Skip to content

Comparison of Functional Outcomes Following Arthroscopic ACL Reconstruction With Peroneus Longus Autograft With and Without Intra-articular Platelet-Rich Plasma Injection.

Comparison of Functional Outcomes Following Arthroscopic ACL Reconstruction With Peroneus Longus Autograft With and Without Intra-articular Platelet-Rich Plasma Injection: A Randomized Controlled Trial

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07470359
Enrollment
60
Registered
2026-03-13
Start date
2026-02-20
Completion date
2027-11-30
Last updated
2026-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ACL Reconstruction, Intraarticular Injection, PRP

Keywords

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

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.

Detailed description

Anterior cruciate ligament (ACL) injuries impair knee function, particularly in young athletes, with many failing to regain pre-injury performance post-reconstruction (ACLR). Peroneus longus autografts offer comparable strength to traditional grafts with reduced donor site morbidity, but early recovery remains challenging. Platelet-rich plasma (PRP) may enhance graft healing, yet its efficacy with peroneus longus autografts is understudied, especially in resource-limited settings like Pakistan, where costly PRP methods are impractical. This prospective randomized controlled trial (RCT) evaluates whether a single intra-articular PRP injection (4 ml, 2 ml per femoral/tibial tunnel) improves functional outcomes in ACLR with peroneus longus autograft. The hypothesis is that PRP will lead to superior knee functions. The study aims to compare KOOS4 scores at 3, 6, and 12 months between PRP and control groups. Eighty-eight patients (44 per group) aged 18-50 with isolated ACL tears will be randomized (1:1) to receive 4 ml PRP (from 15-20 ml blood, single-spin centrifugation at 3500 rpm) or saline during surgery at Lahore General Hospital. Assessments at baseline, 3, 6, and 12 months will use validated KOOS4 questionnaires, integrated into clinic visits to ensure low dropout (10%). Data will be analyzed using analysis of covariance (ANCOVA) for KOOS4 scores (α = 0.05) in SPSS, adjusting for baseline differences. Improved KOOS4 scores with PRP could validate a cost-effective approach, enhance recovery and inform clinical guidelines in resource-constrained settings, ultimately improving patient outcomes.

Interventions

BIOLOGICALPRP injection

Platelets rich plasma from patients own blood

Sponsors

Lahore General Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

Age between 18 and 50 years. Diagnosis of a primary, complete ACL tear requiring reconstruction. Willingness to undergo arthroscopic ACL reconstruction with peroneus longus autograft. 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. Ability to understand and complete study questionnaires. -

Exclusion criteria

Previous knee surgery on the affected limb. Concomitant ligamentous injuries requiring additional reconstruction (e.g., PCL, MCL, LCL Grade III). 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). \-

Design outcomes

Primary

MeasureTime frameDescription
KOOS4 score12 monthsTo 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.

Countries

Pakistan

Contacts

CONTACTHafiz Sohail Ahmad, Dr
Hafiz.sohail.315@gmail.com+923204085069
CONTACTAbdul Subhan Zahid, Dr
Abdulsubhanzahid3@gmail.com+923104052587

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 14, 2026