- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01765712
The Effect of Platelet Rich Plasma (PRP) on Post Operative Pain in Anterior Cruciate Ligament Reconstruction
"Effect of Intraoperative Application of Autologous PRP on Post Operative Morbidity in ACL Reconstruction Using Autologous Bone Patellar Tendon Bone Graft Harvest"
Studieoversikt
Status
Forhold
Detaljert beskrivelse
There is currently a paucity of well-designed, prospective, randomized, blinded (Level 1) clinical studies that carefully and comprehensively investigate the role of PRP in ACL surgery. Specifically, ACL reconstruction using Bone Patellar Tendon Bone (BPTB) harvest and the role of PRP in decreasing postoperative pain at the donor site. Given the need for a highly powered study to demonstrate the clinical efficacy of PRP in ACL reconstruction, the investigators have designed a prospective, randomized, level 1, double-blinded study to evaluate the effects of PRP on the specific outcomes of donor site pain and radiographic measures of graft healing and incorporation.
The aim of this study is to evaluate the efficacy of intra-operatively applied autologous PRP in reducing donor site morbidity and increasing radiographic healing in ACL reconstruction using autologous BPTB.
Studietype
Registrering (Faktiske)
Fase
- Fase 4
Kontakter og plasseringer
Studiesteder
-
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New York
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New York, New York, Forente stater, 10021
- NY Orthopedics
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Primary ACL Reconstruction
- Outerbridge </= 2
- Minimum follow up of two years
- No ligamentous secondary injury
- Willingness to participate in study
Exclusion Criteria:
- Any previous knee injury
- prior history of anterior knee pain
- Outerbridge classification 3 or greater
- Revision ACL
- Diabetic or smoker
- Workers compensation patient
- pregnant or nursing women
- Any patient with limited English Proficiency
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Placebo komparator: Control Group
Patients will be randomized into the treatment arm using a computer generated randomization table (simple randomization).
Patients in the control arm of the study will undergo Anterior cruciate ligament reconstruction using Autologous bone patellar tendon bone autograft.
At the end of the surgery, their graft donor site will have bone graft chips placed into the bony defect and the wound will be closed using sutures.
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Andre navn:
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Eksperimentell: Platelet Rich Plasma
Patients randomized into the treatment arm of the study will undergo Anterior cruciate ligament reconstruction with Autologous bone patellar tendon bone autografts.
At the start of the surgery,just after the administration of anesthesia, 10cc of blood will be withdrawn from the patients IV by the anesthesiologist.
This sample will be spun down into 3-5cc of Platelet Rich Plasma which will be added to the patients bone graft chips and placed into the donor site at the end of the case.
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Andre navn:
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Anterior Knee Pain
Tidsramme: 2 weeks, 1, 3, 6, 12, 18, 24 months. Kneeling pain for treatment groups at 24 months post-op reported.
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The primary outcome measured will be anterior knee pain.
The investigators will do so by using Visual Analog Scales as an assessment tool.
The visual analog scales will include pain with activities of daily living and pain with kneeling activities.
Information regarding these pain scales will be collected at 14 days and 1,3,6,12,18 and 24 months.
The Visual analog Scale is a score from 0-10 with 0=no pain and 10=excruciating pain.
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2 weeks, 1, 3, 6, 12, 18, 24 months. Kneeling pain for treatment groups at 24 months post-op reported.
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Radiographic Assessment of Tunnel Positioning
Tidsramme: 3 months
|
A triple view radiographic series of the knee will be performed to assess the position of the tibial and femoral tunnels by one blinded senior radiologist.
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3 months
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Quantification of Healing at the Bony and Tendinous Harvest Sites
Tidsramme: 6 months
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Post-op MRI's will be obtained to quantify the amount of bony healing at the donor site and revascularization of native patellar tendon at the harvest site.
These images will be interpreted by one blinded senior musculoskeletal radiologist.
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6 months
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Post Operative Strength
Tidsramme: 3,6,12,18,24months
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The objective clinical assessment of strength in the operative extremity will measured as quadriceps strength in a single leg hop test.
This data will be collected by an independent researcher also blinded to treatment.
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3,6,12,18,24months
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Post Operative Range of Motion
Tidsramme: 2 weeks, 1,3,6,12,18,24months
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The patients range of motion will be assessed on both the operative and non-operative knee.
This information will be assessed using a goniometer and will be collected by a blinded clinician.
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2 weeks, 1,3,6,12,18,24months
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Stephen Nicholas, MD, Northwell Health
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 12-160A
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