Project JAY HAP Registration Study

NCT02347397 | Completed

• 1 other identifier: 14-4561-01
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 5

Brief Summary

This is a prospective, randomized, multicenter clinical study in elderly Chinese subjects to compare the safety and efficacy of the SS Bipolar Head and SL-TWIN Stem with Bipolar Head and SL-PLUS Stem in hemiarthroplasty of the hip

Conditions

Femoral Neck Fractures

Outcome Measures

Primary Outcomes (1)

• Harris Hip Score

  1 year post-operative

Secondary Outcomes (1)

• Composite Clinical Success, as indicated by A) No revision of any device component; and B) Total Harris Hip Score greater than or equal to 80 (excellent to good score); and C) Radiologic success.

  1 year post-operative

Other Outcomes (3)

• Barthel Index

  1 year post-operative

• SF-12 Health Survey

  1 year post-operative

• Number of adverse events

  Up to 1 year post-operative

Study Arms (2)

SS Bipolar Head + SL-TWIN Stem

EXPERIMENTAL

Subject will be implanted with the SS Bipolar Head \& SL-TWIN Stem

Device: SS Bipolar Head + SL-TWIN Stem

Bipolar Head + SL-PLUS Stem

ACTIVE COMPARATOR

Subject will be implanted with the Bipolar Head \& SL-PLUS Stem

Device: Bipolar Head + SL-PLUS Stem

Interventions

SS Bipolar Head + SL-TWIN Stem DEVICE

Subject will undergo hemiarthroplasty surgery with SS Bipolar Head \& SL-TWIN Stem

SS Bipolar Head + SL-TWIN Stem

Bipolar Head + SL-PLUS Stem DEVICE

Subject will undergo hemiarthroplasty surgery with Bipolar Head \& SL-PLUS Stem

Bipolar Head + SL-PLUS Stem

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Male or female subjects, aged between 65 and 90 years inclusive of Chinese ethnicity.
• Subject presents with femoral neck fracture (Garden Type II, III, or IV) requiring hemiarthroplasty of the hip.
• Subject is able to move independently before the fracture, with or without the use of walking aids .
• Subject who is able to give voluntary, written informed consent to participate in the study and from whom consent has been obtained by signing and dating an EC-approved consent form.
• Subject who is able to understand this clinical study, co-operates with the investigational procedures and is willing to return to the hospital for all the required post-operative follow-ups for up to 12 months.
• Life expectancy of subject is over 2 years.

You may not qualify if:

• Bilateral hip disease with the anticipated need for bilateral hip implant during study participation (i.e., within the next 12 months).
• Subject experienced prior joint replacement surgery on any major joint (hip, knee) in lower limb within the last 12 months.
• Subject has known or suspected metal sensitivity.
• Subject is known to have insufficient bone stock resulting from conditions such as cancer, significant osteoporosis or metabolic bone disorders, which cannot provide adequate support and/or fixation to the prosthesis.
• Subject is severely obese (BMI\>35).
• Subject is not suitable for hemiarthroplasty (i.e., inflammatory arthritis, pathological fractures, etc.)
• Subject had an active infection or sepsis (treated or untreated)
• Subject has conditions that may compromise implant stability or postoperative recovery (i.e., Paget's or Charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency, hip abduction muscle strength less than grade IV or complete loss, or neuromuscular disease).
• Subject has an emotional or neurological condition that would affect their ability or willingness to participate in the study (e.g. cognitive disorder, mental illness, mental retardation).
• Subject is immunosuppressed, has an autoimmune disorder, or an immunosuppressive disorder. For examples, subject is on immunosuppressive therapy (corticosteroid hormones in large amounts, cytotoxic drugs, antilymphocytic serum or irradiation in large doses) or has acquired immunodeficiency syndrome (AIDS).
• Subject is known to be at risk for lost to follow-up, or failure to return for scheduled visits.
• Subject was enrolled in another investigational drug, biologic, or device study in the last 12 months.
• Known alcohol and/or drug abuse

Sponsors & Collaborators

• Smith & Nephew Orthopaedics (Beijing) Limited: lead

Study Sites (5)

Haikou People's Hospital

Haikou, Hainan, 570208, China

Location

Luoyang Orthopedic-Traumatological Hospital

Luoyang, Henan, 471002, China

Location

Inner Mongolia Bao Gang Hospital

Baotou, Inner Mongolia, 014010, China

Location

The First Teaching Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, 830054, China

Location

Traditional Chinese Medicine Hospital of Xinjiang Uygur Autonomous Region

Ürümqi, Xinjiang, 830099, China

Location

MeSH Terms

Conditions

Femoral Neck Fractures

Condition Hierarchy (Ancestors)

Hip Fractures; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Li Cao

  First Affiliated Hospital of Xinjiang Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2015
• First Posted: January 27, 2015
• Study Start: April 29, 2015
• Primary Completion: October 16, 2017
• Study Completion: October 16, 2017
• Last Updated: March 2, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)