision total knee replacement to detect a 6-point difference in knee society score (KSS)

Time frame
6 weeks post op
2

Clinical patient reported outcomes

Patients will be asked pre and post operatively to completed standard of care patient reported outcomes to compare over time. The clinical patient reported outcomes of a revision total knee replacement to detect a 6-point difference in knee society score (KSS)

Time frame
1 year post op
3

Clinical patient reported outcomes

Patients will be asked pre and post operatively to completed standard of care patient reported outcomes to compare over time. The clinical patient reported outcomes of a revision total knee replacement to detect a 6-point difference in knee society score (KSS)

Time frame
2 year post op
4

Clinical patient reported outcomes

Patients will be asked pre and post operatively to completed standard of care patient reported outcomes to compare over time. The clinical patient reported outcomes of a revision total knee replacement to detect a 6-point difference in knee society score (KSS)

Time frame
5 year post op

Secondary outcomes

1

Clinical reported outcomes (Koos Jr)

patients will be asked pre and post operatively to completed standard of care patient reported outcomes to compare over time

Time frame
6 weeks to 20 years post op
2

Range of motion over time

Patients will have their knee range of motion (ROM) checked prior to revision surgery and at multiple timepoints after surgery

Time frame
pre op to 20 years pots op
3

Clinical reported outcomes ( VR-12)

patients will be asked pre and post operatively to completed standard of care patient reported outcomes to compare over time

Time frame
6 weeks, 1 year, 2 years, 5 years, 10 years, 15 years, 20 years post op
4

Clinical reported outcomes ( Forgotten Joint Score)

patients will be asked pre and post operatively to completed standard of care patient reported outcomes to compare over time

Time frame
6 weeks to 20 years post op

Other outcomes

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