Condition category
Musculoskeletal Diseases
Date applied
09/04/2009
Date assigned
20/04/2009
Last edited
20/04/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Roberto Vanelli

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

plinart 02/06

Study information

Scientific title

Efficacy of intra-articular polynucleotides in the treatment of knee osteoarthritis: a controlled, randomised, double-blind clinical trial

Acronym

Study hypothesis

The 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

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)

Study design

Randomised controlled double-blind parallel group clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Knee osteoarthritis

Intervention

The 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 type

Drug

Phase

Phase IV

Drug names

Long chain polynucleotides

Primary outcome measures

Change 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 measures

1. 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 trial start date

01/12/2006

Overall trial end date

20/12/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60

Participant exclusion criteria

1. 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

Recruitment start date

01/12/2006

Recruitment end date

20/12/2007

Locations

Countries of recruitment

Italy

Trial participating centre

IRCCS Foundation
Pavia
27100
Italy

Sponsor information

Organisation

Mastelli Srl (Italy)

Sponsor details

Via bussana vecchia 32
Sanremo
18038
Italy

Sponsor type

Industry

Website

http://www.mastelli.it

Funders

Funder type

Industry

Funder name

Mastelli Srl (Italy)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes