| CTRI Number |
CTRI/2025/10/095737 [Registered on: 08/10/2025] Trial Registered Prospectively |
| Last Modified On: |
06/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Repair of Achilles Tendon Rupture without open surgery |
|
Scientific Title of Study
|
Prospective Study on Percutaneous Repair of Closed Achilles Tendon Rupture Using an IV
Cannula: A Novel Approach |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Raju Karuppal |
| Designation |
Professor |
| Affiliation |
Govt. Medical College Kozhikode |
| Address |
Dr.Raju Karuppal, Professor Department of Orthopaedics,
2nd floor, NMCH Govt. Medical College Kozhikode,
Kozhikode
KERALA
673008
India
Rhythm, Vidyanagar colony, Chevayur post, PIN 673017
Kozhikode
KERALA
673008
India |
| Phone |
9447330002 |
| Fax |
|
| Email |
drrajuortho@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Raju Karuppal |
| Designation |
Professor |
| Affiliation |
Govt. Medical College Kozhikode |
| Address |
Dr.Raju Karuppal, Professor Department of Orthopaedics,
2nd floor, NMCH Govt. Medical College Kozhikode,
Kozhikode
KERALA
673008
India
Rhythm, Vidyanagar colony, Chevayur post, PIN 673017
Kozhikode
KERALA
673008
India |
| Phone |
9447330002 |
| Fax |
|
| Email |
drrajuortho@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Raju Karuppal |
| Designation |
Professor |
| Affiliation |
Govt. Medical College Kozhikode |
| Address |
Dr.Raju Karuppal, Professor Department of Orthopaedics,
2nd floor, NMCH Govt. Medical College Kozhikode,
Kozhikode
KERALA
673008
India
Rhythm, Vidyanagar colony, Chevayur post, PIN 673017
Kozhikode
KERALA
673008
India |
| Phone |
9447330002 |
| Fax |
|
| Email |
drrajuortho@rediffmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Government Medical College Kozhikode |
| Address |
Government Medical College Kozhikode, Medical College PO PIN
673008, KERALA, INDIA |
| 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 |
| Raju Karuppal |
Government medical college Kozhikode , Kerala |
Department of orthopaedics , Room no-114,
First floor , OP Building
Medical college post
PIN 673008, Kozhikode district
Kozhikode
KERALA |
9447330002
drrajuortho@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE GOVERNMENT MEDICAL COLLEGE KOZHIKODE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, (2) ICD-10 Condition: M65-M67||Disorders of synovium and tendon, (3) ICD-10 Condition: M66||Spontaneous rupture of synovium and tendon, (4) ICD-10 Condition: M663||Spontaneous rupture of flexor tendons, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NOT APPLICABLE |
No comparator
Single arm study |
| Intervention |
Percutaneous Repair of Closed Achilles Tendon Ruptures Using an IV Cannula |
The patient will be positioned prone. Skin preparation will be performed in the usual fashion and a sterile field is prepped for about 10 cm proximal and distal to the palpable tendon defect. Procedure can be performed under spinal anaesthesia .
A 5mm stab incision is made over the medial side of the palpable defect of AT using a size 11 scalpel blade. Medial side is selected to avoid the iatrogenic injury to the sural nerve. The first 16G IV cannula is pierced from the lateral side of AT about 2cms above the AT defect and passes through the substance of AT to come out through the 5mm stab wound. Then the single strand of PDS thread is passed from the medial side( bevelled end of cannula) to lateral side through the IV cannula . Now the first cannula has to be kept in the same position. Then the second 16G IV cannula has to be introduced about 4 cms above the defect on the medial side towards lateral side in a oblique route to come out through the puncture site of the first IV cannula.This is to avoid the tagging of deep fascia or skin between the thread. Now the first IV cannula can be withdrawn and the PDS thread can be passed through the bevelled end of second IV cannula to come out on medial side. The same steps are repeated towards proximally for two more times( 8 cms above the defect approximately). Then start to come distally by passing the same PDS thread through the IV cannula distally in the form of Bunnel’s configuration. Then pass the PDS threads through the distal segment of ruptured AT in similar fashion.
Most often we will be able to take maximum two/ three bites on the short distal AT segment. And finally the PDS thread has to come out through the 5 mm stab wound. Now the ankle joint is kept in maximum equinous position and make multiple knots of the PDS thread. Make sure that a perfect end to end apposition of AT has obtained before final tightening. Majority of cases this Bunnel’s suturing configuration would be adequate. If there is any thoughts to give more stability, a short segment Bunnel’s suturing can be added over to it. Skin closure is not required for a small stab wound of 5mm. A below knee plaster cast should be given with foot in 10 degrees of equinous for three weeks followed by an AFO splint with ankle in neutral position for three more weeks. Post operative rehabilitation can be started immediately.. Non weight bearing walking on crutches can be permitted from same day followed by partial weight bearing from six weeks onwards. Full weight bearing may be recommended only after 8 weeks from the day of surgery. Isometric and ROM exercises of ankle joint can be started after the plaster cast removal at the end of third week.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Acutely injury of less than 14 days
|
|
| ExclusionCriteria |
| Details |
(i) treatment with steroid drugs;
(ii) rupture at the musculotendinous junction;
(iii) rupture at the calcaneal insertion;
(iv) open rupture; and
(v) re-rupture. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the efficacy of the new percutaneous AT repair through 16G cannula.
|
To assess the efficacy of the new percutaneous AT repair through 16G cannula.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.To assess the post operative functional outcome |
2 years 6 months |
| 2.To evaluate the complications |
2 years 6 months |
|
|
Target Sample Size
|
Total Sample Size="89"
Sample Size from India="89"
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)
|
20/10/2025 |
| 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="2"
Months="6"
Days="15" |
|
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 who will be attending the department of orthopaedics with closed rapture of Achilles tendon diagnosed clinically and confirmed by USG will be included They will be treated by the novel percutaneous repair technique through 16 G IV cannula After the procedure patients will be followed up after 2 weeks to inspect the surgical site They will be reviewed at 3 months six months and one year At each follow-up visits functional outcome will be assessed using American Orthopedic Foot & Ankle Society (AOFAS) score and the ArnerLindholm scale Complications like surgical site infection, sensory deficit of Sural nerve, ankle joint movements will also be assessed.
|