Long-term Outcomes of Conical Tapered Stems in Cementless Total Hip Arthroplasty Due to Congenital Hip Pathologies

NCT04748458 | Completed Results DMC

• 1 other identifier: 589/2020/Oss/IOR
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

A retrospective consecutive population of patients treated with conical tapered stems in cementless total hip arthroplasty for osteoarthritis due to congenital hip pathologies will be selected. The aim of this retrospective study is to evaluate the long-term clinical and radiographic results of this implant and the survival rates in such a specific cohort.

Conditions

Dysplasia; Hip; Prosthesis Survival

Outcome Measures

Primary Outcomes (4)

• Harris Hip Score

  Mean clinical results at last follow-up evaluated using the Harris hip score. Minimum-maximum values: 0-100. Best result: 100.

  15 months

• Survival Rate

  Percentage of survived implants (no component exchange or removed) described using Kaplan-Meier curve with 95% confidence interval. Minimum-maximum values: 0-100. Best result: 100.

  15 months

• Radiographic Cup Osseointegration

  Osseointegrated cups described using the Moore's criteria: the cup is osseointegrated when at least 3 criteria are present (radial trabeculae, superolateral buttress, inferolateral buttress, medial stress shielding, absence of radiolucent lines).

  15 months

• Radiographic Stem Osseointegration

  Osseointegrated stems described according to Engh's criteria

  15 months

Study Arms (1)

Congenital hip pathologies

Conical tapered stem for osteoarthritis due to congenital hip pathologies

Device: Conical tapered stem

Interventions

Conical tapered stem DEVICE

Implantation of conical tapered stem

Congenital hip pathologies

Eligibility Criteria

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

Study Population

retrospective, consecutive adult population treated with conical tapered stems in cementless total hip arthroplasty for osteoarthritis due to congenital hip pathologies.

You may qualify if:

• Symptomatic hip osteoarthritis due to congenital hip pathologies
• Consecutive population with a minimum follow-up of 2 years
• Cementless total hip arthroplasty with conical tapered stem
• Pre-operative planning using CT
• Complete clinical and radiographic assessment

You may not qualify if:

• Other type of hip osteoarthritis
• Other type of implants
• Inadequate pre-operative planning (eg: no CT)
• Incomplete clinical and radiographic assessment

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Chirurgia Protesica e dei Reimpianti di Anca e Ginocchio, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy

Bologna, 40136, Italy

Location

Related Publications (5)

• Greber EM, Pelt CE, Gililland JM, Anderson MB, Erickson JA, Peters CL. Challenges in Total Hip Arthroplasty in the Setting of Developmental Dysplasia of the Hip. J Arthroplasty. 2017 Sep;32(9S):S38-S44. doi: 10.1016/j.arth.2017.02.024. Epub 2017 Feb 22.

  PMID: 28291651 RESULT

• Perry KI, Berry DJ. Femoral considerations for total hip replacement in hip dysplasia. Orthop Clin North Am. 2012 Jul;43(3):377-86. doi: 10.1016/j.ocl.2012.05.010.

  PMID: 22819165 RESULT

• Argenson JN, Flecher X, Parratte S, Aubaniac JM. Anatomy of the dysplastic hip and consequences for total hip arthroplasty. Clin Orthop Relat Res. 2007 Dec;465:40-5. doi: 10.1097/BLO.0b013e3181576052.

  PMID: 17906591 RESULT

• Pak P, de Steiger R. Cone femoral prosthesis for osteoarthritis of the hip with femoral dysplasia. J Orthop Surg (Hong Kong). 2008 Aug;16(2):206-10. doi: 10.1177/230949900801600216.

  PMID: 18725674 RESULT

• Taniguchi N, Jinno T, Koga D, Hagino T, Okawa A, Haro H. Cementless Hip Stem Anteversion in the Dysplastic Hip: A Comparison of Tapered Wedge vs Metaphyseal Filling. J Arthroplasty. 2017 May;32(5):1547-1552. doi: 10.1016/j.arth.2016.12.020. Epub 2016 Dec 22.

  PMID: 28110848 RESULT

MeSH Terms

Conditions

Hip Dislocation; Prosthesis Failure

Condition Hierarchy (Ancestors)

Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Hip Injuries; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr Francesco Castagnini
• Organization: IRCCS Istituto Ortopedico Rizzoli

francescocastagnini@hotmail.it

+390516366418

Study Officials

• Francesco Traina, Prof

  IRCCS Istituto Ortopedico Rizzoli, Bologna, ITaly

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2020
• First Posted: February 10, 2021
• Study Start: July 17, 2020
• Primary Completion: October 1, 2021
• Study Completion: October 2, 2021
• Last Updated: March 22, 2022
• Results First Posted: March 22, 2022

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)