| CTRI Number |
CTRI/2025/08/092790 [Registered on: 11/08/2025] Trial Registered Prospectively |
| Last Modified On: |
22/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluation of clinical and radiological outcomes in operated patients of open Latarjet surgery. |
|
Scientific Title of Study
|
To evaluate the mid-term functional and radiological outcomes of Latarjet procedure in recurrent dislocation of shoulder. |
| 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 Raj Singh |
| Designation |
Professor |
| Affiliation |
Pt B D Sharma PGIMS, Rohtak, Haryana |
| Address |
Department of Orthopaedics
Pt B D Sharma PGIMS, Rohtak, Haryana
Rohtak
HARYANA
124001
India |
| Phone |
9416216950 |
| Fax |
|
| Email |
rajpotalia@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pratik Raj |
| Designation |
Junior Resident |
| Affiliation |
Pt B D Sharma PGIMS Rohtak, Haryana |
| Address |
Research Lab, Department of Orthopaedics, Pt B D Sharma PGIMS, Rohtak, Haryana
Rohtak
HARYANA
124001
India |
| Phone |
8910082889 |
| Fax |
|
| Email |
rajpratik96@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pratik Raj |
| Designation |
Junior Resident |
| Affiliation |
Pt B D Sharma PGIMS Rohtak, Haryana |
| Address |
Research Lab, Department of Orthopaedics, Pt B D Sharma PGIMS, Rohtak, Haryana
Rohtak
HARYANA
124001
India |
| Phone |
8910082889 |
| Fax |
|
| Email |
rajpratik96@gmail.com |
|
|
Source of Monetary or Material Support
|
| Research Lab, Department of Orthopaedics, Pt B D Sharma PGIMS, Rohtak, Haryana. 124001 |
|
|
Primary Sponsor
|
| Name |
Pt B D Sharma PGIMS Rohtak |
| Address |
Department of Orthopaedics, Pt B D Sharma PGIMS Rohtak, Haryana |
| Type of Sponsor |
Government medical college |
|
|
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 Pratik Raj |
Pt B D Sharma PGIMS Rohtak |
Research Lab, Department of Orthopaedics, Pt B D Sharma PGIMS, Rohtak.
Rohtak
HARYANA |
8910082889
rajpratik96@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Committee, Pt B D Sharma PGIMS/UHS, Rohtak, Haryana |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M258||Other specified joint disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
All the patients who underwent Latarjet operation for recurrent shoulder dislocation. |
|
| ExclusionCriteria |
| Details |
Patients who are unwilling to participate in the study.
Patients who underwent an adjuvant procedure in the same limb.
Patients with rotator cuff injuries. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. Functional outcome using Oxford, ROWE and DASH scores and radiological outcomes using Computed Tomography scans. |
2 years follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
22/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
22/08/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The ideal treatment of recurrent anterior shoulder instability is still evolving. Failure of conservative management in glenohumeral instability has been found to be considerably higher in younger patients, especially in patients with high functioning demand. Non operative management in the context of bone loss in shoulder instability is reserved for high risk surgical candidates, patients with low functional demands and those with poor compliance to rehabilitation protocols. Operative management should be customized according to the patient’s intra-articular pathology and future lifestyle expectations. In recurrent instability cases, the incidence of glenoid deficiency ranges from 46 percent to 86 percent. Instability in the midranges of motion or after low energy events and daily activities of living may suggest loss of bony constraints of the glenohumeral joint such as a large glenoid or humeral head defect. It may be a significant bony defect suggested by multiple recurrences within a short timeframe or failed arthroscopic capsulo-labral reconstructions. Since soft tissue repairs in these cases are associated with an increased failure rate. This led to new inroads towards a non anatomic bony reconstruction procedure. In 1950, Latarjet et al proposed a successful technique to repair a glenoid rim defect using the coracoid process as a structural bone graft in patients suffering from recurrent shoulder instability, particularly in glenoid bone defects. This technique has been modified since the conception of extra-capsular placing of the graft through the middle part of the subscapularis tendon rather than detaching the superior one-third of the subscapularis muscle. The usage of a large coracoid bone graft to extend the glenoid articular arc, stabilizing the shoulder by means of a lengthened bone platform plus the sling effect of the conjoint tendon rather than by soft tissue alone has been promising. If a simple Bankart repair is done in the face of a significant bone deficiency, an off-axis load will be resisted only by soft tissue. On the other hand, a Latarjet reconstruction extends the glenoid articular arc so that the off-axis loads are resisted by bone as well. This obviously provides a stronger construct than a purely soft-tissue constraint. Furthermore, the capsule is reattached either through suture anchors or absorbable sutures in the native glenoid to keep the graft extra-articular. In this way, the bone graft still functions as a bony platform but does not abrade the humeral articular surface.
The advantage of the coracoid bone block transfer with conjoined tendon is explained by the triple block effect. Several studies done worldwide show that modified Latarjet procedure gives good outcomes in terms of good range of motion with stable shoulder and less complications. The modified Latarjet procedure is safe, associated with robust support to glenoid rim and provides increased resistance to anterior translation of humeral head over glenoid margin. Although it may be associated with some loss of external rotation movement, it hardly poses any hindrance to a patient’s lifestyle. In cases where the functional demand of the patient is high and recurrent shoulder dislocation has restricted his life physically, the modified Latarjet procedure presents as a potentially good option. The Latarjet procedure offers a good option for large glenoid defects. Concerns about external rotation loss and long-term arthritis still exist, though these may be minor in comparison to the reduced recurrent instability rates for this complicated patient population. |