Recruiting PHASE2 Anterior Cruciate Ligament Injuries

New treatment option for Anterior Cruciate Ligament Injuries

Official title Vitamin D to Improve Quadricep Muscle Strength

ClinicalTrials.gov ID: NCT05174611

What this study is testing

What it's testing
Quadriceps muscle strength is one of the key determinants for patients to fulfill the Return-to-Play (RTP) criteria after an anterior cruciate ligament reconstruction (ACLR), in which the muscle size is directly linked to muscle strength. Quadriceps muscle atrophy is unavoidable after ACLR, but the rehabilitation program should increase quadriceps muscle mass.
  • Phase 2: a mid-size study of how well it works
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 40

You may be able to join if

  • Aged 18-40 with unilateral ACL injury
  • Sporting injury with a Tegner score of 7
  • Pre-op serum vitamin D level \<20 ng/ml
  • 4 months post-ACLR with serum Vitamin D level remained \<20ng/ml
  • LSI for quadriceps strength \<70% of contralateral leg at 4-month isokinetic assessment

You likely can't join if

  • Concomitant bone fracture, major meniscus injury or full-thickness chondral injuries requiring altered rehabilitation program post-operatively
  • Pre-operative radiographic signs of arthritis
  • Metal implants that would cause interference on MRI
  • Non-HS graft for ACLR
  • Patient non-compliant to the rehabilitation program
  • Regular sunbed users
See the full eligibility criteria
Who can join
  • Aged 18-40 with unilateral ACL injury
  • Sporting injury with a Tegner score of 7
  • Pre-op serum vitamin D level \<20 ng/ml
  • 4 months post-ACLR with serum Vitamin D level remained \<20ng/ml
  • LSI for quadriceps strength \<70% of contralateral leg at 4-month isokinetic assessment
  • Both knees without history of injury/prior surgery
What rules you out
  • Concomitant bone fracture, major meniscus injury or full-thickness chondral injuries requiring altered rehabilitation program post-operatively
  • Pre-operative radiographic signs of arthritis
  • Metal implants that would cause interference on MRI
  • Non-HS graft for ACLR
  • Patient non-compliant to the rehabilitation program
  • Regular sunbed users

The study team makes the final eligibility decision.

Where it's taking place

  • Hong Kong, Hong Kong

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years to 40 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Hong Kong, Hong Kong. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.