An RSA and DEXA Study on Migration of Proximal Interphalangeal (PIP) Joint Prostheses of the Hand

This study has been completed.
Sponsor:
Collaborators:
Aarhus University Hospital
Biomet, Inc.
Avanta
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00175188
First received: September 10, 2005
Last updated: October 12, 2010
Last verified: October 2010
  Purpose

The purpose of this study is to compare the early migration and the periprosthetic bone changes of cemented versus non-cemented interphalangeal implants using Roentgen stereophotogrammetric analysis and dual energy x-ray absorptiometry (DEXA). Furthermore, a thorough occupational therapist evaluation on the functional progress prior to and after surgery will be assessed.


Condition Intervention
Osteoarthritis
Device: Avanta (PIP joint implant with a titanium porous coating)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Roentgen Stereophotogrammetric Analysis and DEXA Study on Migration of Proximal Interphalangeal Joint Prostheses of the Hand. A Randomised Prospective Study of Cemented Versus Non-cemented Implants

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • PIP implant migration evaluated by RSA [ Time Frame: 2010 ] [ Designated as safety issue: Yes ]
  • Periprosthetic bone changes evaluated by DEXA [ Time Frame: 2010 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Changes in pain, grip strength, edema and range of motion [ Time Frame: 2010 ] [ Designated as safety issue: Yes ]

Enrollment: 30
Study Start Date: June 2004
Study Completion Date: October 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cemented PIP implant
Avanta PIP
Device: Avanta (PIP joint implant with a titanium porous coating)
Implant is inserted at the time of surgery, after written consent
Other Name: Avanta PIP implant, plasma-spray titanium coated
Active Comparator: Uncemented PIP implant
Avanta PIP
Device: Avanta (PIP joint implant with a titanium porous coating)
Implant is inserted at the time of surgery, after written consent
Other Name: Avanta PIP implant, plasma-spray titanium coated

Detailed Description:

There is a large patient group with primary osteoarthritis (OA) and secondary osteoarthritis due to joint-associated fractures, repeated trauma to the joint and surroundings, congenital joint-deformity, hyper mobility and diabetes. There are 2 preservative surgical treatment alternatives for PIP joint OA; namely arthrodesis and arthroplasty. Arthroplasty is the choice of treatment, when preserving motion is feasible, but patients can have excellent results with arthrodesis. There are several arthroplasty techniques including fibrous interposition, palmar plate advancement, metallic or metalloplastic hinges or one piece polymeric plastic hinge devices.

In this study, we use a 2 part metallic implant designed to minimize bone removal and preserve the collateral ligaments of the PIP joint providing a more stable joint particularly to imposed lateral forces. Preservation of the capsule with this prosthesis allows diversion of some of the transverse forces and axial torques from the prosthesis endosteal interface to the lateral cortices through the collateral ligaments. The semi-constrained design provides a more physiological articulation, and besides this the centered anatomical configuration allows a more reliable restoration of tendon movements to the joint. All of this probably diminishes the mechanical contribution to osteolysis and subsidence at the bone prosthesis interface and prolongs the time of survival of the prosthesis. All of these improvements on prosthetic design are very important and provide a better possibility for the patient to regain near-normal joint conditions.

The prosthesis has two components - one proximal and one distal. The proximal part has a symmetric shallow bicondylar anatomic configuration fixed on a stem for the intramedullary cavity of the proximal phalanx. The distal component is fabricated from polyethylene press-molded on a metal backing with a stem for the intramedullary cavity of the middle phalanx. Both implant parts are CoCr alloy with a coating of plasma sprayed porous titanium. Studies have shown that bone grows well into the titanium surface of experimental implants, but it is also fixed into bone using cement.

With the new type of PIP prostheses there is often excellent if not total long-term pain relief and little or no loss of movement. The stability becomes considerably better compared with older types of prostheses. The outcome is however dependant on the skill and experience of the surgeon.

The purpose of this study is to compare the early migration and the periprosthetic bone changes of cemented versus non-cemented interphalangeal implants. Furthermore a thorough occupational therapist evaluation on the functional progress prior to and after surgery will be assessed.

To evaluate both the implant-bone micromotions, metal markers have been placed on the implant preoperatively and other markers will be fixed in the phalangeal bone intra-operatively. This allows us to evaluate the implant micromotion with stereo x-rays by photogrammetric computer analyses called RSA at the Orthopaedic Center, Aarhus University Hospital. Follow-up stereo x-rays will be scheduled for 1 week, 6 weeks, 12 weeks, 6 months, 1 year and 2 years post-surgery. Periprosthetic bone density will be evaluated at 1 week, 1 year and 2 years upon inclusion at the Orthopaedic Center, Aarhus University Hospital. An occupational therapist will evaluate the joint range of motion, pain, edema and grip strength prior to surgery and throughout the 2 year follow up.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with osteoarthrosis of the PIP joints.
  • Patients with sufficient bone quality for implantation of a non-cemented prosthesis. This is estimated by the surgeon preoperatively.
  • Informed written patient consent.
  • Patients must read and understand Danish.

Exclusion Criteria:

  • Patients with neuromuscular or vascular diseases in the affected upper extremity.
  • Patients who, preoperatively, are found to have unsuitable bone quality for un-cemented arthroplasty fixation, for instance bone cysts not visible on x-ray.
  • Patients who cannot refrain from taking non-steroidal anti-inflammatory drugs (NSAIDs) postoperatively including cox-2 inhibitors.
  • Patients with previously diagnosed osteoporosis.
  • Women who are pregnant or are at risk of getting pregnant during the time of investigation.
  • Patients with rheumatoid arthritis.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00175188

Locations
Denmark
Orthopaedic Center, Aarhus University Hospital
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital
Biomet, Inc.
Avanta
Investigators
Principal Investigator: Kjeld Søballe, MD, Prof. Orthopaedic Center, Aarhus University Hospital
  More Information

No publications provided

Responsible Party: Professor Kjeld Soballe, Aarhus University Hospital, Tage-Hansens Gade 2, 8000 Aarhus C
ClinicalTrials.gov Identifier: NCT00175188     History of Changes
Other Study ID Numbers: 20030240
Study First Received: September 10, 2005
Last Updated: October 12, 2010
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:
RSA
DEXA
Osteoarthritis
Finger implant
Micromotion
Bone density
Cement

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

ClinicalTrials.gov processed this record on October 16, 2014