- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01563380
Role of Autologous Platelet Rich Plasma in Total Knee Arthroplasty (PRPTKA2012)
Efficacy of Autologous Platelet Rich Plasma on Blood Loss, Pain, Wound Healing and Functional Outcome After Total Knee Arthroplasty by a Single Surgeon A Randomized, Prospective, Controlled, Double-blinded Study
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Age, sex and BMI-matched patients who had unilateral or bilateral arthritis of the knee with similar deformity and preoperative range of motion were enrolled for this prospective randomized controlled double blinded clinical trial. The study was approved by the institutional review board, and all patients provided written informed consent to participate in it. Inclusion criteria were patient of either sex who underwent primary unilateral or bilateral surgery or the first surgery of a staged bilateral total knee replacement where the second stage was at least 6 weeks later and those who were willing and able to return for follow-up over at least a six month postoperative period. Patients with preoperative haemoglobin less than 10g/dl and with bleeding disorder were excluded from the study. Two Groups were assigned: 1) APG group and 2) Control group.
Demographic data of the patient was recorded. All routine investigations were carried out and the results were noted. Preoperative haemoglobin, range of motion, WOMAC8 scores and KSS9 scores were noted. Standard knee radiographs i.e. weight bearing anteroposterior and lateral views in 30 degree flexion were taken. Patients were randomly allocated to platelet gel group and control group using opaque envelope method which was opened on the day of surgery.
Pain was measured daily using VAS scale which consisted of markings from 1 to 10. Number of tramadol injections given was also noted. Hemoglobin was measured on the day of surgery and postop day 3 by sysmex automated analyser. Postoperative blood loss was also noted by measuring the weight of soaked dressing and converting it into blood volume. Number of blood units transfused was also recorded. Post operative wound dressing was done on day 3 except in case of soakage. Wound was assessed using wound score form. Similar physiotherapy was advised for both the groups. All the patients were advised isometric quadriceps and ankle pumping exercises on postoperative day 0 (POD0). Patients with less pain did the exercises on POD0 only. They were advocated range of motion exercises and straight leg raising on POD1. Patients with decreased pain and who were comfortable were ambulated with help of a walker on POD2. Range of motion was recorded on day 5, 6 weeks and 12 weeks and 6 months postoperatively. WOMAC scores and KSS scores were noted as shown in outcome evaluation.
Statistical analysis The statistical analysis was carried out using Statistical Package for Social Sciences (SPSS Inc., Chicago, IL, version 15.0 for Windows). All quantitative variables were estimated using measures of central location (mean, median) and measures of dispersion (standard deviation and standard error). Normality of data was checked by measures of skewness and Kolmogorov Smirnov tests of normality. For normally distributed data means were compared using student's t-test for two groups. For more than two groups ANOVA was applied. For Skewed data Mann-Whitney test was applied. Qualitative or categorical variables were described as frequencies and proportions. Proportions were compared using Chi square test. Sensitivity, specificity and diagnostic accuracy of different methods was calculated. All statistical tests were two-sided and were performed at a significance level of α=.05.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Chandigarh, Inde, 160012
- Post Graduate Institute of Medical Education & Research
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Patient of either sex who underwent primary unilateral or bilateral surgery or the first surgery of a staged bilateral total knee replacement where the second stage was at least 6 weeks later and those who were willing and able to return for follow-up over at least a six month postoperative period.
Exclusion Criteria:
- Patients with preoperative haemoglobin less than 10g/dl and with bleeding disorder were excluded from the study.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Aucune intervention: Bras de commande
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Expérimental: PRP arm
Platelet-rich plasma was applied over the wound including the capsule, medial and lateral recesses.
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PRP ready to be injected was supplied in a syringe in a quantity of 8 ml for each knee.
The entire procedure was done under complete aseptic precautions.
The calcium chloride required for activation was given in a separate syringe in a ratio of 4:1.
About 12-16 ml of platelet rich plasma was obtained by this method and it was used for application.
To confirm sterility, culture and sensitivity of PRP was performed.
Patient's peripheral blood platelet count and the prepared platelet concentrate's platelet count was performed and recorded.
Number of tramadol injections given was also noted
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Total amount of Blood loss
Délai: participants will be followed on day of surgery, post op day 3
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Hemoglobin was measured on the day of surgery and postop day3 by sysmex automated analyser.
Postoperative blood loss was also noted by measuring the weight of soaked dressing and converting it into blood volume.
Number of blood units transfused was also recorded.
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participants will be followed on day of surgery, post op day 3
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Pain
Délai: participants will be followed upto an average of 12 weeks
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Pain was measured daily using VAS scale which consisted of markings from 1 to 10.
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participants will be followed upto an average of 12 weeks
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Wound healing
Délai: Participants will be followed upto an average of 3 weeks
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Wound was assessed using wound score form.
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Participants will be followed upto an average of 3 weeks
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Range of motion
Délai: participants will be followed upto an average of 6months.
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Range of motion was recorded on day5, 6weeks and 12weeks and 6months postoperatively.
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participants will be followed upto an average of 6months.
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clinical outcome
Délai: Participants will be followed upto an average of 6months.
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Functional outcome was measured using both KSS and WOMAC scores.
We assessed the patients at 6weeks, 12weeks and 6months.
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Participants will be followed upto an average of 6months.
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Collaborateurs et enquêteurs
Les enquêteurs
- Chercheur principal: Aditya K Aggarwal, MS DNB D Ort, Post Graduate Institute of Medical Education & Research
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- adi_agg_tka_prp-2012
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