NCT Number: NCT07818343
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.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Not applicable
Medstar Georgetown University Hospital, Washington D.C., District of Columbia, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion:
Exclusion:
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.
Patients in this group will receive a rotating hinge knee implant and will be followed for the next 10 years to asses outcomes.
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
The primary outcome is any reoperation on the ipsilateral knee.
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.
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: 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.
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
Range of motion at the knee joint will be assessed : flexion, extension, varus and valgus motion will be assessed.
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
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 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
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.
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).
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.
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.
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.
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.
Time frame: 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.
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
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.
Contact information is provided by the study sponsor or research team.
Medstar Health Research Institute
Other
A Randomized Controlled Trial Comparing Reoperation Rates and Clinical Outcomes of Rotating Hinge Versus Condylar Constrained Knee Implants in Revision Total Knee Arthroplasty
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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