MINIMALLY INVASIVE SURGERY in Total Knee Arthroplasty

NCT00853398 | Terminated Phase 4

• 1 other identifier: MIS_GEN_II_6112003
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Overall study design: A prospective, randomized, multi-center clinical studies comparing the minimal invasive and the standard surgical total knee replacement technique (control) using the Genesis II total knee system. The study will collect efficacy, safety and socio-economical data over 2 years. An additional 5 years follow-up interval is optional. The objectives (short-term follow-up) of the study are to:

1. 1.Assess whether the improvement in Pain and Range of motion per Knee Society scoring system and VAS score.
2. 2.Assess whether there are any differences between the surgical techniques as regards complication rate.
3. 3.Assess whether the hospital stay and the rehabilitation time (Straight leg raise, Active/passive ROM) of the patients differs between the two techniques.
4. 4.Assess the x-ray mechanical alignment between the two techniques.
5. 5.Improvement in Pain and Function per Knee Society Scoring system
6. 6.Number and Extent of Radiographic Lucencies \>2mm
7. 7.Revision and knee-related adverse events
8. 8.Improvement in Quality-of-life via the VAS score

Conditions

Osteoarthritis of the Knee

Keywords

Primary Osteoarthritis of the knee.

Outcome Measures

Primary Outcomes (1)

• Pain and Range of Motion on the short term as efficacy measurements. Occurence of Adverse Events as safety measurements

  1 year

Secondary Outcomes (1)

• Occurence of Adverse Events and Radiolucent lines > 2mm Range of motion on the mid term

  2 years

Study Arms (2)

Minimal Invasive Surgery,

EXPERIMENTAL

Procedure: surgical technique

Standard Surgical Technique

ACTIVE COMPARATOR

Procedure: surgical technique

Interventions

surgical technique PROCEDURE

Minimal Invasive Surgery,; Standard Surgical Technique

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• require primary uni- or bilateral total knee arthroplasty; available for 2 year follow up; provide informed consent; is in stable health for cardio-pulmonary conditions.

You may not qualify if:

• inefficient femoral or tibial bone stock; BMI \>35; fixed flexion deformity \>15 degrees; knee flexion of \<90 degrees; varus/valgus deformity \>20 degrees; active local infection; conditions that would compromise the 2 years follow up.

Sponsors & Collaborators

• Smith & Nephew Orthopaedics AG: lead

Study Sites (1)

Orthopaedic Department, University Hospital

Tübingen, 72076, Germany

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Wound Closure Techniques

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: phase 4
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 27, 2009
• First Posted: March 2, 2009
• Study Start: October 1, 2004
• Primary Completion: October 1, 2007
• Study Completion: December 1, 2007
• Last Updated: May 23, 2014

Record last verified: 2014-05

Locations

DE (1)