Not Yet RecruitingPhase 4ACTRN12618000762257

Can Autologous Conditioned Plasma Therapy Enhance Hamstrings Healing After Anterior Cruciate Ligament Reconstruction?

Improving Donor Site Musculotendon Regeneration following Quadrupled Semitendinosus Anterior Cruciate Ligament Reconstruction through Autologous Conditioned Plasma Therapy


Sponsor

Griffith University

Enrollment

54 participants

Start Date

Jul 3, 2023

Study Type

Interventional

Conditions

Summary

Purpose and Hypothesis: The purpose of this project is to examine whether Autologous Conditioned Plasma (ACP) therapy can enhance semitendinosus healing after Anterior Cruciate Ligament (ACL) reconstruction. Knee function and muscle-tendon regeneration will be compared 1-year post-surgery between a group receiving ACL reconstruction and a group receiving ACL reconstruction combined with Arthrex’ ACP application to the donor site. Previous studies have found donor hamstring muscles experience substantial wasting (e.g., reduce in size and strength) following ACL reconstruction. Specifically, semitendinosus and gracilis muscles and muscle-tendons experience little regeneration, retraction of the muscle belly, atrophy, strength deficits, and impairments of function. We hypothesize ACL reconstruction combined with ACP application, referred to as “ACLR+”, will result in better muscle and tendon regeneration and improved knee function at 1 year following surgery. Specifically, we hypothesize individuals receiving ACLR+ will have knee flexion strength more similar to their contralateral leg than those receiving standard ACLR. Further, we hypothesize individuals receiving ACLR+ will have muscle-tendon morphology (i.e., muscle-tendon volumes, lengths, and cross-sectional areas) similar to the muscles and tendons in the untreated contralateral leg. Conversely, those receiving standard ACL reconstruction will have a significantly smaller and lower quality donor muscle and tendons compared to the contralateral leg.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 50 Yearss

Inclusion Criteria3

  • -50 years of age undergoing primary ACLR.
  • The patient is able consent and participate fully in the intervention and follow-up testing.
  • The patient is willing to follow the rehabilitation protocol established by the treating orthopaedic surgeon and referred physiotherapists.

Exclusion Criteria9

  • Simultaneous multi-ligament repair/reconstruction.
  • Utilization of graft other than semitendinosus on affected (possible intra-operative exclusion).
  • Any revision ACLR.
  • The patient is unable to consent or participate fully in intervention and follow-up testing.
  • Any recent history of hamstring strain injuries within 6 months of ACL rupture diagnosis.
  • Pre-existing symptomatic knee osteoarthritis.
  • Medically diagnosed platelet disorder or haematological related disorder.
  • Any other medical conditions likely to interfere with testing (at discretion of recruiters).
  • Concomitant meniscus repair of lesions >1.5 cm or requiring post-operative bracing.

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Interventions

One group receives standard semitendinosus quadruple bundle Anterior Cruciate Ligament Reconstruction (ACLR), while the second group receives similar ACLR combined with Autologous Condition Plasma (AC

One group receives standard semitendinosus quadruple bundle Anterior Cruciate Ligament Reconstruction (ACLR), while the second group receives similar ACLR combined with Autologous Condition Plasma (ACP) administered to the donor site during surgery. The standard ACLR surgery group is referred to as "ACLR", whereas the group with ACLR combined with ACP is referred to as "ACLR+". For both groups, a quadruple bundle ipsilateral semitendinosus autograft is performed using an anteromedial portal technique. This is a standard surgical procedure to treat ACL deficiency and takes approximately 45 minutes. In the ACLR+ group, the surgical procedure will be augmented by application of Arthrex’ ACP therapy to the donor site and repairing the Sartorius fascia after harvest. The orthopaedic surgeon administers the ACP. For the ACP therapy, 10ml of the patient's own venous blood is aspirated and the syringe centrifuged in a proprietary closed unit (Arthrex Medical Company) for 5 minutes. The red blood cells are discarded, and the supernatant containing ACP (with additional CaCl to activate the ACP) is deposited onto the tendon excision site from pes anserinus to proximal terminus of excision. No adverse consequences are anticipated by using the ACP therapy. Following surgery, all patients will be enrolled in a standardized physiotherapy program and will continue this treatment until completion (~6-9 months clinical recommendation). In the first month, participants will attend their own physiotherapist clinic for a minimum of two one-on-one sessions per week, with each session lasting one hour. For the remaining rehabilitation, participants are required to visit their physiotherapist at least once every two weeks for one hour. During this time, participants are expected to complete their physiotherapy exercises outside of the clinic and visit the physiotherapist for re-assessment. The goal of the rehabilitation and exercises will vary depending on time after surgery. The first month of rehabilitation will involve restoring range of motion to the knee joint and strengthening of hamstring and quadriceps muscles (e.g., cycling). Months 2-3 include closed chain knee strengthening exercises (e.g., leg press) and isometric strengthening. The remaining rehabilitation will aim to restore balance through isokinetic and proprioception exercises, and eventually progress to functional movements such as running and jumping. In each phase, progression will be added by increasing resistance, increasing task complexity, and reducing stability. Adherence will be monitored for both groups through an electronic questionnaire.


Locations(2)

Pindara Private Hospital - Benowa

QLD, Australia

Robina Hospital - Robina

QLD, Australia

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ACTRN12618000762257