Prospective Observational Case Series of Primary Hip Arthroplasty With a Short Cemented Stem (Friendly Short)

NCT04987437 | Completed

• 1 other identifier: H-02
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Post-marketing observational case series to analyse the functional recover and radiographic outcomes in terms of implant stability and survivorship of primary hip arthroplasty with Friendly short cemented stem.

Conditions

Total Hip Arthroplasty

Outcome Measures

Primary Outcomes (3)

• change in percentage of the results of the absolute and weighted (age, gender) Harris Hip Score score from baseline to 1 year

  up to 5 years FU

• Change in percentage of the results of the Oxford Hip Score baseline to 1 year

  up to 5 years FU

• Change in Range Of Motion from baseline to 1 year.

  up to 5 years FU

Secondary Outcomes (3)

• Radiographic stability

  up to 5 years FU

• Rate of failure

  up to 5 years FU

• Any possible adverse event or complication

  up to 5 years FU

Interventions

Friendly short stem DEVICE

Total Hip Arthroplasty with Friendly Short stem

Eligibility Criteria

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

Study Population

Patients requiring a primary hip arthroplasty, due to primary and secondary coxarthrosis, avascular necrosis, rheumatoid arthritis, neck (but not diaphyseal) fractures

You may qualify if:

• Patients of both genders;
• Patients of all ages, but \> 18 years old;
• Patients with primary and secondary coxarthrosis;
• Patients with rheumatoid arthritis;
• Patients with avascular necrosis;
• Patients with neck (not diaphyseal) fractures;
• Patients requiring a primary hip arthroplasty.

You may not qualify if:

• Patients requiring a revision of a previous stem;
• Patients with proven active or suspicious infections;
• Patients with known hypersensitivity to used materials;
• Patients with known active neoplastic or metastatic diseases;
• Patients with significant neurological or musculoskeletal disorders that may affect functional recover;
• Patients with proven haemophilic disease;
• Patients with unwilling or unable to comply with rehabilitation or inability to return for follow-up visits;
• Women with pregnancy or childbearing capacity or breast-feeding;
• Subjects already enrolled in other clinical trials.

Sponsors & Collaborators

• Limacorporate S.p.a: lead

Study Sites (1)

Istituto Clinico Sant'Anna

Brescia, 25127, Italy

Location

Related Publications (1)

• Marega L, Gnagni P, Marega C, Marega F. Mid-term outcomes after primary total hip arthroplasty with a cemented short stem in an elderly patient cohort. Arch Orthop Trauma Surg. 2024 Dec 27;145(1):96. doi: 10.1007/s00402-024-05734-3.

  PMID: 39729135 DERIVED

Study Design

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

Study Record Dates

• First Submitted: July 27, 2021
• First Posted: August 3, 2021
• Study Start: May 2, 2011
• Primary Completion: December 6, 2013
• Study Completion: November 6, 2018
• Last Updated: August 3, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)