A Study of the KineSpring System Versus High Tibial Osteotomy Surgery for the Treatment of Medial Compartment Knee Osteoarthritis (GOAL)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Moximed
ClinicalTrials.gov Identifier:
NCT01610505
First received: May 31, 2012
Last updated: November 1, 2013
Last verified: November 2013
  Purpose

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

Condition Intervention
Osteoarthritis
Device: Medial knee compartment osteoarthritis treatment - surgical

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Moximed:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Safety: A measurement of procedure and device-related complication rates. [ Time Frame: 24 months post-operative ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Changes in knee pain severity [ Time Frame: 6 weeks, and 3, 6, 12 and 24 months postoperatively compared to baseline ] [ Designated as safety issue: No ]
  • Changes in EQ-5D scores [ Time Frame: 6 weeks and 3, 6, 12 and 24 months postoperatively compared to baseline ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 225
Study Start Date: May 2012
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: KineSpring System Treatment
The KineSpring System is implanted through two medial incisions, one on the distal femur and one on the proximal tibia. Femoral and Tibial bases are fixed with screws to the femur and tibia. An absorber connects the two bases and offloads forces normally transmitted to the medial compartment of the knee.
Device: Medial knee compartment osteoarthritis treatment - surgical
Surgical treatment intended to reduce or eliminate pain and improve the function of a knee affected by medial compartmental osteoarthritis.
Other Names:
  • High Tibial Osteotomy
  • HTO
  • Knee Surgery
  • Arthroplasty
Active Comparator: High Tibial Osteotomy Treatment
There are two ways to perform a high tibial osteotomy: a closed wedge osteotomy (CWO) or an open wedge osteotomy (OWO). An OWO cuts the bone, increases the angle and fills the gap with bone graft. A CWO removes a wedge of bone to achieve the change of angle. The surgery involves the gaping or wedging of a piece of bone and its removal to change the pressure points of weight-bearing activity, thus redistributing the load to the unaffected compartments of the knee. The cut surfaces of the bone are typically held together with a plate and screw system.
Device: Medial knee compartment osteoarthritis treatment - surgical
Surgical treatment intended to reduce or eliminate pain and improve the function of a knee affected by medial compartmental osteoarthritis.
Other Names:
  • High Tibial Osteotomy
  • HTO
  • Knee Surgery
  • Arthroplasty

  Eligibility

Ages Eligible for Study:   25 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01610505

Locations
Belgium
Ghent University, Department of Orthopaedic Surgery
Ghent, Belgium, 9000
Germany
St. Vinzenz-Krankenhaus Hanau GmbH Center for Joint Surgery Orthopaedic and Trauma Surgery
Hanau, Frankfurt, Germany, 63450
GWZ-Steglitz
Berlin(Steglitz), Germany, 12163
Department Orthopädie und Traumatologie Klinikum der Albert Ludwigs Universität Freiburg
Freiburg, Germany, 79106
Universitatsmedizin Greifswald
Greifswald, Germany, DE-17475
Orthopadische Gemeinschaftspraxis
Grosshansdorf, Germany, 22927
Sportklinik Halle - Zentrum fur Gelenkchirurgie
Halle, Germany, 06108
OrthoCentrum Hamburg
Hamburg, Germany, 20149
Orthopadische Klinik der MHH im Annastift
Hannover, Germany, D-30625
Katholisches Klinikum Bruderhaus
Koblenz, Germany, 56073
University Clinic of Magdeburg
Magdeburg, Germany, 39120
Praxis Klinik Werneck
Werneck, Germany, 97440
Luxembourg
Centre Hospitalier de Luxembourg - Clinique d' Eich
Eich, Luxembourg, L-1460
United Kingdom
The Royal Bournemouth Hospital and Christchurch Hospitals, NHS Foundation Trust
Bournemouth, Dorset, United Kingdom, BH7 7DW
Basingstoke and North Hampshire Hospital, NHS Foundation Trust
Basingstoke, Hampshire, United Kingdom, RG24 9NA
Aintree University Hospital
Liverpool, Merseyside, United Kingdom, L9 7AL
Sponsors and Collaborators
Moximed
Investigators
Principal Investigator: Philipp Niemeyer, MD Principal Investigator for Lead IRB Site - Albert Ludwigs Universität Freiburg, Freiburg, Germany
  More Information

No publications provided

Responsible Party: Moximed
ClinicalTrials.gov Identifier: NCT01610505     History of Changes
Other Study ID Numbers: KINE-1101
Study First Received: May 31, 2012
Last Updated: November 1, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by Moximed:
Knee Osteoarthritis
Knee pain
Arthritis
KineSpring
High Tibial Osteotomy

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on September 18, 2014