NCT07470359

Brief Summary

This prospective RCT investigates if a single 4 ml intra-articular PRP injection improves knee function after ACL reconstruction using peroneus longus autograft. In Pakistan's resource-limited context, 88 patients (18-50 years) with isolated ACL tears receive either PRP or saline during surgery, then randomized equally. KOOS4 scores compared at 3, 6, and 12 months via ANCOVA (adjusted baseline, α=0.05). Positive results could establish affordable enhancement for recovery and guide practice in similar settings.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
18mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress18%
Feb 2026Nov 2027

Study Start

First participant enrolled

February 20, 2026

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

March 10, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 13, 2026

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2027

Last Updated

March 13, 2026

Status Verified

March 1, 2026

Enrollment Period

1.5 years

First QC Date

March 10, 2026

Last Update Submit

March 10, 2026

Conditions

ACL ReconstructionIntraarticular InjectionPRP

Keywords

Anterior Cruciate Ligament, ACL Reconstruction, Peroneus Longus Autograft, Platelet-Rich Plasma, Intra-articular InjectionRandomized Controlled Trial, KOOS4 Score, Functional Outcomes, Graft Healing, Resource-Limited Settings

Outcome Measures

Primary Outcomes (1)

  • KOOS4 score

    To compare knee-related functional outcomes, as measured by the KOOS4 score, between patients undergoing arthroscopic ACL reconstruction with peroneus longus autograft and intra-articular PRP injection versus those undergoing ACL reconstruction with peroneus longus autograft alone at 3-, 6-, and 12-months post-surgery.

    12 months

Study Arms (2)

Intraarticular PRP Group

EXPERIMENTAL

Intraarticular Platelet rich plasma injection

Biological: PRP injection

Saline group

PLACEBO COMPARATOR

Normal saline group

Biological: PRP injection

Interventions

PRP injectionBIOLOGICAL

Platelets rich plasma from patients own blood

Intraarticular PRP GroupSaline group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Active individuals participating in sports or regular physical activity. Willingness to provide informed consent and adhere to the study protocol, including follow-up visits and rehabilitation.

You may not qualify if:

  • Significant chondral damage (Outerbridge grade \> 2 on pre-operative MRI or intra-operative assessment).
  • Pre-existing knee osteoarthritis (Kellgren-Lawrence grade \> 2). Systemic inflammatory conditions (e.g., rheumatoid arthritis). Bleeding disorders or coagulopathies. Current use of anticoagulants. Corticosteroid injection into the knee within 6 weeks prior to surgery. Pregnancy or lactation. Inability to comply with the rehabilitation protocol. Infection or history of infection in the affected knee. History of previous contralateral ACL injury (to isolate primary injury outcomes).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lahore General Hospital

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Related Publications (3)

  • Kunze KN, Pakanati JJ, Vadhera AS, Polce EM, Williams BT, Parvaresh KC, Chahla J. The Efficacy of Platelet-Rich Plasma for Ligament Injuries: A Systematic Review of Basic Science Literature With Protocol Quality Assessment. Orthop J Sports Med. 2022 Feb 9;10(2):23259671211066504. doi: 10.1177/23259671211066504. eCollection 2022 Feb.

    PMID: 35155701BACKGROUND

  • Gong H, Huang B, Zheng Z, Fu L, Chen L. Clinical Use of Platelet-Rich Plasma to Promote Tendon-Bone Healing and Graft Maturation in Anterior Cruciate Ligament Reconstruction-A Randomized Controlled Study. Indian J Orthop. 2022 Jan 27;56(5):805-811. doi: 10.1007/s43465-021-00533-z. eCollection 2022 May.

    PMID: 35103026BACKGROUND

  • Cao Y, Wan YD. Effectiveness of Platelet-Rich Plasma in Anterior Cruciate Ligament Reconstruction: A Systematic Review of Randomized Controlled Trials. Orthop Surg. 2022 Oct;14(10):2406-2417. doi: 10.1111/os.13279. Epub 2022 Sep 2.

    PMID: 36056588BACKGROUND

Related Links

Central Study Contacts

Hafiz Sohail Ahmad, Dr

CONTACT

+923204085069Hafiz.sohail.315@gmail.com

Abdul Subhan Zahid, Dr

CONTACT

+923104052587Abdulsubhanzahid3@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Post Graduate Resident

Study Record Dates

First Submitted

March 10, 2026

First Posted

March 13, 2026

Study Start

February 20, 2026

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

November 30, 2027

Last Updated

March 13, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)