Own blood product injection into joint and in bone in Osteoarthritis Knee

Not yet recruiting

Conditions: Bilateral primary osteoarthritis of knee,

Registration Number: CTRI/2019/04/018613

Lead Sponsor: All India Institute of Medical Sciences Bhubaneswar

Brief Summary: Osteoarthritis (OA) Knee is a common debilitating condition, for which there is no cure. Although OA is not a life-threatening condition, the severity of this disease lies in the continuous pain and functional impairment.

It is evident from the literature, that cartilage loss is not only a pathologic process that triggers OA. Subchondral bone is identified as the starting place for pathologic changes, and cartilage is the victim of this process. In OA, the sub-chondral bone undergoes changes which include microcrack, structural defects and progressive replacement of the subchondral marrow with fibro neurovascular mesenchymal tissue. Hence, lesions in this subchondral tissue lead inevitably to the onset of OA, if they are not treated properly.

The popular biologic therapy, autologous platelet rich plasma (PRP), prepared from patients own blood, contains a pool of growth factors for cartilage repair. Biological analysis of PRP has also demonstrated an anti-inflammatory effect on the intra-articular environment. The use of platelet-rich plasma (PRP) for the treatment of osteoarthritis (OA) has demonstrated mixed clinical outcomes in randomized controlled trials.

As it is yet to establish which of the joint tissues, among synovial membranes, synovial fluid, articular cartilage or sub-chondral bones, is the primary driver of OA Knee, it is not clear whether we should target one or multiple tissues or structures during interventions. We can assume that targeting several joint tissues or structures at a time, can provide a better result.

Hence, we are planning to conduct this study to see whether the addition of intra-osseous injections of PRP directly into the subchondral bone to conventional intra-articular treatment would achieve a better positive effect in OA Knee.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 50

Inclusion Criteria

1.Patients aged 40-65 years, who are able to walk with a painful knee and fulfilled the criteria for knee OA of the medial femorotibial joint, as defined by the American College of Rheumatology (ACR).
2.Persisting Knee Pain due to OA Knee (Grade II/III, according to the radiological classification of knee OA defined by Kellgren and Lawrence) 3.Pain of at least 20 mm on a 0-100mm VAS when asked: â€œhow painful is your knee during level walking?â€ 4.If both knees involved, participants choose one or both knees to be treated.
5.Willing to participate in all assessment.

Exclusion Criteria

1)Severe OA Knee (Grade IV, according to Kellgren and Lawrence classification) 2)Haemoglobin level < 10gm% 3)Inflammatory or post-infectious knee arthritis 4)History of prior knee replacement repair 5)Prior fracture of the knee joint 6)Any Knee injection within 3 months 7)Daily use of opioid medication 8)Coexisting Backache, other chronic pain disorder 9)Body mass index (BMI) greater than 40 kg/m2 10)Blood disorders, hematological, cardiac, hepatic or renal disorders.
11)Patients who had received either an oral, topical or intra-articular steroid during the four weeks before the study pregnancy 12)Co-morbidity severe enough to prevent participation in the study protocol including at-home exercise or attendance at scheduled injection appointments.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Visual analogue pain Score (0-10cm)	0 month (V1), 1.5 months (V2), 3 months (V3)

Secondary Outcome Measures

Name	Time	Method
KOOS questionnaire (0-100)	Range of motion of affected knee joint

Trial Locations

Locations (1): PMR OPD
🇮🇳
Khordha, ORISSA, India
PMR OPD
🇮🇳Khordha, ORISSA, India
Dr Apurba Barman
Principal investigator
09438884211
apurvaa23@gmail.com