| CTRI Number |
CTRI/2025/01/078987 [Registered on: 20/01/2025] Trial Registered Prospectively |
| Last Modified On: |
20/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Has Tendon transfer better results than Partial Rotator Cuff repair in massive irreparable Rotator cuff tears |
|
Scientific Title of Study
|
Comparison of Partial Rotator Cuff repair Versus Tendon transfers in massive irreparable Rotator cuff tears
A Randomized Control 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 PALLAV MISHRA |
| Designation |
PROFESSOR |
| Affiliation |
VMMC and SAFDARJUNG HOSPITAL |
| Address |
Room No 817, Sports Injury Centre, VMMC and Safdarjung Hospital, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9310787120 |
| Fax |
|
| Email |
DRPALLAVMISHRA1@GMAIL.COM |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr PALLAV MISHRA |
| Designation |
PROFESSOR |
| Affiliation |
VMMC and SAFDARJUNG HOSPITAL |
| Address |
Room No 817,Sports Injury Centre, VMMC and Safdarjung Hospital, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9310787120 |
| Fax |
|
| Email |
DRPALLAVMISHRA1@GMAIL.COM |
|
Details of Contact Person
Public Query
|
| Name |
Dr PALLAV MISHRA |
| Designation |
PROFESSOR |
| Affiliation |
VMMC and SAFDARJUNG HOSPITAL |
| Address |
Room No 817, Sports Injury Centre, VMMC and Safdarjung Hospital, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9310787120 |
| Fax |
|
| Email |
DRPALLAVMISHRA1@GMAIL.COM |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research |
|
|
Primary Sponsor
|
| Name |
VMMC and Safdarjung hospital |
| Address |
VMMC and Safdarjung hospital,New Delhi 110029 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Indian Council of Medical Research ICMR |
V. Ramalingaswami Bhawan P.O. Box No. 4911 Ansari Nagar New Delhi 110029 India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pallav Mishra |
VMMC and Safdarjung hospital |
Room No 817, Sports Injury Centre, VMMC and Safdarjung Hospital, New Delhi
New Delhi
DELHI |
9310787120
drpallavmishra1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, Vardhman Mahavir Medical College and Safdarjung Hospital situated at New Delhi 110029 India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: M668||Spontaneous rupture of other tendons, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Lower trapezius tendon transfer |
Duration of the intervention will be for 3 years.
Surgical technique- Lower trapezius tendon transfer Surgery will be performed in lateral decubitus position. Arthroscopic assessment of the joint and cuff tissue will be done first. Tenotomy or tenodesis of the long head of biceps will be done as per condition of the biceps tendon. Peroneus tendon/ hamstrings tendon will be harvested and will be prepared. Lower trapezius tendon will be released and mobilized. Peroneus/ hamstrings tendon will be attached to the humeral footprint using suture anchors with both free ends of the graft will be passed over infraspinatus through a window in the infraspinatus fascia. The free end of graft will be attached to the free end of mobilized trapezius tendon making a single unit. Shoulder ROM will be assessed and wound will be closed in layers. |
| Comparator Agent |
Partial rotator cuff repair |
Duration of the intervention will be for 3 years.
Surgical technique -Partial rotator cuff repair
Surgery will be performed in lateral decubitus position. Arthroscopic assessment of the joint and cuff tissue will be done first. Tenotomy or tenodesis of the long head of biceps will be done as per condition of the biceps tendon. Cuff tissue will be mobilized by intra and extra articular releases of the cuff tissue. Even after the release if cuff does not restore upto it’s humeral footprint, margin convergence, medialisation of the cuff attachment using suture anchors will be attempted. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Age 40-70 years
Patients with shoulder pain & weakness in abduction & external rotation
Patients with massive irreparable rotator cuff tears (Goutalliers stage 3 or more, retraction up to glenoid )
|
|
| ExclusionCriteria |
| Details |
Patients who are not fit to undergo a surgical procedure under General Anaesthesia
Patients with advanced Glenohumeral arthritis (KL scale 3 or beyond).
Patients with restriction of passive ROM
Patients with other associated pathologies of shoulder joint.
Patients with previous shoulder surgery
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary outcome will be assessed through shoulder ROM, VAS score, constant murley score, strength |
preoperatively and at 3 months, 6 months , 1 year and 2 years after the surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary outcome will be measured in terms of any patient reported outcome & complications & reoperations rates |
At 3 months, 6 months, 1 year & 2 years |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
31/01/2025 |
| 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="3"
Months="0"
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
|
Massive Irreparable cuff tears are challenge to treatment. Even with multiple treatment options present , there is no procedure of choice defined for these tears. Partial cuff repair and tendon transfer surgeries provide a near anatomical repair when compared to the alternatives. This RCT aims to provide high quality evidence on the comparative effectiveness of Partial Rotator Cuff repair Vs Tendon transfers in massive irreparable Rotator cuff tears, informing treatment decisions and improving patient outcome
|