Knee, Revision Arthroplasty
Conditions
Keywords
CCK, Hinge, revision total knee arthroplasty
Brief summary
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.
Interventions
DEVICECondylar Constrained knee system. ( NexGen Legacy Condylar Constrained Knee by Zimmer Biomet)
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.
DEVICERotating Hinge Knee ( NexGen Rotating Hinge Knee by Zimmer Biomet)
Patients in this group will receive a rotating hinge knee implant and will be followed for the next 10 years to asses outcomes.
Sponsors
Medstar Health Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Inclusion: * Undergoing a revision total knee arthroplasty for any etiology * Requires revision of both tibial and femoral components Exclusion: * Undergoing primary total knee arthroplasty * Candidate for only rotating hinge knee implant * Diagnosed with active infection * Does not meet age criteria of \>18 or \<80 * Pregnant or breastfeeding * Unable to consent * Non-independent dweller (prisoner)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reoperation Rate | 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 | The primary outcome is any reoperation on the ipsilateral knee. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| KOOS JR score | 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. | 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. |
| Aseptic Loosening | 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 | Aseptic loosening is verified through radiographic images. |
| Range of motion | 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 | Range of motion at the knee joint will be assessed : flexion, extension, varus and valgus motion will be assessed. |
| Knee society score (KSS) | 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 | 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. |
| PROMIS score | 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. | A patient reported outcome survey assessing the patient's perspective on their overall health and quality of life. PROMIS assessments are scored on a T-score metric. High scores mean more of the concept being measured. 10 points on the T-score metric is one standard deviation (SD). PROMIS scores have a mean of 50 and standard deviation (SD) of 10 in a referent population. The referent population is usually the US General Population. A score of 40 is one SD lower than the mean of the reference population. A score of 60 is one SD higher than the mean of the reference population. Interpretation Scores 0.5 - 1.0 SD worse than the mean = mild symptoms/impairment Scores 1.0 - 2.0 SD worse than the mean = moderate symptoms/impairment Scores 2.0 SD or more worse than the mean = severe symptoms/impairment |
| UCLA Activity Score | 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. | Patient reported outcome survey which is a 10-point rating scale used to measure a patient's physical activity level. Scale ranges from 1 (wholly inactive and dependent) to 10 (regular participation in impact sports). |
| EQ5D score | 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. | Patient reported survey that assesses mobility, pain, mental health, quality of life. A total score closer to 0 indicates poor health where a score closer to 1 indicates good health. |
| SANE score | 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. | A patient reported survey is a single-question rating scale from 0 to 100 where a patient grades their current knee function as a percentage of normal with 100 indicating that their knee is completely normal. |
| Radiographic assessment of fixation | From time of surgery to end of study. Investigators will plan to assess for fixation at routine standard of care visits at the following time points: 6 weeks postoperatively, 6 months, 1 year, and then annually for 8 years. | An x-ray will be done to assess that the implant is in the correct position. |
Countries
United States
Contacts
CONTACTMiles Hollimon, B.S.
Outcome results
None listed