CTRI

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CTRI Number

CTRI/2026/02/103859 [Registered on: 13/02/2026] Trial Registered Prospectively

Last Modified On:

12/02/2026

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Surgical/Anesthesia

Study Design

Randomized, Parallel Group, Active Controlled Trial

Public Title of Study

Comparison of Minimal Invasive Endoscopic Surgery and Injections for Treatment of Refractory Insertional Achilles Tendinopathy

Scientific Title of Study

Comparative Assessment of Minimal Invasive Endoscopic Surgery versus Injections in Treatment of Refractory Insertional Achilles Tendinopathy (A Randomised Controlled Trial)

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 SHUBHAM RAI
Designation	JUNIOR RESIDENT
Affiliation	Uttar Pradesh University of Medical Sciences
Address	Department of Orthopaedics, UPUMS, Saifai, Etawah Etawah UTTAR PRADESH 206130 India
Phone	9455527582
Fax
Email	shubh210895@gmail.com

Details of Contact Person
Scientific Query

Name	DR SHUBHAM RAI
Designation	JUNIOR RESIDENT
Affiliation	Uttar Pradesh University of Medical Sciences
Address	Department of Orthopaedics, UPUMS, Saifai, Etawah Etawah UTTAR PRADESH 206130 India
Phone	9455527582
Fax
Email	shubh210895@gmail.com

Details of Contact Person
Public Query

Name	DR SHUBHAM RAI
Designation	JUNIOR RESIDENT
Affiliation	Uttar Pradesh University of Medical Sciences
Address	Department of Orthopaedics, UPUMS, Saifai, Etawah Etawah UTTAR PRADESH 206130 India
Phone	9455527582
Fax
Email	shubh210895@gmail.com

Source of Monetary or Material Support

NIL

Primary Sponsor

Name	UTTAR PRADESH UNIVERSITY OF MEDICAL SCIENCES
Address	UTTAR PRADESH UNIVERSITY OF MEDICAL SCIENCES, SAIFAI, ETAWAH 206130
Type of Sponsor	Government medical college

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Shubham Rai	Uttar Pradesh University of Medical Sciences	Department of Orthopaedics, Uttar Pradesh University of Medical Sciences, Saifai, Etawah Etawah UTTAR PRADESH	9455527582 shubh210895@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethical Committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: M679\|\|Unspecified disorder of synovium and tendon,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Conservative management (Injectable biologics )	Standard protocol of care
Intervention	Minimally invasive endoscopic surgery	Minimally Invasive Endoscopic Surgery for insertional Achilles Tendenopathy is usually safe and efficient with the advantage of small incision with better cosmetic scar, early weight bearing which decreases the risk of deep venous thrombosis ,less risk of achilles tendon rupture and also less wound complications.

Inclusion Criteria

Age From	18.00 Year(s)
Age To	50.00 Year(s)
Gender	Both
Details	• Symptoms for more than 3 months despite conservative management. • Patient with diagnosed degenerative Insertional Achilles Tendinopathy • Clinical diagnosed case of Refractory Insertional Achilles Tendinopathy • Unilateral and Bilateral Pain / symptoms • Patients giving written informed consent will be taken

ExclusionCriteria

Details

• Clinically diagnosed case of Non-insertional Achilles
Tendinopathy.
• Having a History of trauma or surgery to rearfoot or achilles
tendon other than procedure of interest
• Previous invasive procedures to achilles tendon such as corticosteroids injections, platelet rich plasma, or similar procedures
• Patient with systemic condition like Rheumatoid Arthritis
similar conditions affecting tendon health.
• Patient on medications affecting tendon health or healing.

Method of Generating Random Sequence

Method of Concealment

Blinding/Masking

Primary Outcome

Outcome	TimePoints
To examine and compare the patient reported outcomes, such as quality of life, satisfaction, and return to regular activities, between those who undergo Minimally invasive Endoscopic Surgery versus nonoperative treatment(Injections) for Refractory Insertional Achilles tendinopathy using VISA-A score and APQ.	To examine and compare the patient reported outcomes, such as quality of life, satisfaction, and return to regular activities, between those who undergo Minimally invasive Endoscopic Surgery versus nonoperative treatment(Injections) for Refractory Insertional Achilles tendinopathy using VISA-A score and APQ.

Secondary Outcome

Outcome	TimePoints
To study the demographic profile of Insertional Achilles Tendinopathy.
To analyze and compare the time to return to pre-injury activity levels and sports participation between patient undergoing Minimally invasive Endoscopic Surgery versus nonoperative treatment (injections) for Insertional Achilles tendinopathy.

Target Sample Size

Total Sample Size="44"
Sample Size from India="44"
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)

26/02/2026

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="0"
Months="8"
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

This thesis proposes a randomised controlled trial comparing minimally invasive endoscopic surgery with injectable conservative treatment (biologics such as PRP/GFC) in patients with refractory insertional Achilles tendinopathy. The study addresses patients who continue to have symptoms for more than three months despite standard conservative care. It will be conducted at UPUMS, Saifai, the trial will enroll 44 adults (22 surgical, 22 injection group) and follow them for up to 6 months. Outcomes will primarily be assessed using VISA-A and Achilles Pain Questionnaire (APQ) scores, along with return to activity and patient-reported satisfaction. Secondary objectives include demographic profiling and comparison of time to return to pre-injury activity levels.