| CTRI Number |
CTRI/2024/04/064957 [Registered on: 01/04/2024] Trial Registered Prospectively |
| Last Modified On: |
26/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Outcomes in total knee arthroplasty using medial pivot variety of implant versus other cruciate retaining implant |
|
Scientific Title of Study
|
Comparison of clinical and radiological outcomes following total knee arthroplasty using medial pivot versus regular cruciate retaining prostheses |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Krishna Kiran Eachempati |
| Designation |
Director of Orthopaedics,Medicover Hospital |
| Affiliation |
Medicover(formerly maxcure)Hospital |
| Address |
OP block,Department of Orthopaedics,room no-3,Medicover Hospital,OPP Cyber gateway,Behind cyber Towers,near IBIS hotel,Hitech city,Hyderabad
Hyderabad
TELANGANA
500081
India |
| Phone |
9989049988 |
| Fax |
|
| Email |
kke1975@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tejas Gomase |
| Designation |
DNB Orthopedic resident |
| Affiliation |
Medicover(formerly maxcure)Hospital |
| Address |
Urban living Pg hostel, priya residency, patrika nagar, hitech city ,madhapur, hyderabad
Behind medicover hospital,
Hyderabad
Telangana - 500081
Hyderabad
TELANGANA
500081
India |
| Phone |
8668850694 |
| Fax |
|
| Email |
gomasetj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tejas Gomase |
| Designation |
DNB Orthopedic resident |
| Affiliation |
Medicover(formerly maxcure)Hospital |
| Address |
Urban living Pg hostel, priya residency, patrika nagar, hitech city ,madhapur, hyderabad
Behind medicover hospital,
Hyderabad
Telangana - 500081
Hyderabad
TELANGANA
500081
India |
| Phone |
8668850694 |
| Fax |
|
| Email |
gomasetj@gmail.com |
|
|
Source of Monetary or Material Support
|
| Medicover (formerly maxcure) Hospital,OPP Cyber gateway,Behind cyber Towers,near IBIS hotel,Hitech city,Hyderabad Hyderabad TELANGANA 500081 India |
|
|
Primary Sponsor
|
| Name |
Medicover Hospital, hitech City, Hyderabad |
| Address |
OPP cyber gateway, behind cyber towers,near Ibis hotel, madhapur, hitech City, Hyderabad |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrTejas Gomase |
Medicover (formerly maxcure) hospital ,Department of orthopaedics. |
Medicover (formerly maxcure) Hospital,OPP Cyber gateway,Behind cyber Towers,near IBIS hotel,Hitech city,Hyderabad Hyderabad TELANGANA 500081 India
Hyderabad
TELANGANA |
8668850694
gomasetj@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Medicover hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Total knee arthroplasty using medial pivot implant |
Patients selected to this arm of the study shall undergo total knee arthroplasty using a medial pivot system of implants |
| Comparator Agent |
Total knee arthroplasty using regular cruciate retaining implants |
Patients in this arm of the study shall undergo total knee arthroplasty using regular cruciate retaining systems of implants |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients who have undergone primary TKA with following Implants : medial pivot, and other cruciate retaining implants
Patients with primary osteoarthritis and varus deformity
|
|
| ExclusionCriteria |
| Details |
Patients undergoing TKA for secondary osteoarthritis.
Patients who have undergone any prior surgery to the index knee
Patients with bleeding diasthesis
Patients with pre existing neuropathies.
Inflammatory and post traumatic arthritis.
Adjoining bone and joint disease.
Patients with severe knee deformity who may require specialized implants and an increase in constraint.
Patients with other lower limb joint pathology
Patients having Hepatic failure
Patients having Renal failure
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Knee society score more than 80 |
Knee society score more than 80 at 6weeks,3months,6months and 1year post operatively. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Oxford knee score, Knee injury Osteoarthritis index score, forgotten joint society,lower extremity functional scale,Western Ontario and McMaster University Osteoarthritis index,
Hip knee ankle angle,Tibiofemoral Angle, Alpha,beta,gamma,delta angles |
Above parameters are measured at 6weeks,3months,6months,1year |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
15/04/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Osteoarthritis is a common degenerative joint disorder affecting the elderly population.The knee is the principal peripheral joint affected, resulting in progressive loss of function, pain and stiffness. Total knee arthroplasty (TKA) is a common and successful treatment for end-stage osteoarthritis. The main goals of TKA are aimed at relieving pain, improving the patient’s quality of life, and restoring function while optimizing implant longevity Most popular total knee prosthesis used are cruciate retaining and posterior stabilized. These two different TKA designs are related to two main kinematic problems of knee. The first is paradoxical motion that is an anterior translation of femoral condyles during flexion instead of physiological rollback,the second is reverse screw home that is extra rotation of tibia about 15 degrees on femur during the last 20 degrees of extension and it may cause inferior range of motion and patello femoral instability. Medial pivot variety of cruciate retaining implant mimics the natural knee kinematics and helps to overcome the above problems. Though outcomes following medial pivot TKA have been compared with TKA using posterior stabilized components in the past, there is scant literature comparing outcomes of TKA using medial pivot versus cruciate retaining prostheses. The aim of this study is to compare clinical and radiological outcomes in the patients following medial pivot cruciate retaining TKA and other cruciate retaining TKA |