Mini Stem DEXA (Dual Energy X-ray Absorptiometry)

NCT01066936 | Completed Results

• 1 other identifier: 2090SMFH131
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to evaluate the bone ingrowth after implantation of the study device. This study will also document any device-related surgical complications or adverse radiographic observations. Improvement in pain, function, and health economic data will be compared with improvements documented with other joint systems.

Conditions

Osteoarthritis, Hip

Outcome Measures

Primary Outcomes (5)

• DEXA Analysis of BMD at Preoperative Visit

  DEXA=Dual Energy X-Ray Absorptiometry; BMD=Bone Mineral Density; The proximal femur was divided into 7 regions relative to the length of the stem. Lateral portions = region 1, region 2 and region 3; The entire bone mass immediately distal to the stem tip = region 4; Medial portions = region 5, region 6, and region 7. Mean BMD was calculated for each femoral region. BMD values were adjusted peri-prosthetically to account for stem area.

  Preoperative

• DEXA Analysis of BMD at 3 Months

  DEXA=Dual Energy X-Ray Absorptiometry; BMD=Bone Mineral Density; The proximal femur was divided into 7 regions relative to the length of the stem. Lateral portions = region 1, region 2 and region 3; The entire bone mass immediately distal to the stem tip = region 4; Medial portions = region 5, region 6, and region 7. Mean BMD was calculated for each femoral region. BMD values were adjusted peri-prosthetically to account for stem area.

  3 Months

• DEXA Analysis of BMD at 6 Months

  DEXA=Dual Energy X-Ray Absorptiometry; BMD=Bone Mineral Density; The proximal femur was divided into 7 regions relative to the length of the stem. Lateral portions = region 1, region 2 and region 3; The entire bone mass immediately distal to the stem tip = region 4; Medial portions = region 5, region 6, and region 7. Mean BMD was calculated for each femoral region. BMD values were adjusted peri-prosthetically to account for stem area.

  6 Months

• DEXA Analysis of BMD at 1 Year

  DEXA=Dual Energy X-Ray Absorptiometry; BMD=Bone Mineral Density; The proximal femur was divided into 7 regions relative to the length of the stem. Lateral portions = region 1, region 2 and region 3; The entire bone mass immediately distal to the stem tip = region 4; Medial portions = region 5, region 6, and region 7. Mean BMD was calculated for each femoral region. BMD values were adjusted peri-prosthetically to account for stem area.

  1 Year

• DEXA Analysis of BMD at 2 Years

  DEXA=Dual Energy X-Ray Absorptiometry; BMD=Bone Mineral Density; The proximal femur was divided into 7 regions relative to the length of the stem. Lateral portions = region 1, region 2 and region 3; The entire bone mass immediately distal to the stem tip = region 4; Medial portions = region 5, region 6, and region 7. Mean BMD was calculated for each femoral region. BMD values were adjusted peri-prosthetically to account for stem area.

  2 Year

Secondary Outcomes (24)

• Baseline Harris Hip Score (HHS) at Preoperative Visit

  Preoperative

• Harris Hip Score (HHS) at 3 Month Visit

  3 Month

• Harris Hip Score (HHS) at 6 Month Visit

  6 Months

• Harris Hip Score (HHS) at 1 Year Visit

  1 Year

• Harris Hip Score (HHS) at 2 Year Visit

  2 Years

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The purpose of this investigation is to assess the bone growth after implantation with a modular, short hip stem using Dual Energy X-ray Absorptiometry (DEXA). The intended use of this product is for patients with non-inflammatory and inflammatory degenerative joint disease who require a total hip replacement.

You may qualify if:

• Patient has hip disease that requires a total hip arthroplasty.
• Patient is willing to consent to participate in the study.
• Patient plans to be available for the study duration.
• Patient is in stable health and is free of or treated and stabilized for cardiac, pulmonary, hematological, or other conditions that would pose excessive operative risk.

You may not qualify if:

• Patient known to have insufficient bone stock.
• Patient has had major non-arthroscopic surgery to the study hip.
• Patient has physical, emotional or neurological conditions that would compromise the patient's compliance with postoperative rehabilitation and follow-up.
• Patient has a known sensitivity to materials in the device.

Sponsors & Collaborators

• Smith & Nephew, Inc.: lead

Study Sites (1)

Malabar Orthopaedic Clinic

Windsor, 3181, Australia

Location

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Limitations and Caveats

There was a decreased compliance rate at the 3 year follow-up and a 50% termination rate by the 5 year follow-up resulting in a much smaller sample sizes for data collection.

Results Point of Contact

• Title: Tracey Brengola
• Organization: Smith & Nephew

tracey.brengola@smith-nephew.com

978-319-2702

Study Officials

• Steve McMahon, MD

  Malabar Orthopaedic Clinic

  PRINCIPAL INVESTIGATOR

• Beate Hanson, MD, PhD

  Vice Presidient, Global Clinical Strategy

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2010
• First Posted: February 10, 2010
• Study Start: September 14, 2009
• Primary Completion: April 18, 2016
• Study Completion: April 18, 2016
• Last Updated: March 6, 2020
• Results First Posted: March 6, 2020

Record last verified: 2020-02

Locations

AU (1)