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Clinical Effectiveness and Feasibility of Platelet Rich Plasma Injection in Patients with Chronic Patellar Tendinopathy

Clinical Effectiveness and Feasibility of Platelet Rich Plasma Injection in Patients with Chronic Patellar Tendinopathy - TOPPRIK

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON34982
Enrollment
20
Registered
2010-03-01
Start date
2010-03-26
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Jumper's Knee patellar tendinopathy

Interventions

PRP treatmen (PRP injection in patella tendon followed by a physical therapy program)

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • History of knee pain in the proximal section of the patellar tendon or its patellar insertion (pointed out in a anatomical drawing of the knee) in connection with training and competition • Symptoms for over twelve months (current symptoms for at least three months) • Age 18-40 years old • Palpation tenderness to the corresponding painful area • VISA score

Exclusion criteria

Exclusion criteria: • acute knee or patellar tendon injuries • chronic joint diseases • signs or symptoms of other coexisting knee pathology • pregnancy • Bleeding disorders and haematological disaeses • Malignancy • knee surgery • injection of any kind in the patellar tendon in the last preceding three months • use of NSAID*S in the last 5 days before or first 6 weeks after injection or daily use of drugs with a putative effect on patellar tendinopathy in the last year (e.g. non-steroid anti-inflammatory drugs, fluorchinolones) • actual use of anticoagulants

Design outcomes

Primary

MeasureTime frame
Part I Side effects and adverse reactions/events. Experiences of the patients. Part II Self reported VISA-P score The Dutch VISA-P score is a simple, reliable instrument for measuring the severity of patellar tendinopathy and is sensitive to small changes in symptoms. It was specifically designed for patellar tendinopathy, rating pain, symptoms, simple test of function and the ability to play sports. Six of the eight questions are scored on a VAS from 0 to 10 points, with 10 representing optimal health. The maximum VISA-P score for an asymptomatic athlete is 100 points. The VISA-P score will be obtained for both legs separately.

Secondary

MeasureTime frame
• Answer to the question: *How is your knee now as compared with before treatment?*, by marking an 11-point visual numerical scale • Rate the pain on a Visual Analogue Scale (VAS) in which 0 represents no pain, and 100 maximal pain: o during activities of daily living (ADL), o during sports, o during a functional test: the single leg decline squat (SLDS); o during a jump test: 3 jumps on both legs, 3 jumps on the best leg, 3 jumps on the affected leg. o during a triple hop test • Rate overall treatment satisfaction, with use of a 4-grade scale • Answer the question if they would recommend PRP injection treatment to family or friends; *yes* or *no*. • Ultrasound characteristics (hypo-echogenity, diameter, calcifications, neovascularisation) • Side effects and adverse reactions/events • Height and distance of the jump tests. • Number of platelets of the prepared PRP

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)