Evaluation of the Medial Parapatellar Knee Injection Technique

This study has been completed.
Sponsor:
Information provided by:
Oklahoma State University Center for Health Sciences
ClinicalTrials.gov Identifier:
NCT00712972
First received: July 8, 2008
Last updated: July 16, 2009
Last verified: July 2009
  Purpose

The goal of our study is to present important anatomic considerations which should be considered before knee injection is performed. Additionally, we have developed important procedural augments to the traditional para-patellar injection techniques in order to exceed the accuracy and safety previously reported for the infra-patellar approaches We have developed an injection technique which mechanically is similar to current techniques practiced and poses no additional risks or discomfort to the patient. The basis of our technique and its success is through recognition of anatomic factors and avoidance of possible iatrogenic injuries which exist when using other knee injection technique. The focus of our study is to validate the clinical accuracy we have been obtaining using our technique through fluoroscopically confirmed visualized confirmation of repeated intra-articular deposit. Additionally we want to document the range of needle length we require to properly access the knee joint in our population to substantiate the importance of needle length. Needle length is a critical factor in obese patients whom have larger infra-patellar fat pads.

Our hypothesis is that when using a 6 inch 22 gage needle for intra-articular knee injections through the medial joint line approach, while utilizing the medial wall of the lateral femoral condyle as an intra-articular stop point for needle insertion, the accuracy of intra-articular deposit will exceed the values currently reported in the literature which is approximately 75% success rate.

To prove this point we will be injecting 2 cc of radiocontrast dye into the joint space and than immediatly view the joint flouroscopicly after the knee has been brought through 10 cycles of flexion and extension.


Condition
Osteoarthritis
Accuracy of Intraarticular Needle Placement

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of the Effectiveness of the Medial Parapatellar Knee Injection Technique

Resource links provided by NLM:


Further study details as provided by Oklahoma State University Center for Health Sciences:

Primary Outcome Measures:
  • The percentage of successfull intra-articular deposits of radiocontrast dye into the knee joint using our medial parapatellar joint line approach and comparison of this value to previously reported values in the literature [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The length of the needle which is required to successfully transverse the infrapatellar fat pad in order to deposit injectate into the knee joint [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: July 2008
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
1

Patients enrolled in this study are those whom present to our institution for elective knee arthroscopy. All patients scheduled to receive a knee arthroscopy scheduled through the office of Dr. Harold Battenfield will be asked to participate in the study on the day of their procedure as long as they do not fall into one of the exclusion criteria categories.

Patients will not be allowed to participate in this study if they have an allergy to iodine or shell fish, if they have a knee effusion diagnosed clinically on the day of surgery, if the knee or surrounding tissues display cellulitis or other signs of infection, or if the patient has had a traumatic accident to their knee which significantly changes its anatomical relationships


  Show Detailed Description

  Eligibility

Ages Eligible for Study:   5 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Patients enrolled in this study are those whom present to our institution for elective knee arthroscopy. All patients scheduled to receive a knee arthroscopy scheduled through the office of Dr. Harold Battenfield will be asked to participate in the study on the day of their procedure as long as they do not fall into one of the exclusion criteria categories.

The patient population often encountered in our practice includes a variety of patient demographics. We enjoy patient referrals from numerous primary care physicians in the community as well as through Oklahoma State University Medical Center's emergency department. Additionally we work closely with one of the regions primary workers compensation agencies. Because of our numerous referral resources, our patient population is considerably varied and provides an ample mixture of patient demographics to allow us to reasonably extrapolate and compare our study results to the general population

Criteria

Inclusion Criteria:

  • Patients enrolled in this study are those whom present to our institution for elective knee arthroscopy. All patients scheduled to receive a knee arthroscopy scheduled through the office of Dr. Harold Battenfield will be asked to participate in the study on the day of their procedure as long as they do not fall into one of the exclusion criteria categories

Exclusion Criteria:

  • Patients will not be allowed to participate in this study if they have an allergy to iodine or shell fish, if they have a knee effusion diagnosed clinically on the day of surgery, if the knee or surrounding tissues display cellulitis or other signs of infection, or if the patient has had a traumatic accident to their knee which significantly changes its anatomical relationships
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00712972

Locations
United States, Oklahoma
Oklahoma State University Collage of Health Sciences
Tulsa, Oklahoma, United States, 74107
Sponsors and Collaborators
Oklahoma State University Center for Health Sciences
Investigators
Principal Investigator: Harold L Battenfield, D.O. Oklahoma State University
  More Information

Publications:
Responsible Party: Harold L Battenfield / Dr., Oklahoma State University
ClinicalTrials.gov Identifier: NCT00712972     History of Changes
Other Study ID Numbers: IRB#200808
Study First Received: July 8, 2008
Last Updated: July 16, 2009
Health Authority: United States: Institutional Reveiw Board

Keywords provided by Oklahoma State University Center for Health Sciences:
knee injection
parapatellar

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on August 20, 2014