Comparing two types of knee replacement surgeries
RCT Comparing Functional Outcomes for Navigated Kinematically Aligned TKR Versus Navigated Mechanically Aligned TKR
This study is testing which type of knee replacement surgery helps people move better and feel more comfortable after the operation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Hull University Teaching Hospitals NHS Trust Government |
| Drugs / interventions | radiation |
| Locations | 1 site (Hull, East Yorkshire) |
| Trial ID | NCT04246138 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the functional outcomes and range of motion (ROM) between navigated kinematically aligned total knee replacements (KA TKR) and navigated mechanically aligned total knee replacements (MA TKR). Patients will be recruited from outpatient clinics at Hull and East Yorkshire NHS Trust hospitals over a period of 18-24 months. Participants will receive detailed information about the two surgical methods and will provide informed consent before participating. The study will assess the effectiveness of each alignment technique in improving knee function post-surgery.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 90 with a diagnosis of degenerative osteoarthritis.
Not a fit: Patients with post-traumatic arthritis, significant deformities, or those with cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved functional outcomes for patients undergoing knee replacement surgery.
How similar studies have performed: Previous studies have shown varying success with different alignment techniques in knee replacement, making this a relevant investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* • Age between 18 and 90 years
* Diagnosis of degenerative osteoarthritis
Exclusion Criteria:
* o a)Post traumatic arthritis
* b)Varus /valgus deformity of more than 20 degrees
* flexion contracture of more than 20 degrees
* reduced ability to make decision like dementia patients/children
* e)if they had undergone any orthopaedic procedure to the lower limbs within the last one year
* h) neuromuscular or neurosensory deficiency
* I)inflammatory arthritis of the knee joint
* patients who suffered a complication which might influence the final outcome such as a deep infection, fracture or dysfunction of the extensor mechanism in post-operative period. However the complication rate data will be analysed and reported.
* pregnancy
* patients involved in other clinical trials within last 6 months prior to being recruited in the study
Where this trial is running
Hull, East Yorkshire
- Hull University teaching hospitals — Hull, East Yorkshire, United Kingdom (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.