Rheumatoid Arthritis Trial, Recruiting NCT03048201 Sponsor: Limacorporate S.p.a Condition: Rheumatoid Arthritis
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Rheumatoid Arthritis Trial, Recruiting

NCT03048201
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are male or female, of any race, and your doctor has recommended a total knee replacement
  • You are over 22 years old and your bones have finished growing
  • You have a knee condition such as osteoarthritis, arthritis caused by a previous injury, inflammatory arthritis (such as rheumatoid arthritis), or a knee deformity that needs correcting
  • The ligaments on the sides of your knee (collateral ligaments) are intact and working normally
  • Depending on which version of the knee implant is used, the ligament at the back of your knee (posterior cruciate ligament) may need to be intact, or may not be required (confirm with trial site)
  • You understand what the study involves and are willing and able to follow the recommended rehabilitation programme and attend all required follow-up appointments
  • You have read and signed the informed consent form approved by the Ethics Committee before your surgery

Who may not be able to join:

  • Your knee is severely unstable because the ligaments on the sides of your knee are damaged or not working
  • You have an active infection or suspected infection, either in your knee or anywhere in your body
  • You have previously had a partial knee replacement, had your kneecap removed, or had a surgery to reshape your shin bone (high tibial osteotomy)
  • You have significant bone loss in the knee area
  • You are currently being treated for cancer or another serious life-threatening illness
  • You have a known allergy or sensitivity to the materials used in the implant, including metals
  • You have poor blood circulation in your legs that is severe enough to affect the study results
  • Your bone quality is too poor — due to disease, infection, or a previous implant — to properly support the new knee implant
  • You have a condition that causes ongoing bone deterioration that could affect how well the implant stays in place
  • You have any other condition or dependency that could affect how well the implant works
  • You have a significant medical history that the trial doctor believes could affect the study results, such as severe osteoporosis, a blood clotting disorder, blood poisoning, or a bone infection (confirm with trial site)
  • You have a neurological or musculoskeletal condition that significantly affects the way you walk or could slow your recovery
  • You have a nerve or sensory condition that would make it difficult to assess how well the implant is performing
  • You have a history of infection in the affected knee joint, or another infection that could affect the implant
  • You have a psychiatric illness that would prevent you from fully understanding what the study involves
  • You are currently taking part in another surgical or pain management study
  • You are pregnant, breastfeeding, or planning to become pregnant

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 20 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Fabiana Pavan, Limacorporate S.p.a

Phone: +390432945357

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Limacorporate S.p.a
Registry
ClinicalTrials.gov
Start date
24 March 2017
Est. completion
1 March 2030

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Implant Survivorship

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 20 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov