| CTRI Number |
CTRI/2025/06/088493 [Registered on: 10/06/2025] Trial Registered Prospectively |
| Last Modified On: |
07/05/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Post Market Clinical Follow-up study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Assessment of performance, safety, and clinical outcome of Bone and Suture Anchor in the treatment of patients with foot and ankle injuries. |
|
Scientific Title of Study
|
Evaluation of clinical performance, safety, and clinical outcome of Bone and Suture Anchor in the treatment of patients with Foot & Ankle injuries. |
| 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 Shakti Swaroop |
| Designation |
Consultant Physician |
| Affiliation |
The Institute of Medical Sciences and Sum Hospital |
| Address |
The Institute of Medical science and Sum hospital,dept of Clinical research lower ground,Sum Hospital,Rd Shampur, Bhubaneswar
Khordha
ORISSA
751030
India |
| Phone |
8587904234 |
| Fax |
|
| Email |
drshaktiswaroop@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rashmi Godeshwer |
| Designation |
Deputy Manager |
| Affiliation |
Chetan Meditech Pvt. Ltd. |
| Address |
Department of Regulatory Affair
Chetan Meditech Pvt. Ltd.
MD-04, Sanand II, GIDC, Ahmedabad – 382110, Gujarat, India
Ahmadabad
GUJARAT
382110
India |
| Phone |
9727783480 |
| Fax |
|
| Email |
regulatory3@biotekortho.com |
|
Details of Contact Person
Public Query
|
| Name |
Shweta Patel |
| Designation |
Director & CEO |
| Affiliation |
Chetan Meditech Pvt. Ltd. |
| Address |
Office of Director & CEO
Chetan Meditech Pvt. Ltd.
MD-04, Sanand II, GIDC, Ahmedabad – 382110, Gujarat, India
Ahmadabad
GUJARAT
382110
India |
| Phone |
9824040213 |
| Fax |
|
| Email |
shweta@biotekortho.com |
|
|
Source of Monetary or Material Support
|
| CHETAN MEDITECH PVT.LTD.
MD-04, Sanand II, GIDC, Ahmedabad – 382110, Gujarat, India |
|
|
Primary Sponsor
|
| Name |
CHETAN MEDITECH PVT. LTD. |
| Address |
MD-04, Sanand II, GIDC, Ahmedabad – 382110, Gujarat, India |
| Type of Sponsor |
Other [Medical Device Company] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Dhimant Patel |
KD Hospital |
Vaishnodevi circle, SG Road, Ahmedabad-382421
Ahmadabad
GUJARAT |
9429125268
drdhimantortho@gmail.com |
| Dr Shakti Swaroop |
The Institute of Medical Sciences and Sum Hospital |
Department of Orthopedics, Ground Floor, Sum Hospital Road, Shampur, Bhubaneswar, Odisha-751030, India
Khordha
ORISSA |
8587904234
drshaktiswaroop@hotmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE INSTITUTE OF MEDICAL SCIENCES (IMS) AND SUM HOSPITAL |
Approved |
| KD Hospital Institutiional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Any individual with symptomatic Foot & Ankle injuries who has failed non-operative treatment and/or require repair by surgery as per the Principal Investigator’s review.
2. Male or female subject above 18 years of age at time of surgery.
3. Subject willing to comply with all the study follow-up procedures and requirements.
4. Subjects willing to give written informed consent |
|
| ExclusionCriteria |
| Details |
1. Known Hypersensitivity to the implant material.
2. Patients requiring artificial ligaments to attach in Foot & Ankle injuries.
3. Patients with 2 or more failed implantation or surgical procedures in past.
4. Acute or chronic local or systemic infection.
5. Patients with insufficient or immature bone.
6. Patients with cognitive impairment or neurologic conditions who are unwilling or incapable of following postoperative care instructions.
7. Pathological conditions of bone & soft tissue, such as osteopenia or osteoporosis.
8. Patient conditions include blood supply limitation and previous infections.
9. Active foot ulcers or venous ulcers or diabetic foot infections or chronic venous disease.
10. Comminated bone surface which hinder the fixation capacity of implant.
11. Pregnant and lactating women.
12. Subjects with uncontrolled diabetes mellitus (Hba1c above 8.5%), and or any other severe metabolic disorders that makes the subject unfit for surgical procedure.
13. Subjects with uncontrolled hypertension (DBP more than equal to 100 mm Hg and SBP more than equal to 180 mm despite receiving medication at time of enrolment.
14. Subjects with moderate to severe liver impairment and impaired renal function.
15. Subjects with history of uncontrolled epileptic seizures.
16. Subject failed to give written consent prior to enrolment.
17. Morbid obesity. (Defined as per WHO guidelines)
18. Any other ailment or disorder that is not suitable for the subject at the discretion of the investigator. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Clinical Success Rate
Clinical success is defined as foot and ankle repairs without signs of device failure and/or need of re-intervention as assessed by the surgeon. |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Clinical Success Rate |
12 months |
-Visual Analogue score (VAS)
-Foot and Ankle Outcome Score (FAOS)
-Foot and Ankle Disability Index (FADI)
-Range of Motion (ROM) |
Baseline & 2, 6, 12 months |
-All adverse events and serious adverse event occurring during surgery or post-surgery
-Type and frequency of all reported AE/SAEs/ADE/SADE or any Device Deficiency/Device malfunction |
Until study termination or study completion. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
30/06/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
The proposed, post marketing clinical follow-up study with
long-term 12 month follow-up after the fixation procedures shall provide a vital
evaluation assessment with regard to the implants- Peek and Titanium Anchor
manufactured by Chetan Meditech Pvt. Ltd., used in the surgeons’ routine
surgical procedures in foot & Ankle surgeries. Total 100 subjects will be enrolled to achieve 80 subjects
across India for indication of -Lateral Instability repair (ATFL +/- CFL repair) (lateral
ankle instability) -Medial instability repair (Medial deltoid repair) (Medial
ankle instability) -Achilles tendon repair including Haglund’s procedure
(Achilles tendon injuries) -Suture Tape augmentation (ATFL, Medial deltoid, spring
ligament (Lateral, medial and deltoid ligament injuries) The participant will undergo the relevant surgeries as
mentioned above, using the investigational device, and the study will be
assessed based on primary and secondary endpoints that includes Clinical
Success Rate, Visual Analogue Scale (VAS), Foot and Ankle Outcome Score (FAOS),
Foot and Ankle Disability Index (FADI), Range of Motion (ROM) and record of
adverse event if any.
These endpoints are used to evaluate the safety,
performance of device in real world setting |