Effects of Osteotomies Around the Knee on Cartilage Glycosaminoglycan Content Using dGEMRIC Non-invasive Imaging

NCT01269944 | Completed DMC

• 1 other identifier: dGEMRIC HTO
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Medial compartment osteoarthritis of the knee is commonly treated by a surgical intervention called 'high tibial osteotomy' (VTO). Although it has repeatedly been shown that pain improves following this procedure, it is unknown how cartilage quality is affected by the procedure. In this study, a recently developed MRI technique is used to evaluate changes in cartilage quality before and after the surgery. Changes in MRI signals are correlated to subjective improvements (score lists). 10 patients participate in this study. Approval has been granted by the Medical Ethical Committee of the University Medical Center Utrecht. All participants are required to give informed consent before participation.

Conditions

Medial Compartment Osteoarthritis of the Knee

Keywords

osteoarthritis; knee; high wedge tibial osteotomy; dGEMRIC

Outcome Measures

Primary Outcomes (1)

• MRI T1 signal, change from baseline

  MRI T1 signal is deducted from dGEMRIC measurements

  Change from baseline 9 months after surgery (HTO)

Secondary Outcomes (1)

• KOOS clinical score, change from baseline

  Change from baseline 9 months after surgery (HTO)

Study Arms (1)

Medial compartment knee osteoarthritis

Patients with medial compartment osteoarthritis of the knee, as proven by x-rays and clinical examination

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients above 18 years with osteoarthritis of the knee and a future planned osteotomy of the tibia or femur are eligible for participation in this study.

You may qualify if:

• Both males and females
• Patients \>18 years old
• Indication as set by treating physician for operative procedure around the knee: HTO (high tibial osteotomy), femoral osteotomy
• Patient informed consent signed Note: Patients with previous surgery, history of intra-articular medication, meniscectomy or ACL lesions can be included in this study.

You may not qualify if:

• The following patients are excluded from participating in this study:
• Known anaphylactic reactions to Gadolinium or related substances
• Kidney diseases with a creatinin excretion of \< 20 ml/min
• Risk groups for MRI scanning due to magnetic field or contrast agent (9, 10): Metal in body: Pacemaker / AICD / ICD (coronary defibrillator), Nervus vagus (X) stimulator, Artificial heart valve (depending on type), Metal clips on cerebral arteries or veins, Metal particles in eye, Port-a-cath, Metal stents, Hydrocephalic pump / insuline pump, Metal implants; f/e screws, prostheses, piercings.
• Claustrofibia
• First three months of pregnancy (not sufficient information available about effects of contrast agent on foetal development in this stage). Patients will be asked if they may be pregnant (\< 3 months of pregnancy): if uncertain, they will be excluded.
• Contra-indications for MRI scanning, as well as contra-indications to intra-venous administration of contrast agents were discussed with Ms. Shanta Kalaykhan-Sewradj, head of MRI technicians in the UMC Utrecht. For further information, the booklet 'Bijwerkingen van contrastmiddelen: de gadoliniumverbindingen' by Esther Ensing and Janet Hoven was used (Published by Nederlandse Vereniging voor Slachtoffers van Medische Contrastmiddelen, 2004).

Sponsors & Collaborators

• UMC Utrecht: lead

Study Sites (1)

University Medical Center Utrecht

Utrecht, 3584 CX, Netherlands

Location

Related Publications (3)

• Burstein D. Tracking longitudinal changes in knee degeneration and repair. J Bone Joint Surg Am. 2009 Feb;91 Suppl 1:51-3. doi: 10.2106/JBJS.H.01412.

  PMID: 19182025 BACKGROUND

• Brouwer RW, Bierma-Zeinstra SM, van Koeveringe AJ, Verhaar JA. Patellar height and the inclination of the tibial plateau after high tibial osteotomy. The open versus the closed-wedge technique. J Bone Joint Surg Br. 2005 Sep;87(9):1227-32. doi: 10.1302/0301-620X.87B9.15972.

  PMID: 16129748 BACKGROUND

• Rutgers M, Bartels LW, Tsuchida AI, Castelein RM, Dhert WJ, Vincken KL, van Heerwaarden RJ, Saris DB. dGEMRIC as a tool for measuring changes in cartilage quality following high tibial osteotomy: a feasibility study. Osteoarthritis Cartilage. 2012 Oct;20(10):1134-41. doi: 10.1016/j.joca.2012.07.001. Epub 2012 Jul 10.

  PMID: 22796509 DERIVED

Related Links

• Affiliation site

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Daniel B Saris, MD, PhD

  University Medical Center Utrecht, the Netherlands

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr.

Study Record Dates

• First Submitted: December 29, 2010
• First Posted: January 4, 2011
• Study Start: July 1, 2007
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: November 6, 2017

Record last verified: 2017-11

Locations

NL (1)