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Clinical Trials/NCT01812564
NCT01812564
Completed
Phase 2

Clinical Utilization of Growth Factors Preparations in the Management of Acute Hamstring Muscle Strain Injury

Aspetar1 site in 1 country90 target enrollmentNovember 2009
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ConditionsAcute Hamstring Muscle Strain Injury

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Acute Hamstring Muscle Strain Injury
Sponsor
Aspetar
Enrollment
90
Locations
1
Primary Endpoint
Time to Return to Play
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the therapeutic benefit of utilizing complex growth factor preparations (Platelet Rich Plasma (PRP) in the management of acute hamstring injuries.

The hypothesis is that the time to return to sport is shorter in the patient group treated with Complex Growth Factor Preparations (PRP) in combination with exercise therapy in comparison with 2 control groups:

  • the patient group treated with Platelet Poor Plasma (PPP) injections in combination with exercise therapy (control injection AND usual care).
  • the patient group treated with exercise therapy (usual care)
Registry
clinicaltrials.gov
Start Date
November 2009
End Date
October 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Sponsor
Aspetar
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Acute onset posterior thigh pain
  • •MRI confirmed Grade I, II hamstring lesions
  • •\< 5 days from injury
  • •Able to perform Physiotherapy at ASPETAR (5 sessions/week)
  • •Available for follow-up
  • •Age \> 18 years

Exclusion Criteria

  • •Diabetes, immuno-compromised state
  • •Overlying skin infection
  • •Re-injury or Chronic ongoing hamstring injury
  • •Unwilling to comply with follow up
  • •Contraindication to MRI
  • •Needle Phobia
  • •Bleeding disorder or other medical contraindication to injection
  • •Medication increasing bleeding risk (e.g. Plavix)
  • •Concurrent other injury inhibiting rehabilitation

Outcomes

Primary Outcomes

Time to Return to Play

Time Frame: Patients will be followed for the duration of time to return to play with an expected average of 27 days and up to 1 year.

Time to return to full sports activity; either training or match play.

Secondary Outcomes

  • Recurrent hamstring lesions.(2 months after return to play, 1 year after return to play.)

Study Sites (1)

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