Arthroscopic debridement with stem cell transplantation for Arthrosis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
UC Health Steadman Hawkins Clinic - Denver Inverness, Denver, CO
Arthrosis+2 More
Arthroscopic debridement with stem cell transplantation - Procedure
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

The Effect of Adipose-Derived Stem Cells for Knee Osteoarthritis

See full description

Eligible Conditions

  • Arthrosis
  • Osteoarthritis of the Knee

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Arthroscopic debridement with stem cell transplantation will improve 1 primary outcome, 3 secondary outcomes, and 1 other outcome in patients with Arthrosis. Measurement will happen over the course of The study will end after 24 month follow-up is completed in all participants..

1, 12, 24 months
MRI scans -
6, 12, 24 months
Lysholm score
Tegner score
VR-12
Month 24
Postoperative KOOS (Knee Injury and Osteoarthritis Outcome Score) score 24 months following surgery

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Placebo
1 of 2
Stem Cells
1 of 2
Active Control
Experimental Treatment

This trial requires 29 total participants across 2 different treatment groups

This trial involves 2 different treatments. Arthroscopic Debridement With Stem Cell Transplantation is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Stem Cells
Procedure
Fat pad harvest with stem cell transplantation and standard arthroscopic debridement.
Placebo
Procedure
Standard arthroscopic debridement with fat pad harvest WITHOUT stem cell transplantation

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6, 12, 24 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 6, 12, 24 months for reporting.

Closest Location

UC Health Steadman Hawkins Clinic - Denver Inverness - Denver, CO

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Meniscal debridement or partial menisectomy
Age between 35 and 70 years-old
Meniscal repair that does not necessitate a different postoperative protocol from meniscal debridement or partial menisectomy
Removal of loose bodies
Chondroplasty
Synovectomy
Soft tissue releases for flexion or extension contracture.
Diagnosis of pre-existing mild to moderate osteoarthritis of the medial or lateral femoral condyle (Kellgren-Lawrence Grade 2 or 3)
< 6 months of knee pain or < 6 months of a significant exacerbation of existing knee pain
Physical examination findings consistent with the proposed surgical procedure.

Patient Q&A Section

What causes arthrosis?

"There is no one single cause of arthrosis. However, trauma, and/or inflammation may trigger the disorder. Other factors such as osteogenesis defect, endocrine disorders and autoimmune disorders may also cause arthrosis." - Anonymous Online Contributor

Unverified Answer

Can arthrosis be cured?

"Data from a recent study of the present study fail to support the notion that arthrosis is a static disease which can be cured by the manipulation of the underlying arthritic lesions. In our study, no benefit of the joint lavage/mobilization procedure was demonstrated over conservative management for arthrosis." - Anonymous Online Contributor

Unverified Answer

What are common treatments for arthrosis?

"Results from a recent paper shows that the number of different treatment options can be large. Because of this a multidisciplinary approach is suggested to ensure that the optimal treatment is chosen based on the individual case of each patient." - Anonymous Online Contributor

Unverified Answer

What are the signs of arthrosis?

"Arthrosis can exhibit as redness, swelling or decreased range of motion and be associated with difficulty moving joints. This can manifest as loss of sleep, lethargy, joint pains, low energy level or low activity level and a high propensity for irritability and depression. There have been reported cases where the arthritis has been aggravated due to use of drugs. It can also be caused by long-term high amounts of trauma associated with ageing. However, arthritis is the most common cause of pain in older adults.\n\nThe most common signs of heart disease are chest pain or discomfort when exercising, shortness of breath or faintness." - Anonymous Online Contributor

Unverified Answer

What is arthrosis?

"Arthrosis can affect any joint over a long time. It is a change in the shape of the bones of the joint, or in the movement between them, which causes pain and stiffness. Any bone in a joint that is no longer performing its usual role can become affected. Symptoms and signs include pain, swelling, and stiffness.\n" - Anonymous Online Contributor

Unverified Answer

How many people get arthrosis a year in the United States?

"Compared with arthrosis with inflammation, arthrosis without inflammation is more common in men and people in the 30-49 age group. A large proportion of the cases of arthrosis without inflammation occur in the foot, hand, and ankle areas. The number of cases of arthrosis is large and growing every year. The US PPRC was created in order to understand and to report disease status in the US, whereas data from other countries are needed to evaluate strategies for disease prevention." - Anonymous Online Contributor

Unverified Answer

Does arthroscopic debridement with stem cell transplantation improve quality of life for those with arthrosis?

"Results from a recent paper suggest that ARG should be performed in patients with active arthrosis, and that stem cell transplantation with autologous chondrocytes may reduce pain and improve quality of life." - Anonymous Online Contributor

Unverified Answer

Is arthroscopic debridement with stem cell transplantation typically used in combination with any other treatments?

"This technique could be used as a standard treatment because it can improve pain and function, reduce swelling and limit stiffness. A small series with limited follow-up was the study's limitations." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving arthroscopic debridement with stem cell transplantation?

"There are not enough reports concerning studies of ACLM and arthroscopic surgical procedure involving stem cell transplantation. Because arthroscopic debridement with stem cell transplantation technique, which used to be accepted as a promising technique to promote regeneration of ACLM, can effectively improve the joint function and reduce pain when performing ACLM, there is a more efficient and promising method for ACLM treatment." - Anonymous Online Contributor

Unverified Answer

How serious can arthrosis be?

"Many conditions can be associated with arthritis and arthrosis. Arthrosis is not always debilitating or debilitating, and with proper treatment, many of the symptoms can be managed." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating arthrosis?

"No new arthrosis discoveries have been made in the past 20 years. The treatments were modified and optimized recently, and may change at any time. Further, a different definition of what constitutes arthrosis is proposed, so different treatments will be needed. More studies are needed to define the exact cause of arthrosis." - Anonymous Online Contributor

Unverified Answer

Has arthroscopic debridement with stem cell transplantation proven to be more effective than a placebo?

"After long-term follow-up in the present study, patients with osteonecrosis of the femoral head treated with arthroscopic debridement and autogenous marrow stem cell transplantation showed improved function and reduced deformity. This group also had significantly improved symptoms when compared to patients who received a placebo. Arthroscopic debridement with autologous marrow stem cell transplantation deserves further study, especially for young and active patients with no contraindications." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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