Study of Platelet-rich Plasma in Treating Patients With Tibiofemoral Cartilage Degeneration
This study has been completed.
Sponsor:
Komzak Martin, M.D.
Information provided by (Responsible Party):
Komzak Martin, M.D., Hospital Znojmo
ClinicalTrials.gov Identifier:
NCT01418755
First received: August 15, 2011
Last updated: September 14, 2011
Last verified: September 2011
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Purpose
Recently an articular cartilage repair has been given much attention in the orthopaedic field. Cartilage regeneration capacity is very limited. Optimal approach seems to be a delivery of natural growth factors. Autologous platelet-rich plasma (PRP) contains proliferative and chemoattractant growth factors. The objective of the present study was to determine if PRP can increase tibiofemoral cartilage regeneration and improve knee function.
| Condition | Intervention |
|---|---|
|
Cartilage Degeneration |
Biological: platelet rich plasma injection |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Platelet-rich Plasma in Patients With Tibiofemoral Cartilage Degeneration |
Resource links provided by NLM:
Further study details as provided by Hospital Znojmo:
Primary Outcome Measures:
- Change of the width of cartilage in the knee joint assessed by magnetic resonance imaging before and after nine Platelets Rich Plasma injections. [ Time Frame: 11 months after first Platelets Rich Plasma injection ] [ Designated as safety issue: Yes ]50 patients with Grade II or III chondromalatia in the knee joint, underwent one year treatment with autologous Platelets Rich Plasma. Magnetic resonance imaging was used to evaluate cartilage thickness and degree of degeneration before and after the treatement of nine Platelets Rich Plasma injection.
Secondary Outcome Measures:
- Changes in the subjective and objective clinical outcomes before and after nine Platelets Rich Plasma injections. [ Time Frame: 11 months ] [ Designated as safety issue: Yes ]50 patients with Grade II or III chondromalatia in the knee joint, underwent one year treatment with autologous Platelets Rich Plasma. To carefully assess the subjective and objective clinical outcomes, these questionnaires were used: Lysholm score, Tegner activity score, IKDC scores, and Cincinnati score. All these scores were recompleted 11 months after the beginning of the Platelets Rich Plasma injections.
| Enrollment: | 50 |
| Study Start Date: | January 2009 |
| Study Completion Date: | July 2011 |
| Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: platelet rich plasma injection
Fifty consecutive and strictly selected patients, affected by Grade II or III chondromalacia, underwent one year treatment (9 injections) with autologous PRP in a liquid form with 2,0 to 2,5-fold platelets concentration. Outcome measures included the Lysholm, Tegner, IKDC, and Cincinnati scores. Magnetic resonance imaging was used to evaluate cartilage thickness and degree of degeneration.
|
Biological: platelet rich plasma injection
The approximate 2.0 to 2.5-fold platelet concentration (taking into consideration the mean human blood platelet count of 200 000 /μl) was achieved in all specimens. Mean platelet concentration in PRP was 459 000 /μl (range, 407 000 /μl to 513 000 /μl).
|
Detailed Description:
Fifty consecutive and strictly selected patients, affected by Grade II or III chondromalacia, underwent one year treatment (9 injections) with autologous PRP in a liquid form with 2,0 to 2,5-fold platelets concentration. Outcome measures included hte Lysholm, Tegner, IKDC, and Cincinnati scores. Magnetic resonance imaging was used to evaluate cartilage thickness and degree of degeneration.
Eligibility| Ages Eligible for Study: | 31 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- isolated Grade II or Grade III nontraumatic chondromalacia according to Outerbridge grading scale
Exclusion Criteria:
- Grade I (only softening) or Grade IV (exposed subchondral bone) tibiofemoral chondromalacia;
- patellofemoral chondral damage;
- associated intraarticular lesions confirmed during arthroscopy (menisci, ligaments, osteochondral defects);
- associated extraarticular lesions confirmed by magnetic resonance imaging (ligaments, tendons, bursae);
- lower limb axial deviation confirmed by whole leg weight-bearing radiograph; knee trauma in patients history;
- body mass index (BMI) higher than 35;
- hyaluronic acid intraarticular injection 6 months prior the arthroscopy and up to last follow-up control;
- steroids intraarticular injection 3 months prior the arthroscopy and up to last follow-up control;
- symptomatic slow acting drugs for osteoarthritis (SYSADOA) and/or non-steroidal anti-inflammatory drugs (NSAID) administration during the PRP treatment;
- systemic autoimmune rheumatic and/or polyarticular disease; gout, pseudogout and hyperuricaemia.
- Other exclusion criteria included: non-informed consent; treated knee injury during the PRP therapy; PRP injection cycle not completed; impediments to fill out the questionnaires; blood disease and/or immunosuppressant treatment and/or dicoumarol therapy; immunosuppressant and/or neoplastic and/or infectious diseases.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Komzak Martin, M.D., Hart Radek, M.D., Ph.D., FRS, prof.; Orthopaedic- Traumatologic department, Hospital Znojmo |
| ClinicalTrials.gov Identifier: | NCT01418755 History of Changes |
| Other Study ID Numbers: | NT12057 |
| Study First Received: | August 15, 2011 |
| Last Updated: | September 14, 2011 |
| Health Authority: | Czech Republic: Ethics Committee |
Keywords provided by Hospital Znojmo:
|
Platelet-Rich Plasma Knee Tibiofemoral Chondromalacia Injection |
ClinicalTrials.gov processed this record on May 23, 2013