Clinical Trials

Study Overview

Midwest Orthopaedics at Rush is enrolling patients in a Phase 3 pivotal clinical trial evaluating CARTISTEM®, an investigational treatment using cultured donor maternal cord blood stem cells for cartilage regeneration in knee osteoarthritis. This trial is led by Brian J. Cole, MD, MBA, and Adam Yanke, MD, PhD.

We are looking for patients with symptomatic knee osteoarthritis who have tried at least three months of conservative treatment without lasting relief and who are not yet ready to consider knee replacement surgery. Candidates should have imaging that confirms focal or multifocal cartilage lesions with preserved joint space, mild to moderate osteoarthritis, and reasonable limb alignment. Because the study includes a structured rehabilitation program and follow-up visits over two years, candidates should be motivated and able to commit to the full course of the study.

Who May Qualify

Failed Conservative Treatment
Patients with knee osteoarthritis who have tried conservative options, such as injections, without success, and who are not yet candidates for knee arthroplasty.

Confirmed or Suspected Cartilage Lesions
Imaging that shows or suggests focal or multifocal cartilage lesions, with preserved joint space, mild to moderate osteoarthritis, and reasonable alignment.

Ready to Commit to Rehab and Follow Up
Willingness and ability to complete a structured rehabilitation program and attend follow up visits for the full two year study period.

Sponsor

Multi-site industry-sponsored trial (N≈300)

Research Type

Randomized, prospective, double blind controlled trial

Candidate Criteria

Patients ages 18 to 75 with a BMI of 35 or under, diagnosed with knee osteoarthritis, who have failed at least 3 months of conservative treatment. Candidates must have a Kellgren Lawrence grade of 2 to 3, a specific range of femoral cartilage defect size, and pain and function scores within defined ranges. Full screening and baseline eligibility criteria apply, including limits on recent injections, other joint conditions, and certain medical histories.

Purpose

To compare pain and functional outcomes between CARTISTEM and standard surgical debridement over a two year period in patients with a focal cartilage defect and early-stage knee osteoarthritis.

Study Design

Patients are screened with X-ray, MRI, labs, and questionnaires, then complete a baseline patient-reported outcome visit within 10 days of surgery. On surgery day, half of the participants receive CARTISTEM and half receive debridement only. Patients complete a daily symptom diary between screening and their baseline visit, then again for the 7 days preceding each follow-up visit.

Study Procedures

1. Screening visit: X-ray, MRI, labs, questionnaires
2. Baseline PRO visit (within 10 days of surgery): VAS Pain, WOMAC
3. Surgery day: CARTISTEM or debridement only
4. Follow-up visits at:
   • 2 weeks (MRI)
   • 3 months
   • 6 months
   • 9 months
   • 12 months (MRI, X-ray)
   • 18 months
   • 24 months (MRI, X-ray)

Each follow-up visit includes a physical exam, knee evaluation, medication check, patient-reported outcomes, labs, and diary review.

Study Overview

Radiographic and Patient Reported Outcomes Following Arthroscopic Rotator Cuff Repair Using the CuffMend™ Augmentation Technique: A Prospective Clinical Study

Sponsor

Rush University Medical Center, Department of Orthopedic Surgery

Research Type

Prospective Case Series

Enrollment

23 enrolled, actively enrolling. Goal enrollment of 50 participants, ages 18 to 75 at the time of procedure.

Candidate Criteria

Patients with a 1 to 3 cm full-thickness rotator cuff tear who elect to have surgery. No more than 3 tendons torn, and the tear size cannot exceed 5 cm.

Purpose

To evaluate and compare radiographic and patient-reported outcomes following arthroscopic rotator cuff repair augmented with decellularized dermal allograft patch implanted using the CuffMend™ system, versus outcomes following arthroscopic rotator cuff repair without augmentation.

Study Design

A prospective case series with a 52-week minimum follow-up period, comparing standard MRI at pre op and 1 year post op. Patient-reported outcome assessments are collected preoperatively, and at 1 week, 6 weeks, 12 weeks, 24 weeks, 52 weeks (1 year), and 2 years post op.

Study Procedures

Preoperative shoulder MRI (non-contrast) and shoulder examination are performed. Informed consent is signed through Patient IQ, and surgery is scheduled within 21 days of consent.

1. Diagnostic arthroscopy to evaluate pathology
2. Arthroscopic augmented RCR using the CuffMend™ system
3. Office follow-ups at:
   • 1 week
   • 6 weeks
   • 12 weeks
   • 24 weeks
   • 52 weeks (with MRI at the same visit)
   • 102 weeks (with MRI at the same visit)

Study Overview

A prospective, multicenter cohort study establishing a registry to analyze the cellular and immunoregulatory profile of platelet-rich plasma preparations used to treat knee osteoarthritis.

Sponsor

Lead site Mayo Clinic; Principal Investigator Dr. Cole. Funded by the Rush Department of Orthopedics. (N=80)

Research Type

Prospective, multi-center cohort registry study

Candidate Criteria

Adults age 18 or older at the time of consent with a diagnosis of osteoarthritis (Kellgren Lawrence grade 1 to 4) who have chosen elective PRP therapy.

Purpose

To characterize the cell and immunoregulatory factor profile in PRP preparations, and in synovial fluid when effusion is present, and to correlate these findings to patient-reported pain and function outcomes.

Study Design

Patients receive an elective PRP injection at their baseline clinic visit using the Arthrex ACP kit. The study combines retrospective chart abstraction with prospective patient-reported outcomes, including KOOS, PROMIS Pain Interference, PROMIS Physical Function, SANE, VAS, and Tegner scores.

Study Procedures

1. Baseline clinic visit: elective PRP injection
2. Retrospective chart abstraction
3. Patient-reported outcomes sent through Patient IQ at:
   • Baseline
   • 6 weeks
   • 3 months
   • 6 months
   • 12 months
   • 24 months

Study Overview

Evaluation of the MISHA® Knee System for Symptom Relief in Subjects with Medial Knee Osteoarthritis versus Non Surgical Treatment: Randomized Assessment and Comparison of Therapies for Medial Knee Osteoarthritis

Sponsor

Rush University Medical Center, Department of Orthopedic Surgery. Industry sponsor: Moximed.

Research Type

Prospective, multicenter, two-arm, 2:1 randomized controlled trial

Enrollment

9 enrolled, actively enrolling.

Candidate Criteria

Male or female patients with medial compartment knee osteoarthritis and knee pain who have failed non-surgical treatment and are unwilling or ineligible for total knee replacement.

Purpose

To compare symptom relief and functional outcomes in patients with medial knee osteoarthritis treated with the MISHA Knee System versus non-surgical treatment.

Study Design

A prospective randomized clinical study comparing MISHA Knee System implantation to non-surgical treatment. Subjects in the non-surgical arm may cross over to MISHA after completing the six-month endpoint visit, and before the twenty-four-month visit.

Study Procedures

Baseline assessment and confirmation of eligibility, followed by randomization and follow-up assessments. Outcomes tracked include WOMAC pain, WOMAC function, subject activity, range of motion, radiographic implant integrity, adverse events, and subsequent surgical interventions.

1. Baseline evaluation and confirmation of eligibility
2. Randomization to one of two arms:
   • MISHA Knee System arm
   • Non-surgical treatment arm
3. Office follow-ups at:
   • 6 weeks
   • 3 months
   • 6 months
   • 12 months
   • 24 months
4. Crossover subjects restart the same follow up schedule after MISHA implantation

Study Overview

Bio Integrative, Fiber Reinforced Kneebar for Treating Subchondral Insufficiency of the Knee

Sponsor

Rush University Medical Center, Department of Orthopedic Surgery

Research Type

Prospective Case Series

Candidate Criteria

Patients undergoing knee surgery with the OSSIOfiber® nail who have a meniscal tear, loose body, unstable cartilage, or mechanical symptoms.

Purpose

To evaluate the utility of implanting biointegrative cannulated nails, organized in a rafter like formation within the tibia or femoral cortex, for managing overload associated with meniscal or chondral deficiency, comparing baseline and postoperative KOOS Pain scores.

Study Design

A single-center, open-label case series with a six-month minimum follow-up. Two cohorts are enrolled: Group 1 preoperatively and Group 2 postoperatively. Patient-reported outcomes are collected preoperatively, and at three months and six months postoperatively.

Study Procedures

Preoperative knee evaluation and MRI are performed. Informed consent is signed through Patient IQ, up to three months post op.

1. Knee arthroscopy to evaluate pathology
2. Arthroscopic knee repair using the OSSIOfiber® nail in a rafter configuration
3. Office follow-ups at:
   • 1 week (Group 1 only)
   • 3 months (X-ray at visit)
   • 6 months (non-contrast MRI at visit)

Study Overview

A prospective, single-center trial comparing the ROAM OA Single Upright brace to the Össur Unloader One brace for patients with medial compartment knee osteoarthritis, conducted through the Rush Motion Analysis Lab.

Sponsor

Enovis

Research Type

Prospective, single-center comparative trial (N=30)

Candidate Criteria

Adults ages 40 to 85 with a BMI under 35 and medial compartment knee osteoarthritis, with walking pain of at least 4 out of 10 at screening. Candidates must be able to walk unaided and independently for at least 20 minutes and be willing to wear a brace daily for the study duration. Full inclusion and exclusion criteria apply, including limits on recent injections, pain medication use, and other lower extremity conditions.

Purpose

To compare knee adduction moment during gait using the ROAM OA brace versus the Össur Unloader One brace, and to evaluate the long-term efficacy of the ROAM OA brace on pain and function over eight weeks.

Study Design

Patients complete a baseline gait analysis without a brace and with both braces. They are then split into two groups for eight weeks: Group A wears the ROAM OA brace daily at home, while Group B continues standard osteoarthritis care without a brace.

Study Procedures

1. Visit 1 (Baseline): Gait analysis without a brace, then with each brace
2. Weeks 1 through 8: Group A wears the ROAM OA brace daily; Group B receives standard care
3. Visit 2 (Week 4): Gait analysis and questionnaires, with Group A tested wearing the brace and Group B tested without
4. Visit 3 (Week 8, final): Gait analysis and questionnaires, with Group A tested both with and without the brace, and Group B tested without