| CTRI Number |
CTRI/2024/10/075096 [Registered on: 10/10/2024] Trial Registered Prospectively |
| Last Modified On: |
01/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Other |
|
Public Title of Study
|
To study the clinical efficacy and improvement in blood and synovial fluid in patients suffering from grade 2-3 Knee OA with minimal or no coronal plane deformity treated with Knee Distraction without use of external fixators |
|
Scientific Title of Study
|
Prospective single-arm study to assess the performance and safety of an internal joint distraction device for the treatment of adult patients with knee Osteoarthritis |
| 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 Sachin Tapasvi |
| Designation |
Consultant Orthopedic Surgeon |
| Affiliation |
Sahyadri Super Speciality Hospital |
| Address |
Sahyadri Super Speciality Hospital,Orthopedic Surgery Department,
5th Floor, Consultation room
30C, Erandwane, Karve Road 411004
Pune
MAHARASHTRA
411004
India |
| Phone |
9822018871 |
| Fax |
|
| Email |
stapasvi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sachin Tapasvi |
| Designation |
Consultant Orthopedic Surgeon |
| Affiliation |
Sahyadri Super Speciality Hospital |
| Address |
Sahyadri Super Speciality Hospital,Orthopedic Surgery Department,
5th Floor, Consultation room
30C, Erandwane, Karve Road 411004
Pune
MAHARASHTRA
411004
India |
| Phone |
9822018871 |
| Fax |
|
| Email |
stapasvi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sachin Tapasvi |
| Designation |
Consultant Orthopedic Surgeon |
| Affiliation |
Sahyadri Super Speciality Hospital |
| Address |
Sahyadri Super Speciality Hospital,Orthopedic Surgery Department,
5th Floor, Consultation room
30C, Erandwane, Karve Road 411004
Pune
MAHARASHTRA
411004
India |
| Phone |
9822018871 |
| Fax |
|
| Email |
stapasvi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tapasvi Charitable and Medical Center, 1268, Shukrawar Peth, Lane 6, Subashnagar, Pune-411002, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Dr Sachin Tapasvi |
| Address |
Tapasvi Charitable and Medical Center,
1268, Shukrawar Peth,
Lane 6, Subhashnagar,
Pune 411002
Maharashtra, India |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Dr Sachin Tapasvi |
Sahyadri Super Speciality Hospital |
Sahyadri Super Speciality Hospital,Orthopedic Surgery Department,
5th Floor, Consultation room
30C, Erandwane, Karve Road 411004
Pune
MAHARASHTRA |
9822018871
stapasvi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sahyadri Hospitals Private Limited Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Knee Distraction Device
Commercial brand name: not available |
The Knee Distraction Device is an internal fixation device, with plates implanted in contact with the femur and tibia, and screws fixing them to the bones. The device is intended to maintain the articulation in a distracted position during a period of six weeks. There are two shapes (straight and curved) for the tibial plate and two sizes (size 1 and size 2) for the femoral plate.
IIb (rule 8: implantable devices, not included in the exemptions listed in rule 8) according to the Regulation (EU) 2017/745 on medical devices. |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
95.00 Year(s) |
| Gender |
Both |
| Details |
Adults ≤65 years old eligible for a surgery of the knee
Male and female patients suffering from tibiofemoral OA Kellgren Lawrence grade II, III, or IV
Painful knee despite conservative treatments like physiotherapy, infiltration, well-managed medical treatment more than 6 months).Pain more than 40 mm in VAS at D0
For women Non menopausal with the same reliable contraception since at least 3 cycles before the beginning of the study and agreeing to keep it until the end of the study
Good general and mental health within the opinion of the investigator: no clinically significant and relevant abnormalities of medical history or physical examination
Able and willing to participate in the study by complying with the protocol procedures as evidenced by his dated and signed informed consent form |
|
| ExclusionCriteria |
| Details |
Epiphyseal deformity no frontal deformation greater than MPTA 83;91°, mLDFA 84;91° and total bone deformity more than 5°, sagittal deformation PPTS more than 12°
Patient with more than 5° of extension deficit
Pregnant or breastfeeding women
BMI more than 35
Bone diseases that may interfere with proper screws fixation
Acute or chronic local or systemic infections
Allergy to one of the materials used or sensitivity to foreign bodies
Uncontrolled diabetes HbA1C more than 7.5
Painful patellofemoral OA
Patient with significant pain disorders other than tibiofemoral OA
Taking corticosteroids within the past 3 months
Injection of hyaluronic acid, corticosteroids, or other treatment on the treated joint in the last six months prior to enrollment
BW more than 120 kg
Large medial osteophytes that may interfere with plate positioning |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain with the KOOS sub-score of pain at D270 (9 months) comparatively to baseline |
at baseline and 9 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pain with the KOOS subscore of pain at D135 i.e. 4.5 months compared to baseline. |
D135 i.e. 4.5 months |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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
|
N/A |
|
Date of First Enrollment (India)
|
30/10/2024 |
| 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="2"
Months="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
KJD
is a joint-preserving treatment for patients under 65 suffering from KOA, where
the knee joint is temporarily fully unloaded by the distraction of the tibia
and the femur with an external fixator over several weeks. This approach
reduces mechanical constraints on the joint by spreading out the arthritic
joint surfaces (damaged cartilage). It induces a cascade of molecular signals
(growth factors, cytokines, etc.) that stimulate the biological process of
cartilage reconstruction (chondrogenesis). Good clinical results include
long-term pain reduction, improvement in functional scores with non-inferiority
criteria at two years compared to total knee arthroplasty (TKA), cartilage
regrowth, and delayed TKA. However, KJD is associated with patient discomfort
and a high rate of peri-operative infection due to external fixators.The KDD aims to scientifically validate
this new joint distraction approach without external fixators via the use of a
subcutaneous implant to
deliver results in terms of patient pain relief and assess the safety of the
device. Therefore, this clinical study aims to reproduce the distraction
procedure described in the literature using the same joint surface spreading
principle and intra-articular kinematics. Theoretically, this approach minimises
the impact of the procedure on the patient, with better recovery and less
impact in the postoperative period.
|