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Clinical Trials/CTRI/2024/09/073758
CTRI/2024/09/073758CompletedPhase 4

Comparison of Functional Outcome of Central Soft Tissue Quadriceps Tendon Graft versus Quadrupled Hamstring Tendon Graft for Arthroscopic Anterior Cruciate Ligament Reconstruction- A Prospective Randomized Control Trial

Aswin S1 site in 1 country68 target enrollmentStarted: September 17, 2024Last updated:

Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Enrollment
68
Locations
1
Primary Endpoint
To compare Functional outcomes in ACL Reconstruction using, 1. Lysholm knee score

Study Overview

Brief Summary

Consent will be obtained from eligible participants of this study based on the above mentioned inclusion and exclusion criteria. Demographic information, anthropometric measurements will be collected from all participants. Blood investigations will be done for all participants. Intra operative obtained graft measurements will be recorded. Post operatively all patients of both the group will be following the standardized same ACL protocol physiotherapy . Post operatively patient of the both groups will be followed up at specified interval mentioned above and functional outcome measurements will be recorded.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Patient with Isolated Anterior cruciate ligament tear.

Exclusion Criteria

  • Multi-ligamentous injury
  • Revision Anterior Cruciate Ligament Reconstruction surgery
  • Associated Ipsilateral Limb Fractures where Anterior Cruciate Ligament Reconstruction planned.

Outcomes

Primary Outcomes

To compare Functional outcomes in ACL Reconstruction using, 1. Lysholm knee score

Time Frame: Post Surgical intervention followed up at 1st month, 3rd month, 5th month, Return to preinjury level ( at which specified month)

2. IKDC-SKF( International Knee Documentation Committee - Subjective Knee Evaluation Form) SCORE

Time Frame: Post Surgical intervention followed up at 1st month, 3rd month, 5th month, Return to preinjury level ( at which specified month)

3.Tegner activity scale

Time Frame: Post Surgical intervention followed up at 1st month, 3rd month, 5th month, Return to preinjury level ( at which specified month)

4. ACL-RSI ( Anterior Cruciate Ligament-Return to Sport after Injury) Score

Time Frame: Post Surgical intervention followed up at 1st month, 3rd month, 5th month, Return to preinjury level ( at which specified month)

5. Passive Knee Range of Movements

Time Frame: Post Surgical intervention followed up at 1st month, 3rd month, 5th month, Return to preinjury level ( at which specified month)

Secondary Outcomes

  • To assess these factors post operatively(1. VAS Score)

Investigators

Sponsor
Aswin S
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Aswin S

SRM Medical College Hospital and Research Centre

Study Sites (1)

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