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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03676179
Other study ID # 08/2561
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2018
Est. completion date April 1, 2019

Study information

Verified date March 2019
Source Ramathibodi Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

the present study will conduct to assess anterior knee pain and complications after medial UKA with or without patella denervation in medial compartment arthritis and severe lateral facet patellofemoral arthritis patients.


Description:

In this prospective cohort study, the investigators will conduct to compare the clinical result of 70 patients of unicompartment knee arthroplasty with and without patella denervation between April, 2018 and April, 2019 for the patients with osteoarthritis.


Recruitment information / eligibility

Status Completed
Enrollment 66
Est. completion date April 1, 2019
Est. primary completion date April 1, 2019
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility Inclusion Criteria:

- Patients who diagnose with medial osteoarthritis (OA) of the knee with an Alhback score of 2, 3 and 4 (Ahlback 1968) and with any Kujala score for pre-operative anterior knee pain.

- Older than 40 years of age.

- pain on the medial joint line.

- primary medial compartment osteoarthritis with a well preserved lateral compartment with competent cruciate ligaments with correctable intraarticular varus deformity.

- ROM flexion up to 110° under anesthesia.

Exclusion Criteria:

- Patients with fixed varus deformity > 15°

- Inflammatory arthritis

- Previous high tibial osteotomy or ACL reconstruction

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
patella denervation
patella denervation
patella non-denervation
patella non-denervation

Locations

Country Name City State
Thailand Pranungkraw General Hospital Bangkok

Sponsors (2)

Lead Sponsor Collaborator
Ramathibodi Hospital Pranungkraw General Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary Kujala score Kujala score including 13 parameters with the score of 0-100, the higher the score the better the function. 6 months
Secondary complication number of participant with DVT, infections, loosening of implants, fractures, lateral compartment arthritis, and dislocations of the polyethylene 6 months
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