Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00004388

Trial Description

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Title

Global, Prospective, Multi-Center, Non-randomized, Controlled Non-inferiority Trial to Evaluate Symptom Relief in Patients With Medial Knee Osteoarthritis Treated With the KineSpring® Knee Implant for Load Reduction Compared to HTO

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Trial Acronym

GOAL

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URL of the Trial

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Brief Summary in Lay Language

The purpose of the post-market study is to demonstrate that the KineSpring System is
non-inferior to high tibial osteotomy in safety and effectiveness in the treatment of
symptoms associated with osteoarthritis of the medial compartment of the knee. The primary
objective of the study will be to:

- Demonstrate the non-inferiority of the KineSpring System compared to the standard
surgical, high tibial osteotomy procedure in improving pain and function outcomes (as
measured by the WOMAC pain and function subscales) at 24 months in patients with
primarily uni-compartmental medial knee osteoarthritis.

- Demonstrate that the KineSpring System is safe as measured by procedure and
device-related complication rates through 24 months post-operatively

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Brief Summary in Scientific Language

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00004388
  •   2014/10/28
  •   2012/05/31
  •   no
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Secondary IDs

  •   NCT01610505  (ClinicalTrials.gov)
  •   KINE-1101  (Moximed)
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Health Condition or Problem studied

  •   Osteoarthritis
  •   M17 -  Gonarthrosis [arthrosis of knee]
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Interventions/Observational Groups

  •   Device: Medial knee compartment osteoarthritis treatment - surgical
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Active control
  •   Treatment
  •   Parallel
  •   N/A
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Primary Outcome

- Western Ontario and McMaster Universities Arthritis (WOMAC) Pain and Function subscales. WOMAC: Self-administered, validated assessment of the three dimensions of pain, disability and joint stiffness in knee and hip osteoarthritis.; time frame: 24 months post-operative
- Safety: A measurement of procedure and device-related complication rates.; time frame: 24 months post-operative

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Secondary Outcome

- Changes in knee pain severity; time frame: 6 weeks, and 3, 6, 12 and 24 months postoperatively compared to baseline
- Changes in EQ-5D scores; time frame: 6 weeks and 3, 6, 12 and 24 months postoperatively compared to baseline
- Changes in knee outcome measures (Knee Society, WOMAC, and KOOS) scores; time frame: 6 weeks and 3, 6, 12 and 24 months postoperatively compared to baseline

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Countries of Recruitment

  •   Belgium
  •   Germany
  •   Luxembourg
  •   United Kingdom
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Locations of Recruitment

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Recruitment

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  •   2012/05/31
  •   225
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Inclusion Criteria

  •   Both, male and female
  •   25   Years
  •   80   Years
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Additional Inclusion Criteria

- Male or female subjects 25 to 80 years of age

- Documented diagnosis of knee OA with a minimum of 12 months duration

- Radiographic confirmation of mild to moderate medial compartment knee OA as
demonstrated by a Kellgren-Lawrence grade of 1, 2 or 3 (scale 0-4) as assessed by the
Investigator

- Has failed at least six months of non-operative treatment with continued OA pain

- Knee flexion range ≥90 - ≤140 degrees

- WOMAC pain score of at least 40 (scale 0-100) at both the screening and baseline
visits

- BMI < 35 or weight < 300 lbs

- Candidate for a high tibial osteotomy procedure

- 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, cooperate with the investigational procedures and are
willing to return for all the required post-treatment follow-ups.

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Exclusion Criteria

- Symptomatic OA with Kellgren Lawrence Grade 4 in the contralateral knee likely to
necessitate surgical intervention within 12 months of enrollment

- Symptomatic OA in lateral or patellofemoral compartment of affected knee

- Tibial-femoral varus or valgus alignment >10 degrees

- Flexion deformity > 10 degrees

- Hyperextension >5 degrees

- Pathologic ligamentous instability (>1 MCL injury or Lachman >1) as assessed by the
Investigator on physical examination

- Active infection, sepsis or osteomyelitis, history of infection in the target knee or
distant foci of infections which may spread to the implant site

- Previous joint modifying surgery in the target knee are excluded within 12 months
prior to planned study surgery date, such as ligament reconstruction or meniscus
repair, cartilage transplantation, and microfracture. Arthroscopic surgeries for
joint lavage, menisectomy, chondral debridement, and loose body removal are excluded
within 3 months prior to planned study surgery date.

- Previous osteotomy or failed knee joint replacement in the target knee

- Known sensitivity to metal implants

- Rheumatoid arthritis, other forms of inflammatory joint disease or autoimmune
disorder

- Paget's disease or metabolic disorders which may impair bone formation

- Moderate to severe osteoporosis as evidenced by radiolucency of the femoral or tibial
cortex on x-ray

- Charcot's joint disease or other severe neurosensory deficits

- Immunologically suppressed or immunocompromised

- Currently taking medications that affect bone metabolism, including steroids and
chemotherapy, or are undergoing radiotherapy.

- Any significant medical condition (e.g., diabetes mellitus requiring daily insulin
therapy, advanced liver disease, advanced kidney disease, congestive cardiac failure,
uncontrolled transient ischemic attack, cancer, radicular symptoms associated with
lumbar spine pathology); significant psychiatric disorders or active alcohol/drug
abuse (meeting standard diagnostic criteria described in the Diagnostic and
Statistical manual for Mental Disorders (DSM-IV; or other factor (e.g. planned
relocation, uncooperative patient) that the Investigator feels would interfere with
study participation.

- Litigation for or workers compensation for musculoskeletal injuries or disorders

- Is either pregnant or interested in becoming pregnant during the duration of the
study

- Subjects who are currently involved in any investigational drug or device trial or
have been enrolled in such trials within the last 3 months

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Addresses

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    • Moximed
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    • Principal Investigator for Lead IRB Site - Albert Ludwigs Universität Freiburg, Freiburg, Germany
    • Philipp Niemeyer, MD 
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    • Principal Investigator for Lead IRB Site - Albert Ludwigs Universität Freiburg, Freiburg, Germany
    • Philipp Niemeyer, MD 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   2
  •   2014/11/27
* This entry means the parameter is not applicable or has not been set.