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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01610505
Recruitment Status : Active, not recruiting
First Posted : June 4, 2012
Last Update Posted : June 15, 2017
Information provided by (Responsible Party):

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Device: KIneSpring System Device: High Tibial Osteotomy Not Applicable

Detailed Description:

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 227 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : May 2012
Actual Primary Completion Date : May 2017
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: KineSpring System
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: KIneSpring System
Surgical treatment intended to reduce or eliminate pain and improve the function of a knee affected by medial compartment osteoarthritis.
Other Names:
  • KineSpring
  • Joint unloading
  • Knee Surgery
  • Arthroplasty

Active Comparator: High Tibial Osteotomy
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: High Tibial Osteotomy
Surgical treatment intended to reduce or eliminate pain and improve the function of a knee affected by medial compartment osteoarthritis.
Other Name: HTO

Primary Outcome Measures :
  1. 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 ]
  2. Safety: A measurement of procedure and device-related complication rates. [ Time Frame: 24 months post-operative ]

Secondary Outcome Measures :
  1. Change in knee pain severity (VAS) [ Time Frame: 6 weeks, and 3, 6, 12 and 24 months postoperatively compared to baseline ]
  2. Changes in EQ-5D scores [ Time Frame: 6 weeks and 3, 6, 12 and 24 months postoperatively compared to baseline ]
  3. Changes in knee outcome measures (Knee Society, WOMAC, HAAS and KOOS) scores [ Time Frame: 6 weeks and 3, 6, 12 and 24 months postoperatively compared to baseline ]
  4. Knee Range of motion [ Time Frame: 6 weeks and 3, 6, 12 and 24 months postoperatively compared to baseline ]
  5. Radiographic changes [ Time Frame: 3, 12 and 24 months postoperatively compared to baseline ]
  6. Patient Assessment of Global Status [ Time Frame: 6 weeks and 3, 6, 12 and 24 months postoperatively compared to baseline ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   25 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or female subjects 25 to 80 years of age
  • Documented diagnosis of knee OA
  • 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 conservative treatment with continued OA pain
  • Knee flexion range ≥90-≤150 degrees
  • WOMAC pain score of at least 40 (scale 0-100) at the baseline visit
  • 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 (plus additional criteria not listed):

  • 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 or pathologic fractures 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
  • 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).
  • Under 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01610505

Ghent University, Department of Orthopaedic Surgery
Ghent, Belgium, 9000
St. Vinzenz-Krankenhaus Hanau gGmbH
Hanau, Frankfurt, Germany, 63450
Krankenhaus Rummelsberg gGmbH
Rummelsberg 71, Schwarzenbruck, Germany, 90592
Berlin(Steglitz), Germany, 12163
Department für Orthopädie und Traumatologie Klinikum der Albert Ludwigs Universität Freiburg
Freiburg, Germany, 79106
Universitatsmedizin Greifswald
Greifswald, Germany, 17475
Orthopädische Gemeinschaftspraxis
Grosshansdorf, Germany, 22927
Sportklinik Halle - Zentrum fur Gelenkchirurgie
Halle, Germany, 06108
OrthoCentrum Hamburg
Hamburg, Germany, 20149
Orthopädische Klinik der MHH im Annastift
Hannover, Germany, 30625
Katholisches Klinikum Brüderhaus
Koblenz, Germany, 56073
University Clinic of Magdeburg
Magdeburg, Germany, 39120
Praxis Klinik Werneck
Werneck, Germany, 97440
Medical Center Alkmaar
Alkmaar, Netherlands
LEKMED Klinika
Warsaw, Poland
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
Robert Jones & Agnes Hunt Orthopaedic and District Hospital
Oswestry, Shropshire, United Kingdom, SY10 7AG
University Hospital Llandough
Cardiff, United Kingdom, CF14 4XW
Sponsors and Collaborators
Principal Investigator: Gerrit Bode, MD Principal Investigator for Lead IRB Site - Albert Ludwigs Universität Freiburg, Freiburg, Germany

Responsible Party: Moximed Identifier: NCT01610505     History of Changes
Other Study ID Numbers: KINE-1101
First Posted: June 4, 2012    Key Record Dates
Last Update Posted: June 15, 2017
Last Verified: March 2017

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

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