| CTRI Number |
CTRI/2026/02/103293 [Registered on: 09/02/2026] Trial Registered Prospectively |
| Last Modified On: |
06/02/2026 |
| 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
|
Study on the Safety and Performance of Bone and Suture Anchors to Treat Hand and Wrist Injuries |
|
Scientific Title of Study
|
Evaluation of Clinical Performance Safety and Clinical Outcome of Bone and Suture
Anchor in the Treatment of Patients with Hand & Wrist 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 Abhijeet Wahegaonkar |
| Designation |
Director-Hand Surgery |
| Affiliation |
SAHYADRI HOSPITAL PVT. LTD. |
| Address |
Room no 117, Hand and Wrist surgery division, Department of orthopedics surgery, Sahyadri Hospital, Plot No. 30-C, Karve Rd, Kachare Colony, Deccan Gymkhana, Pune
Pune
MAHARASHTRA
411004
India |
| Phone |
07774034263 |
| Fax |
|
| Email |
abhijeet.wahegaonkar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Akanksha Khandelwal |
| Designation |
Deputy Manager, Clinical Affairs |
| Affiliation |
Chetan Meditech Pvt. Ltd. |
| Address |
MD-04, Sanand II, GIDC
Office of Director & CEO Chetan Meditech Pvt. Ltd. MD-04, Sanand II, GIDC
Ahmadabad
GUJARAT
382110
India |
| Phone |
09727783480 |
| 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
Ahmadabad
GUJARAT
382110
India |
| Phone |
09727783480 |
| 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 |
| Type of Sponsor |
Other [Medical Device Company] |
|
|
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 Abhijeet Wahegaonkar |
SAHYADRI HOSPITAL PVT. LTD. |
Plot No. 30-C, Karve Rd, Kachare Colony, Deccan Gymkhana, Pune
Pune
MAHARASHTRA |
7774034263
abhijeet.wahegaonkar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sahyadri Hospital Private Ltd 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 |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Any individual with symptomatic hand & wrist injuries who has failed non-operative 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. Subjects 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 Hand and wrist 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 and osteoporosis.
8. Patient conditions include blood supply limitation and previous infections.
9. Active ulcers/ venous ulcers/diabetic infections/ 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 percent), and/ or any other
severe metabolic disorders that makes the Subject unfit for surgical procedure.
13. Subjects with uncontrolled hypertension (DBP greater or equal to 100 mm Hg and SBP greater or 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. Any other ailment/disorder that is not suitable for the subject at the discretion of the
investigator.
17. Subject failed to give written consent prior to enrolment.
18. Morbid obesity. (defined as per WHO guidelines)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical Success Rate (in percentage) |
06 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Clinical Success Rate |
09 & 12 Months |
| Visual Analogue Score (VAS) |
Baseline, 06, 09 & 12 Months |
| Quick - Disabilities of the arm, shoulder and hand (QDASH) |
Baseline, 06, 09 & 12 Months |
| Range of Motion (ROM- wrist and fingers) |
Baseline, 06, 09 & 12 Months |
| Pinch strength |
Baseline, 06, 09 & 12 Months |
| Grip strength |
Baseline, 06, 09 & 12 Months |
| Mayo Wrist Score |
Baseline, 06, 09 & 12 Months |
|
|
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)
|
20/02/2026 |
| 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) |
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
|
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 Anchor manufactured by Chetan Meditech Pvt. Ltd., used in the surgeons’ routine surgical procedures in hand & wrist surgeries. Total 100 subjects will be enrolled to achieve 80 subjects across India for indication of - Collateral ligament repair of hand and finger joints Volar plate/ capsular repair and reconstruction Volar repair/ reconstruction, Flexor and extensor tendon repair /reconstruction - Triangular Fibro-cartilage Complex (TFCC) repair - Scapho-lunate (SL) ligament repair - Distal radio-ulnar joint (DRUJ) repair 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), Quick- Disabilities of the arm, shoulder and hand (QDASH), Range of Motion (ROM-wrist and fingers), Pinch strength, Grip strength, Mayo Wrist Score and record of adverse event if any. |