Cartilage DegenerationNCT01418755
Study of Platelet-rich Plasma in Treating Patients With Tibiofemoral Cartilage Degeneration
A study testing platelet rich plasma injection in people with Cartilage Degeneration, run by Komzak Martin, M.D. at 1 site in Czechia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 31 to 75 years
- Conditions the study is for
- Cartilage Degeneration
- What is being tested?
- platelet rich plasma injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCzechia
- Study dates
- Jan 2009to Jul 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 31 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- isolated Grade II or Grade III nontraumatic chondromalacia according to Outerbridge grading scale
Who cannot join
- 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;
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Platelet-rich Plasma in Patients With Tibiofemoral Cartilage Degeneration
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.
Read the 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.
- Conditions
- Cartilage Degeneration
- Being tested
- platelet rich plasma injection
- Keywords
- Platelet-Rich Plasma, Knee, Tibiofemoral Chondromalacia, Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
platelet rich plasma injectionBiological
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).
| Study group | Role | What they receive |
|---|---|---|
| platelet rich plasma injection | Experimental | 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. Receives: Biological: platelet rich plasma injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the width of cartilage in the knee joint assessed by magnetic resonance imaging before and after nine Platelets Rich Plasma injections.
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.
Measured: 11 months after first Platelets Rich Plasma injection
Secondary outcomes (1)
Changes in the subjective and objective clinical outcomes before and after nine Platelets Rich Plasma injections.
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.
Measured: 11 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2011 (estimated)
- Study startJan 2009
- Primary completionNov 2009
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cartilage DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Komzak Martin, M.D.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Komzak Martin, M.D., Hospital Znojmo
- Investigators
- Radek Hart, prof, M.D., Principal investigator, Hospital Znojmo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01418755
- Sponsor's protocol ID
- NT12057
- Status last verified
- Sep 2011
- First submitted
- 15 Aug 2011
- Last updated
- 15 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet-rich Plasma in Patients With Tibiofemoral Cartilage Degeneration
- ClinicalTrials.gov ID
- NCT01418755
- Acronym / sponsor ID
- NT12057
- Conditions
- Cartilage Degeneration
- Keywords
- Platelet-Rich Plasma, Knee, Tibiofemoral Chondromalacia, Injection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Komzak Martin, M.D.University, hospital or other
- Study start
- Jan 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 17 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| platelet rich plasma injection | Experimental | Biological: platelet rich plasma injectionFifty 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. |
Who may qualify
- Ages
- 31 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- isolated Grade II or Grade III nontraumatic chondromalacia according to Outerbridge grading scale
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| platelet rich plasma injectionThe 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). | Biological | platelet rich plasma injection |
Primary outcome
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
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.
1 secondary outcome
Changes in the subjective and objective clinical outcomes before and after nine Platelets Rich Plasma injections.
Time frame: 11 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2011.
- web site of Investigator´s institutionLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Radek Hart, prof, M.D. principal investigator
Hospital Znojmo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing platelet rich plasma injection in people with Cartilage Degeneration, run by Komzak Martin, M.D. at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2011.