| CTRI Number |
CTRI/2024/07/070607 [Registered on: 15/07/2024] Trial Registered Prospectively |
| Last Modified On: |
22/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective, descriptive observational study |
| Study Design |
Other |
|
Public Title of Study
|
Comparing Peroneus longus graft measurements with patients measurements in ACL reconstruction surgery |
|
Scientific Title of Study
|
Preoperative anthropometric correlation of peroneus longus graft in arthroscopic ACL reconstruction: A prospective study. |
| 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 Cyrus J Lalkaka |
| Designation |
Junior resident |
| Affiliation |
Kasturba Hospital, MAHE, Manipal |
| Address |
Department of Orthopaedics,
Kasturba Medical College, MAHE, Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
9930416319 |
| Fax |
|
| Email |
cyruslalkaka3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kiran KV Acharya |
| Designation |
Professor and Head of Department |
| Affiliation |
Kasturba Hospital, MAHE, Manipal |
| Address |
Department of Orthopaedics,
Kasturba Medical College, MAHE, Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
9481517648 |
| Fax |
|
| Email |
kiran.acharya@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Cyrus J Lalkaka |
| Designation |
Junior resident |
| Affiliation |
Kasturba Hospital, MAHE, Manipal |
| Address |
Department of Orthopaedics,
Kasturba Medical College, MAHE, Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
9930416319 |
| Fax |
|
| Email |
cyruslalkaka3@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Orthopaedics, KMC, Manipal, Tiger Circle Road, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka, India, 576104. |
|
|
Primary Sponsor
|
| Name |
Dr Cyrus J Lalkaka |
| Address |
Department of Orthopaedics, Kasturba Medical College, MAHE, Manipal, 576104 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Kiran KV Acharya |
Department of Orthopaedics, Kasturba Medical College, MAHE, Manipal, 576104 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Cyrus J Lalkaka |
Kasturba Hospital |
Department of Orthopaedics, Room No.4, Madhav Nagar, Manipal, Karnataka 576104
Udupi
KARNATAKA |
9930416319
cyruslalkaka3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 (Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M236||Other spontaneous disruption of ligament(s) of knee, |
|
|
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. Arthroscopic ACL reconstruction using Peroneus longus graft
2. Age group 18 years and above
3. ACL injuries including multi ligamentous injuries
|
|
| ExclusionCriteria |
| Details |
1. Pre-existing or associated pathology of the knee joint
2. Revision surgery
3. Previous surgeries around the knee
4. Patients on steroid or hormonal therapy
5. ACL avulsion fractures
6. Associated proximal tibia fractures
7. Deformity around the knee
8. Premature amputation of PL graft (muscle should be visible at the end of tendon after harvesting)
9. Diseases/syndromes which affect anthropometry eg. Marfans syndrome, dwarfism, gigantism, etc
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To potentially predict the peroneus longus graft dimensions using pre-operative anthropometric measurements in arthroscopic ACL reconstruction
|
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Preoperative decision for requirement of augmentation of graft |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="113"
Sample Size from India="113"
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)
|
19/07/2024 |
| 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)
Modification(s)
|
Not Applicable |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [cyruslalkaka3@gmail.com].
- For how long will this data be available start date provided 10-07-2024 and end date provided 10-07-2034?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Title of the project: Preoperative anthropometric correlation of peroneus longus graft in arthroscopic ACL reconstruction: A prospective study.
Type of Study: Single center prospective longitudinal descriptive study
Aims & objectives: AIM: To potentially predict the peroneus longus graft dimensions using pre-operative anthropometric measurements in arthroscopic ACL reconstruction OBJECTIVES: - To measure and document patient characteristics such as height, weight, BMI, leg length and calf circumference - To assess correlation between anthropometric measurements and peroneus longus graft measurements - To use preoperative anthropometric values to predict need for augmentation of graft
Departments involved: Department of Orthopaedics, Kasturba Medical College, Manipal
Study period: from July 2024 to May 2026
Sample size: 113 Calculated using Cochran’s sample size formula: n= z ² x p x (1-p) e² p=population size, e=margin of error, z=z value from z table Calculated based on the study done by Rhatomy et al [14] Using prvalance= 8%, with 95% CI, and precision level of 5%, the calculation: (1.96)² x 0.08 x (0.92)/(0.05)² = Sample size = 113
Methodology: The anthropometric measurements such as height, weight, body mass index, calf circumference and leg length (Medial joint line of knee to medial malleolus) will be preoperatively assessed. The length of peroneus longus will be measured intraoperatively immediately after harvesting. The doubled/ tripled/ quadrupled length and thickness of the peroneus longus graft will also be measured intraoperatively after preparing and tensioning the graft. The grafts will be taken by a single surgeon from the ipsilateral limb using a standard vertical supra malleolar incision at the distal end of the peroneus longus muscle and harvested in an identical fashion. The grafts will be measured intraoperatively by standard metal scales after removing muscle fibers and final trimmings of the tendon. The doubled, tripled or quadrupled graft will be passed through the Smith and Nephew sizing cylinder of 0.5mm increments till the minimum diameter that allows smooth passage of the graft which is taken as the thickness of the quadrupled graft. The femoral tunnel will be the same thickness as that of the graft. Both femoral and tibial fixation techniques will be identical in all procedures. The data will be compiled, scrutinized and evaluated to reach a conclusion regarding the relationship between peroneus longus graft dimensions and the patient’s anthropometric values. All these procedures are part of standard of care. No additional procedures have been included in the study. |