Ortho Research

Clinical Trials

Subchondroplasty

Study Contact:

Kaitlyn Shank 434-243-5653

IRB-HSR 21109

Clinic Visit Registration: 21109- Diduch

Inclusion Criteria

  • Male or female subjects between the ages of 30 to 75 years
  • Body Mass Index ≤ 40 (BMI=kg/m2)
  • Has experienced pain in study knee for at least 3 months
  • Kellgren-Lawrence grade 1-3 Osteoarthritis as reviewed on preoperative XR imaging, in the study knee,
    • Grade 0: no radiographic features of OA are present
    • Grade 1: doubtful joint space narrowing (JSN) and possible osteophytic lipping
    • Grade 2: definite osteophytes and possible JSN on anteroposterior weight-bearing radiograph
    • Grade 3: multiple osteophytes, definite JSN, sclerosis, possible bony deformity
    • Grade 4: large osteophytes, marked JSN, severe sclerosis and definite bony deformity with complete loss of joint space (bone-on-bone) or subchondral bone collapse
  • BML is confirmed on T2 weighted or Proton Density MR Imaging by presence of white signal
  • Single BML of tibia, single BML of femur, or adjoining BML’s of tibia & femur, in the same compartment, extending to the articular surface of the joint
  • Surgical candidate for knee arthroscopy due to mechanical symptoms, meniscus tear, loose body and/or synovitis
  • Must record a response, at the preoperative study visit, of moderate to extreme pain for any one of the KOOS Pain Scale questions, P2 through P9
  • Index knee alignment is defined radiographically as one of the following: Neutral, ≤ 6° mechanical varus, or ≤ 6° mechanical valgus
  • Ligaments in the study knee are stable
  • The contralateral (non-study) knee is stable and functional
  • Is refractory to conservative non-surgical management
    • having failed 2 or more of the following: hyaluronic acid injection, corticosteroid injection, NSAIDs, physical therapy, bracing, activity modification, or minimal surgical intervention (e.g., arthroscopy, debridement/chondroplasty, and/or loose body removal)
    • and is ≥ 3 months from the start of treatment (these treatments can continue up to the time of the randomized procedure; preoperative injections to be completed per protocol)
  • Must be physically and mentally willing and able, in the Investigator’s opinion at the time of enrollment, to be compliant with the protocol - including all follow-up visits, survey completion, weight-bearing restrictions, and post-operative rehabilitation

Exclusion Criteria

  • BML caused by acute trauma less than 3 months prior to enrollment
  • Clinical and/or radiographic disease diagnosis of the index knee that includes any of the following
    • Kellgren-Lawrence Grade 4 Osteoarthritis, with complete loss of joint space (bone-on-bone) or subchondral bone collapse
    • Rheumatoid arthritis, or history of septic or reactive arthritis
    • Gout or a history of gout or pseudogout in the affected knee
    • Has more than two clinically relevant BMLs in the index knee
    • Osteochondritis dissecans of the knee with significant bone loss
    • Collapse of subchondral bone
    • Clinically relevant BML located at ACL/PCL insertion
    • MRI evidence of frank ligament instability
  • Passive knee flexion < 110° or flexion contracture >30°
  • History of systemic diseases which could contribute to secondary arthropathies (eg., sickle cell disease, hemochromatosis, or autoimmune disease)
  • Has a neuromuscular, neurosensory, or musculoskeletal deficiency that limits the ability to perform objective functional assessment of either knee
  • If diabetic, blood glucose over 200 mg/dL at time of enrollment
  • Current daily tobacco or high nicotine product user or < 3months from nicotine cessation
  • Presents a high surgical risk due to unstable cardiac and/or pulmonary disease
  • Has HIV or other immunodeficient state including subjects on immunosuppressant therapies, or has significant illness (metastasis of any type) that decreases the probability of survival to the 2 year endpoint
  • Is at substantial risk for the need of organ transplantation, such as renal insufficiency
  • Is pregnant or breast-feeding at the time of surgery
  • Has a history of any invasive malignancy (except non-melanoma skin cancer), unless treated with curative intent and with no clinical signs or symptoms of the malignancy for 5 years
  • Has primary bone tumor in the knee area
  • Anticipates having a lower extremity surgery other than the investigational surgery during the course of the study
  • Is participating concurrently in another clinical trial, or has participated in a clinical trial within 30 days of surgery
  • Is receiving prescription pain medication other than NSAIDs or acetaminophen for conditions unrelated to the index knee condition, chronic use of anticoagulants, or taking oral or inhaled corticosteroids
  • Active joint infection or history of chronic joint infection at the surgical site
  • Prior total meniscectomy of index knee
  • Has primarily patellofemoral symptoms
  • Is indicated for concomitant procedures (i.e., microfracture, subchondral drilling, cartilage allograft, ligament or tendon repair, distal realignment/osteotomy, root repair) in the index knee, with the exception of incidental loose body removal, debridement, synovectomy, osteophyte removal in locations other than adjacent to BMLs, and/or partial meniscectomy
  • Has contraindications for Magnetic Resonance Imaging (MRI)
  • Is receiving worker’s compensation or is currently involved in litigation relating to the index knee
  • Has a history of substance abuse

Study Summary

  • Screening ≤ 60 days of surgery: Consent, Inclusion/Exclusion, Baseline History, Baseline Questionnaires, X-Rays (AP hip to ankle, Lateral, PA Fixed Flexion (bilateral), and Sunrise), MRI
  • Surgery: Randomization to Arthroscopy only or Arthroscopy and Subchondroplasty
  • 6 weeks ± 10 days: Clinic visit, knee evaluation, x-rays (AP hip to ankle, Lateral, PA Fixed Flexion (bilateral), and Sunrise) and assessment, patient reported outcomes
  • 3 months ± 30 days: Clinic visit, knee evaluation, patient reported outcomes
  • 6 months ± 30 days: Clinic visit, knee evaluation, patient reported outcomes
  • 12 months ± 60 days: Clinic visit, knee evaluation, x-rays (AP hip to ankle, Lateral, PA Fixed Flexion (bilateral), and Sunrise) and assessment, MRI, patient reported outcomes
  • 18 months ± 60 days: Telephone visit: questionnaires over the phone
  • 24 months ± 60 days: Clinic visit, knee evaluation, x-rays (AP hip to ankle, Lateral, PA Fixed Flexion (bilateral), and Sunrise) and assessment, MRI, patient reported outcomes, study exit

Payment

$750 total

  • $75 for clinic visits (7 visits)
  • $75 for MRIs (3 total)

Covered Expenses

  • Covered by patient/insurance: Arthroscopy procedure
  • Covered by study: All visits, x-rays, MRIs, and the Subchondroplasty portion of the surgical procedure (also the all costs of crossover procedure)
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