| CTRI Number |
CTRI/2025/07/090642 [Registered on: 10/07/2025] Trial Registered Prospectively |
| Last Modified On: |
08/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
To evaluate effects of using peroneus longus tendon graft for ligament reconstruction (anterior cruciate ligament) of knee |
|
Scientific Title of Study
|
Evaluation of changes in biomechanical, clinical and functional outcome of donor ankle following ACL reconstruction with peroneus longus tendon autograft. |
| 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 Elandevan |
| Designation |
Junior Resident |
| Affiliation |
AIIMS Mangalagiri |
| Address |
Department of Orthopaedics,AIIMS Mangalagiri, Guntur,Andhra pradesh
Department of Orthopaedics,AIIMS Mangalagiri,Guntur, Andhra Pradesh
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
8667221057 |
| Fax |
|
| Email |
elandevangunasekaran@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Elandevan |
| Designation |
Junior Resident |
| Affiliation |
AIIMS Mangalagiri |
| Address |
Department of Orthopaedics,AIIMS Mangalagiri, Guntur,Andhra pradesh
Department of Orthopaedics, AIIMS Mangalagiri, Guntur, Andhra Pradesh
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
8667221057 |
| Fax |
|
| Email |
elandevangunasekaran@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vineet Thomas Abraham |
| Designation |
Additional Professor |
| Affiliation |
AIIMS Mangalagiri |
| Address |
Department of Orthopaedics, AIIMS Mangalagiri, Guntur,Andhra pradesh
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
9786912460 |
| Fax |
|
| Email |
abrahamvineet@aiimsmangalagiri.edu.in |
|
|
Source of Monetary or Material Support
|
| Department of Orthopaedics,AIIMS Mangalagiri, Guntur,Andhra pradesh - 522503, india |
|
|
Primary Sponsor
|
| Name |
Elandevan |
| Address |
Department of Orthopaedics,AIIMS Mangalagiri, Guntur,Andhra pradesh - 522503, India |
| Type of Sponsor |
Other [self] |
|
|
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 Elandevan |
Department of Orthopaedics |
Department of Orthopaedics,AIIMS Mangalagiri, Guntur,Andhra pradesh - 522503, India
Guntur
ANDHRA PRADESH |
08667221057
elandevangunasekaran@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE AIIMS MANGALAGIRI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S00-T88||Injury, poisoning and certain other consequences of external causes, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients with anterior cruciate ligament injury with or without meniscal tears who will require ACL reconstruction.
2) Patients who are above 18 years of age.
|
|
| ExclusionCriteria |
| Details |
1) Preexisting ankle injury or ankle instability.
2) Patients with osteoarthritis of ankle.
3) Patients with inflammatory arthritis like Rheumatoid arthritis, Gout
4) Patients who require revision anterior cruciate ligament reconstruction
5) Patients with multiligamentous injury of the knee |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate changes in the ankle stability of donor ankle using gait analysis and foot pressure analysis in comparison with the contralateral ankle joint.This study will assess the outcome of ankle and foot instability, knee functional outcome and donor site pain following peroneus longus autograft for ACL reconstruction. This study will shed light on whether peroneus longus autograft can be recommended as a primary graft option for ACL reconstruction.
|
outcomes will be assessed at post surgery 6 weeks, 3 momths and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To evaluate the changes in functional outcome of the foot & ankle using the AOFAS score & FADI index.
2. To evaluate changes in functional outcome of the knee using Tegner Lysholm score
3. To evaluate the pain at the donor site using the VAS score
|
outcomes will be assessed post surgery at 6 weeks, 3 months & at 6 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
01/08/2025 |
| 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="1"
Months="6"
Days="30" |
|
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
|
Patients presenting to Orthopaedics
department, All India Institute of Medical Sciences, Mangalagiri, with ACL tear
confirmed on MRI planned for ACL reconstruction will be considered for the
study. A complete history and detailed physical examination will be done.
Informed written consent will be taken before the patients are included in the
study. Patients with complete tear of the ACL confirmed by MRI findings will
then undergo ACL reconstruction using peroneus longus tendon autograft. The Patient will be assessed for
gait analysis and foot pressure parameters of bilateral ankle using DIERS
Formetric 4D dynamic gait analysis system prior to the surgery and after
surgery at 6 weeks, 3 months, 6 months. The parameters which will be studied
include Gait analysis parameters like step length, step time, stride length,
stride time, foot rotation, cadence, stance phase, load response, single
support, pressuring, swing phase and foot pressure analysis will be done. Foot
pressure analysis will be done at regular intervals to see changes in foot
pressure. Details of gait analysis and foot pressure analysis will be noted.
Patients will be evaluated preoperatively and
postoperatively at 6 weeks, 3months and 6 months interval for ankle and foot pain and the following scores will be
recorded, American Orthopaedic Foot and Ankle Society (AOFAS) Ankle and
Hindfoot scale and Foot and Ankle Disability Index (FADI). Patient’s knee pain and functional outcome will be
assessed by Tegner Lysholm score. Post surgery the patient will be evaluated
for pain at the donor site using the VAS score on day 0, 2nd day, 5th day and
14th day of surgery. |