Early Weight-Bearing After Lapidus Arthrodesis

NCT03257540 | Terminated FDA Device

• 1 other identifier: P30-SP-0001
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 3

Brief Summary

The goal of this research study is to determine if union rates are affected by early weight-bearing after Lapidus Arthrodesis using the Phantom™ Intramedullary Nail. The study hypothesis is that the union rate for those who undergo a Lapidus Arthrodesis procedure with the Phantom™ Intramedullary Nail and participate in an early weight-bearing protocol will be non-inferior to union rates previously published for this procedure.

Conditions

Arthrodesis; Bunion; Hallux Valgus

Keywords

bunion; early weight-bearing; Lapidus; arthrodesis; intramedullary nail; Hallux Valgus

Outcome Measures

Primary Outcomes (1)

• Clinical/radiographic healing

  Evaluate clinical/radiographic healing (union vs. non-union) after a Lapidus arthrodesis procedure at 6 months following a surgery using the Phantom Intramedullary nail with early weightbearing at 2 weeks.

  6 months

Secondary Outcomes (11)

• Clinical complications

  24 Months

• Time to full weight-bearing

  0 to 12 months

• Change in radiographic angular/positional alignment before and after the Lapidus procedure

  Pre-operatively, 2 Weeks, 6 Weeks, 12 Weeks, 6 Months, 12 Months, 24 Months

• Change in VAS Pain Score across multiple time points

  Pre-operatively, 2 Weeks, 6 Weeks, 12 Weeks, 6 Months, 12 Months, 24 Months

• Change in AOFAS Forefoot/Hallux Valgus Score across multiple time points

  Pre-operatively, 2 Weeks, 6 Weeks, 12 Weeks, 6 Months, 12 Months, 24 Months

Study Arms (1)

Small Bone Intramedullary Nail

All study participants

Device: Small Bone Intramedullary Nail

Interventions

Small Bone Intramedullary Nail DEVICE

Patients undergoing a Lapidus Arthrodesis procedure for hallux valgus correction who are receiving a Phantom Small Bone Intramedullary nail will begin weight-bearing at 2 weeks and follow a pre-determined post-operative protocol.

Also known as: Phantom Small Bone Intramedullary Nail - Lapidus

Small Bone Intramedullary Nail

Eligibility Criteria

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

Study Population

The study population will consist of adults age 18 and older with a painful bunion deformity. The most common age demographic to have surgery for hallux valgus correction is age 50-59. Additionally, the prevalence of hallux valgus in females is greater than males, so a higher percentage of female subjects seeking treatment is likely to be expected. This population is suitable for the purpose of the investigation, as groups most likely to seek treatment (surgical) for hallux valgus correction will be represented in this study.

You may qualify if:

• The subject is at least 18 years of age with closed physeal plates at the time of screening.
• The intermetatarsal angle is greater than or equal to 10 degrees.
• The hallux valgus angle is greater than or equal to 25 degrees.
• The subject has foot pain/discomfort on the foot in question.
• The subject has activity limitations due to the foot in question.
• The subject agrees to comply with the requirements of the study and complete the study measures.
• The subject is willing and able to provide written informed consent.

You may not qualify if:

• The subject is pregnant.
• The subject is a current smoker.
• The subject has been clinically diagnosed with diabetes.
• The subject has been clinically diagnosed with peripheral neuropathy.
• The subject had been previously sensitized to titanium.
• The subject currently takes oral steroids or rheumatoid biologics.
• The subject has had previous surgery for hallux valgus on operative side.
• The subject has insufficient quantity or quality of bone to permit stabilization, conditions that retard healing (not including pathological fractures) and conditions causing poor blood supply such as peripheral vascular disease.
• The subject has a history of delayed or non-union for fracture or joint.
• The subject has an active, suspected or latent infection in the affected area.
• The subject will require a structural graft in the 1st TMT joint.
• The subject is scheduled to undergo a concomitant 2nd tarsometatarsal joint arthrodesis procedure.
• The subject is scheduled to undergo a same-day bilateral procedure.
• The subject cannot be scheduled for surgery within 3 months of the pre-operative exam.
• The subject has previously been enrolled into this study for a contralateral procedure.

Sponsors & Collaborators

• Paragon 28: lead

Study Sites (3)

Redwood Orthopaedic Surgery Associates

Santa Rosa, California, 95403, United States

Location

Orthopaedic & Spine Center of the Rockies

Fort Collins, Colorado, 80525, United States

Location

Orthopedic Center of Palm Beach County

Atlantis, Florida, 33462, United States

Location

Related Publications (1)

• Casaburi R, Porszasz J, Hecht A, Tiep B, Albert RK, Anthonisen NR, Bailey WC, Connett JE, Cooper JA Jr, Criner GJ, Curtis J, Dransfield M, Lazarus SC, Make B, Martinez FJ, McEvoy C, Niewoehner DE, Reilly JJ, Scanlon P, Scharf SM, Sciurba FC, Woodruff P; COPD Clinical Research Network. Influence of lightweight ambulatory oxygen on oxygen use and activity patterns of COPD patients receiving long-term oxygen therapy. COPD. 2012 Feb;9(1):3-11. doi: 10.3109/15412555.2011.630048.

  PMID: 22292592 DERIVED

MeSH Terms

Conditions

Ankylosis; Bunion; Hallux Valgus

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Foot Deformities, Acquired; Foot Deformities

Study Design

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

Study Record Dates

• First Submitted: August 18, 2017
• First Posted: August 22, 2017
• Study Start: October 31, 2017
• Primary Completion: August 31, 2018
• Study Completion: August 31, 2018
• Last Updated: October 17, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)