Hinge vs CCK Implants

ConditionsRevision Arthroplasty Knee

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-80

SponsorMedstar Health Research Institute

About this trial

The primary purpose of this study is to compare reoperation rates for rotating hinge knee implants versus condylar constrained knee implants when used in revision total knee arthroplasty. The secondary purposes are to compare patient satisfaction, loosening rates and clinical outcomes for RHK implants compared to CCK implants in rTKA. Additionally, knee range of motion and stability will be assessed and compared at all follow-up time points. We hypothesize that RHK implants provide patients undergoing rTKA with similar reoperation rates to those of patients who receive a CCK implant. The investigators hypothesize that patients who receive an RHK implant will have similar loosening rates and clinical outcomes compared to patients who receive a CCK implant. Lastly, knee stability and patient satisfaction may improve with the use of a rotating hinge device.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Undergoing a revision total knee arthroplasty for any etiology

Requires revision of both tibial and femoral components

Undergoing primary total knee arthroplasty

Candidate for only rotating hinge knee implant

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

Condylar Constrained knee system. ( NexGen Legacy Condylar Constrained Knee by Zimmer Biomet)
Device
Patients in this group will receive a condylar constrained knee implant at the time of surgery and will have their outcomes with this implant assessed over 10 years.
Rotating Hinge Knee ( NexGen Rotating Hinge Knee by Zimmer Biomet)
Device
Patients in this group will receive a rotating hinge knee implant and will be followed for the next 10 years to asses outcomes.

Treatment groups

186 Participants

are divided into 2 treatment groups

Group A: Condylar Constrained KneeActive comparator 1 intervention

Group B: Rotating Hinge KneeActive comparator 1 intervention

Trial outcomes

Primary outcomes

Reoperation Rate

The primary outcome is any reoperation on the ipsilateral knee.

Time frame

From time of surgery to end of study. Investigators will plan to assess for reoperation at routine standard of care visits at the following time points: 6 weeks postoperatively, 6 months, 1 year, and then annually for 8 years

Secondary outcomes

KOOS JR score

Patient reported outcomes including KOOS JR score. It is a score that ranges from 0-100, where 0 indicates total knee disability and 100 indicates perfect knee health.

Time frame

From time of surgery to end of study. Investigators will obtain patient reported outcomes at routine standard of care visits at the following time points: preop visit and then 6 weeks postoperatively, 6 months, 1 year, and then annually for 8 years.

Aseptic Loosening

Aseptic loosening is verified through radiographic images.

Time frame

Investigators will plan to assess for Aseptic loosening at routine standard of care visits at the following time points: 6 weeks postoperatively, 6 months, 1 year, and then yearly thereafter for 8 years through radiographs

Range of motion

Range of motion at the knee joint will be assessed : flexion, extension, varus and valgus motion will be assessed.

Time frame

Investigators will plan to assess range of motion at routine standard of care clinic visits at the following time points: 6 weeks postoperatively, 6 months, 1 year, and then yearly after for 8 years

Knee society score (KSS)

Patient reported outcomes include knee society score (KSS). There is a knee score and functional score, both scored 0-100 with 0 indicating worse knee conditions and 100 indicating good knee conditions.

Time frame

From time of surgery to end of study. Investigators will plan to assess for PROMs at routine standard of care visits at the following time points: pre-op visit, 6 weeks postoperatively, 6 months, 1 year, and then annually for 8 years

Other outcomes

Any other surgical complications

The investigators plan to assess for any other surgical outcomes including but not limited to implant wear, prosthetic joint infection, periprosthetic fracture, arthrofibrosis, and instability.

Time frame

Investigators will plan to assess for complications at routine standard of care visits at the following time points: 2 weeks postoperatively, 6 weeks postoperatively, 6 months, 1 year, and then yearly after for 8 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medstar Health Research Institute

Lead sponsor

Source ClinicalTrials.gov

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