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Health Condition(s) or Problem
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Osteoarthritis; Post-traumatic Arthritis; Gout; Pseudo-gout
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Lay Summary
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This is a postmarketing study to assess the overall performance and survivorship of the
SIGMA HP® PARTIAL KNEE SYSTEM.
(from ClinicalTrials.gov)
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Who can enter the trial
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Inclusion Criteria:
- Male or female subjects, aged at least 21 years.
- Subjects who are able to give voluntary, written informed consent to participate in
this clinical investigation and from whom consent has been obtained.
- Subjects, who, in the opinion of the Clinical Investigator, are able to understand
this clinical investigation, co-operate with the investigational procedures and are
willing to return to the hospital for all the required post-operative follow-ups.
- Subject has non-inflammatory degenerative joint disease (NIDJD), including: OA,
posttraumatic arthritis, avascular necrosis and chondrocalcinosis.
- Subject has a functional stable knee.
- Subject, in the opinion of the Investigator, is suitable for either a single or
bicompartmental knee replacement.
- Subject meets the following selected radiographic parameters:
- X-ray evaluation confirms the presence of NIDJD
- Disease location: 1 to 2 compartments, maximum. Disease can be present in the
patellofemoral compartment, the medial tibiofemoral compartment, lateral
tibiofemoral compartments alone or in any two compartments.
- Disease severity: Kellgren and Lawrence44 Grade II or greater for all
compartments replaced.
Exclusion Criteria:
- Subjects who, in the opinion of the Clinical Investigator, have an existing condition
that would compromise their participation and follow-up in this clinical
investigation.
- Women who are pregnant.
- Subjects who are known drug or alcohol abusers or with psychological disorders that
could affect follow-up care or treatment outcomes.
- Subjects who have participated in a clinical investigation with an investigational
product in the last 3 months.
- Subjects who are currently involved in any injury litigation claims.
- Multiple joint involvement that will compromise rehabilitation (for example:
advanced hip, ankle or spine disease).
- Known to be a prisoner, mentally incompetent, an alcohol / drug abuser, involved in
medical-legal case or worker's compensation
- Previous knee arthroplasty (any type) in any one of the three compartments of the
knee.
- Requires more than a lateral soft tissue release or an anterior cruciate ligament
reconstruction.
- Uncorrectable anatomical tibio-femoral angle.
- Bone deficiency requiring structural bone grafts to support the implants.
- Previous patellectomy.
- For Subjects indicated for a PFA, Subject has uncorrected patella baja
(Caton-Deschamps ratio less than or equal to 0.6).
- Tri-compartmental disease process (patella-femoral, medial tibio-femoral and lateral
tibio-femoral).
- Active bacterial infection that may spread to other areas of the body (e.g.,
osteomyelitis, pyogenic infection of knee joint, urinary tract infection, etc.).
- Significant neurological or musculoskeletal deformity or a disease that may affect
gait or weight bearing, (e.g., muscular dystrophy, multiple sclerosis, amputation).
- Known allergy to implant materials.
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Who cannot enter the trial
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Inclusion Criteria:
- Male or female subjects, aged at least 21 years.
- Subjects who are able to give voluntary, written informed consent to participate in
this clinical investigation and from whom consent has been obtained.
- Subjects, who, in the opinion of the Clinical Investigator, are able to understand
this clinical investigation, co-operate with the investigational procedures and are
willing to return to the hospital for all the required post-operative follow-ups.
- Subject has non-inflammatory degenerative joint disease (NIDJD), including: OA,
posttraumatic arthritis, avascular necrosis and chondrocalcinosis.
- Subject has a functional stable knee.
- Subject, in the opinion of the Investigator, is suitable for either a single or
bicompartmental knee replacement.
- Subject meets the following selected radiographic parameters:
- X-ray evaluation confirms the presence of NIDJD
- Disease location: 1 to 2 compartments, maximum. Disease can be present in the
patellofemoral compartment, the medial tibiofemoral compartment, lateral
tibiofemoral compartments alone or in any two compartments.
- Disease severity: Kellgren and Lawrence44 Grade II or greater for all
compartments replaced.
Exclusion Criteria:
- Subjects who, in the opinion of the Clinical Investigator, have an existing condition
that would compromise their participation and follow-up in this clinical
investigation.
- Women who are pregnant.
- Subjects who are known drug or alcohol abusers or with psychological disorders that
could affect follow-up care or treatment outcomes.
- Subjects who have participated in a clinical investigation with an investigational
product in the last 3 months.
- Subjects who are currently involved in any injury litigation claims.
- Multiple joint involvement that will compromise rehabilitation (for example:
advanced hip, ankle or spine disease).
- Known to be a prisoner, mentally incompetent, an alcohol / drug abuser, involved in
medical-legal case or worker's compensation
- Previous knee arthroplasty (any type) in any one of the three compartments of the
knee.
- Requires more than a lateral soft tissue release or an anterior cruciate ligament
reconstruction.
- Uncorrectable anatomical tibio-femoral angle.
- Bone deficiency requiring structural bone grafts to support the implants.
- Previous patellectomy.
- For Subjects indicated for a PFA, Subject has uncorrected patella baja
(Caton-Deschamps ratio less than or equal to 0.6).
- Tri-compartmental disease process (patella-femoral, medial tibio-femoral and lateral
tibio-femoral).
- Active bacterial infection that may spread to other areas of the body (e.g.,
osteomyelitis, pyogenic infection of knee joint, urinary tract infection, etc.).
- Significant neurological or musculoskeletal deformity or a disease that may affect
gait or weight bearing, (e.g., muscular dystrophy, multiple sclerosis, amputation).
- Known allergy to implant materials.
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What will happen
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Device; SIGMA HP PARTIAL KNEE; SIGMA HP PARTIAL KNEE; Sigma HP Partial Knee; Sigma HP Partial Knee Femoral component; Sigma HP Partial Knee Tibial component; Sigma HP Partial Knee Tibial insert component; Sigma Patellae; Sigma HP Partial Knee Trochlear component
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Primary aim
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Survivorship (revision)
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Secondary Aim
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Survivorship; 1, 2, 5 and 10 years; Yes; Survival analyses at each post-operative assessment.; Knee Society Score; 1, 2, 5 and 10 years; No; Mean change from baseline (pre-op) to each post-operative assessment; KOOS; 1, 2, 5 and 10 years; No; Mean change from baseline (pre-op) to each post-operative assessment.; HAAS; 1, 2, 5 and 10 years; No; Mean change from baseline (pre-op) to each post-operative assessment.; Kujala Score; 1, 2, 5 and 10 years; No; Mean change from baseline (pre-op) to each post-operative assessment.; Oxford Knee Score; 1, 2, 5 and 10 years; No; Mean change from baseline (pre-op) to each post-operative assessment.; EQ-5D; 1, 2, 5 and 10 years; No; Mean change from baseline (pre-op) to each post-operative assessment.; Radiographic Analysis; 1, 2, 5 and 10 years; Yes; Change from 6 week post-operative assessment at all post-operative timepoints to identify the number of implants that are 'at risk'.
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Participant Information Sheet
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Sorry, not currently available
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Website
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Sorry, not currently available
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Recruitment Status
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Recruiting
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Nation
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England
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Location
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Harrogate, York
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