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Comparative study of treatment outcome in patients with anterior cruciate ligament injury undergoing reconstruction surgery with or without distal Kaplan tenodesis: a randomized clinical trial

Protocol summary

Study aim
To compare treatment outcome in patients with anterior cruciate ligament (ACL) injury undergoing reconstruction surgery with and without distal Kaplan tenodesis
Design
Two-arm parallel randomized trial, single-blind, on 60 patients, Single center
Settings and conduct
This single-center trial at Imam Khomeini Hospital (Tehran) included ACL-injury patients aged 18–45y candidates for surgery. Using block randomization (block size=4), patients were assigned to ACL reconstruction with or without Kaplan tenodesis. The surgeon was unblinded; patients, evaluator, and analyst were blinded. Follow-up included physical exams and questionnaires.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Adult patients aged 18 to 45 years, ACL injury that requires surgery. Exclusion criteria: Revision surgery of the ACL, Need for bilateral ACL reconstruction, Patients requiring simultaneous repair or reconstruction of the posterior cruciate ligament and medial or lateral collateral ligament, Patients with symptomatic articular cartilage defects requiring surgery beyond debridement and an intact lateral meniscus, Patients requiring simultaneous osteotomy
Intervention groups
Intervention group: ACL reconstruction with distal Kaplan tenodesis. After ACL reconstruction using hamstring autograft, if internal tibial rotation is observed, distal Kaplan tenodesis is performed. An incision is made in the lateral thigh, a strip is harvested from the Iliotibial Band (ITB), passed over the Lateral Collateral Ligament, and tenodesis is performed at 90 degrees of flexion. Control group: ACL reconstruction without distal Kaplan tenodesis.
Main outcome variables
amount of anterior tibial displacement, rotational stability of the knee joint, IKDC Score, Tegner Activity Scale score, Lysholm score, Pain score, need for reoperation

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200305046700N15
Registration date: 2026-07-23, 1405/05/01
Registration timing: registered_while_recruiting

Last update: 2026-07-23, 1405/05/01
Update count: 0
Registration date
2026-07-23, 1405/05/01
Registrant information
Name
Mohammadreza Razzaghof
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6658 0196
Email address
m-razzaghof@razi.tums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2025-12-22, 1404/10/01
Expected recruitment end date
2028-12-21, 1407/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of treatment outcome in patients with anterior cruciate ligament injury undergoing reconstruction surgery with or without distal Kaplan tenodesis: a randomized clinical trial
Public title
Effect of Kaplan Tenodesis on ACL Reconstruction Outcomes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Adult patients aged 18 to 55 years Anterior Cruciate Ligament (ACL) injuries that are eligible for surgery
Exclusion criteria:
Anterior Cruciate Ligament (ACL) revision surgery need for bilateral ACL reconstruction surgery patients requiring simultaneous repair or reconstruction of the posterior cruciate ligament and medial or lateral collateral ligament, patients with symptomatic articular cartilage defects requiring surgery beyond debridement, and an unhealthy lateral meniscus patients requiring simultaneous osteotomy patients whose contralateral knee is positive for any of the tests including the Anterior Drower test, Posterior Drower test, Lachman test, Pivot shift test, and rotational stability tests that raise suspicion of ligament damage
Age
From 18 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be performed using random permuted blocks with fixed size of 4. The sequence will be generated by a random number generator in Excel and placed in numbered, sealed, opaque envelopes. At the time of surgery, the next envelope will be opened by an individual independent of the surgical team, and the patient will be allocated to one of two groups (distal Kaplan tenodesis or no tenodesis) based on the code inside. Allocation concealment is ensured as those involved in recruitment, surgery, and assessment are unaware of the sequence.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, patients, the clinical evaluator, and the data analyst are blinded to the type of procedure (with or without distal Kaplan tenodesis). Only the surgeon is aware of the procedure due to the nature of the intervention. Patients are not informed before surgery and observe no difference in dressings or wound appearance post-operatively. The clinical evaluator has no access to surgical records during 3- and 9-month follow-ups, and patients are instructed not to disclose their procedure type. The data analyst remains blinded until completion of statistical analyses.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Imam Khomeini Hospital Complex/ Tehran University of Medical Sciences
Street address
Imam Khomeini Hospital Complex, East Baqerkhan Street, North Chamran Highway
City
Tehran
Province
Tehran
Postal code
1419733141
Approval date
2025-05-20, 1404/02/30
Ethics committee reference number
IR.TUMS.IKHC.REC.1404.134

Health conditions studied

1

Description of health condition studied
Anterior Cruciate Ligament Injury
ICD-10 code
S83.51
ICD-10 code description
Sprain of anterior cruciate ligament of knee

Primary outcomes

1

Description
the amount of anterior tibial displacement
Timepoint
3 months and 9 months after surgery.
Method of measurement
Lachman test

2

Description
rotational stability of the knee joint
Timepoint
3 months and 9 months after surgery.
Method of measurement
pivot shift test

3

Description
the lysholm questionnaire score
Timepoint
3 months and 9 months after surgery.
Method of measurement
Lysholm knee questionnaire

4

Description
IKDC (International Knee Documentation Committee) score
Timepoint
3 months and 9 months after surgery.
Method of measurement
International Knee Documentation Committee (IKDC) Questionnaire

5

Description
Tegner Activity Scale (TAS) score
Timepoint
3 months and 9 months after surgery.
Method of measurement
Tanger Activity Score Questionnaire

6

Description
VAS (Visual Analogue Scale) score
Timepoint
3 months and 9 months after surgery.
Method of measurement
Visual Analog Scale (VAS) questionnaire

7

Description
The exact amount of anterior tibial displacement based on the KT-1000 test grade
Timepoint
3 months and 9 months after surgery.
Method of measurement
KT1000 Arthrometer

8

Description
the need for reoperation
Timepoint
3 months and 9 months after surgery.
Method of measurement
Surgeon Evaluation and Examination

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Group undergoing Kaplan Tendonectomy after ACL reconstruction. For distal Kaplan tenodesis surgery, a 10-centimeter incision is made on the distal and lateral aspect of the thigh, at the mid-portion of the iliotibial band (ITB), with a slight inclination toward Gerdy’s tubercle. Then, a 10 × 1 centimeter strip of the ITB is incised. The proximal portion is detached, while the distal portion remains attached to the tibia at Gerdy’s tubercle.After preparing the graft, an appropriate reamer is used to create a tunnel in the femur. Finally, the graft is passed over the lateral collateral ligament (LCL), preserving the superior lateral genicular artery, and tenodesis of the graft is performed at 90 degrees of knee flexion and in a neutral rotation position.
Category
Treatment - Surgery

2

Description
Control group: Group undergoing ACL reconstruction only (Without Kaplan Tenodesis)
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
imam khomeini hospital complex
Full name of responsible person
Seyed Mohammad Javad Mortazavi
Street address
Joint Reconstruction Research Center, Imam Khomeini Hospital Complex, East Baqerkhan Street, North Chamran Highway
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 0000
Fax
+98 21 6658 1625
Email
smjmort@yahoo.com
Web page address
https://ikhc.tums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Ramin Kordi
Street address
Vice-Chancellor for Research and Technology Central Building of Tehran University of Medical Sciences, No. 226, Qods St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 8163 3686
Fax
+98 21 6658 1625
Email
ramin_kordi@tums.ac.ir
Web page address
http://vcr.tums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammadreza Razzaghof
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
No.17, Sheybani Alley, North Jamalzadeh Street
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 0196
Fax
+98 21 6658 1625
Email
m.razzaghof@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammadreza Razzaghof
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
No.17, Sheybani Alley, North Jamalzadeh Street
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 0196
Fax
Email
m-razzaghof@razi.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammadreza Razzaghof
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
No.17, Sheybani Alley, North Jamalzadeh Street
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 0196
Fax
Email
m-razzaghof@razi.tums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No decision yet
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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