Efficacy of intra-articular polynucleotides in the treatment of knee osteoarthritis

ISRCTN ISRCTN77293496
DOI https://doi.org/10.1186/ISRCTN77293496
Secondary identifying numbers plinart 02/06
Submission date
09/04/2009
Registration date
20/04/2009
Last edited
20/04/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Roberto Vanelli
Scientific

IRCCS Foundation
Orthopaedic and Traumatology Department
S. Matteo Hospital Institute
University of Pavia
Viale golgi 19
Pavia
27100
Italy

Study information

Study designRandomised controlled double-blind parallel group clinical trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleEfficacy of intra-articular polynucleotides in the treatment of knee osteoarthritis: a controlled, randomised, double-blind clinical trial
Study objectivesThe ideal intra-articular treatment for osteoarthritis (OA) should not only provide a mechanical protection of the cartilage surface, but also restore chondrocytes' homeostasis by restoring the physiological articular micro-enivronment and supplying nutrients.

Polynucleotides (PN) are polymeric molecules which are able to bind a large amount of water and to re-organise their structure by orienting and co-ordinating water molecules to form a 3-D gel. Polynucleotides when infiltrated at intra-articular level, can deeply moisturise articular surfaces. Polynucleotides, simple nucleotides, nucleosides and nitrogen bases are physiologically present in the extra-cellular environment and are useful substrates for cells. Intra-articular infiltration progressively enriches the synovial fluid of PN and thus of nucleotides, purine and pyrimidine bases that tissues can use to promote physiological repair mechanisms.
Ethics approval(s)The Ethics Committee of the Clinical Centre (IRCCS Foundation, Orthopaedic and Traumatology Department, S. Matteo Hospital Institute, University of Pavia, Pavia-Italy) approved on the 10th October 2006 (ref: 256)
Health condition(s) or problem(s) studiedKnee osteoarthritis
InterventionThe product under study is a class III medical device, a gel, consisting of highly purified - natural origin long chain polynucleotides (20 mg/ml concentration). It is marked in a pre-filled glass syringe with 2 ml of high molecular weight sterile and apirogenic polynucleotides (batch n° 605553), trade name Turnover Joint and Condrotide (Mastelli Srl, Italy).

Control group was treated with hyaluronic acid (HA) in pre-filled glass syringe with 2 ml of 8 mg/ml hyaluronic acid (Sinovial, batch n° 050727, Laboratoires Genévrier, Sophia Antipolis, France).

Patients of Group A (treatment group) received five 2 ml intra-articular injections with an interval of one week between the injections (from week 0 to week 4) of 40 mg/2 ml polynucleotides.

Group B patients (control group) received five 2 ml intra-articular injections with an interval of one week between the injections (from week 0 to week 4) of 16 mg/2 ml hyaluronic acid.
Intervention typeDrug
Pharmaceutical study type(s)
PhasePhase IV
Drug / device / biological / vaccine name(s)Long chain polynucleotides
Primary outcome measureChange in the pain level at rest, at weight-bearing, and during physical activity, at all timepoints from baseline (T0) to T16.

Timepoints:
T0: Inclusion visit
T1: After one week
T2: After two weeks
T3: After three weeks
T4: After four weeks (end of treatment period)
T8: First follow-up visit, after eight weeks
T16: End of the trial, after 16 weeks
Secondary outcome measures1. Evaluation of Knee Osteoarthritis Outcome Score (KOOS) results, measured at T0, T4, T8 and T16
2. Non-steroidal anti-inflammatory drug (NSAID) consumption, at all timepoints from baseline (T0) to T16
3. Crackling during movement and articular mobility limitation (LMA), at all timepoints from baseline (T0) to T16
4. Safety profile of the devices, assessed by recording adverse events at each visit

Timepoints:
T0: Inclusion visit
T1: After one week
T2: After two weeks
T3: After three weeks
T4: After four weeks (end of treatment period)
T8: First follow-up visit, after eight weeks
T16: End of the trial, after 16 weeks
Overall study start date01/12/2006
Completion date20/12/2007

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants60
Key inclusion criteria1. Aged between 18 and 80 years, either sex
2. Affected by knee osteoarthritis (diagnosis based on the American College of Rheumatology [ACR] classification)
3. Developed persistent pain for at least two months
Key exclusion criteria1. Alcohol or drug abuse
2. Pregnancy or breastfeeding
3. Hypersensibility to study products
4. Hyaluronic acid or steroid infiltration therapy ongoing or suspended for less than 3 months
5. Systemic treatment with anticoagulants and steroids ongoing or suspended for less than 1 month
6. Previous bone fractures or severe traumas of the interested knee
7. Presence of rheumatoid arthritis and of relevant haematological pathologies
Date of first enrolment01/12/2006
Date of final enrolment20/12/2007

Locations

Countries of recruitment

  • Italy

Study participating centre

IRCCS Foundation
Pavia
27100
Italy

Sponsor information

Mastelli Srl (Italy)
Industry

Via bussana vecchia 32
Sanremo
18038
Italy

http://www.mastelli.it
ROR logo https://ror.org/003r56a21

Funders

Funder type

Industry

Mastelli Srl (Italy)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan
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