The biodegradable spacer as a novel treatment modality for massive rotator cuff tears: a prospective study with 5-year follow-up.

BACKGROUND: The management of massive, irreparable rotator cuff tears (RCT) is challenging and associated with high failure rates. There are no current consensus or definitive guidelines concerning the optimal surgical treatment for this devastating condition. This study was designed to confirm the long-term safety and efficacy of the biodegradable inflatable InSpace™ system in patients with massive reparable or irreparable RCTs. METHODS: In this open-label, single arm, prospective study, subjects with massive RCT underwent subacromial implantation with the biodegradable spacer. Follow-up visits were scheduled according to routine clinical practice. Shoulder function was evaluated using Total Constant Score (TCS). RESULTS: Twenty-four patients were treated and assessed. Four patients had partial tears, and in three of them RC repair was performed. These patients were not included in the efficacy analyses. Of the participating subjects who reached the 5-year follow-up, 84.6% of the patients showed a clinically significant improvement of at least 15 points in their score, while 61.54% showed at least 25 points of improvement. Only 10% of the treated patients showed no improvement or worsening in the shoulder score comparing to their baseline. An overall improvement in the total CS commencing at 3 months and sustained by 6 months through to 5 years of follow-up (P < 0.0001) was demonstrated. CONCLUSIONS: We conclude that in this initial cohort, arthroscopic implantation of InSpace™ system represented an effective alternative to the existing arthroscopic procedures in patients with painful massive RCT refractory to conservative management. Further randomized controlled trials comparing the clinical and functional outcomes after implantation of the InSpace™ device are warranted.

Magnetic resonance arthrography of the hip: prevalence of diagnoses not suspected by the referring physician and correlation with clinical examination and pain score.

BACKGROUND: Magnetic resonance arthrography (MRA) of the hip is the most sensitive imaging modality for intra-articular pathologies such as labral tears. PURPOSE: To evaluate the prevalence of non-suspected pathologies revealed by hip MRA and correlate them to physical examination/pain level. MATERIAL AND METHODS: All hip MRAs (2011-2013) were retrospectively evaluated for intra- and extra-articular pathologies in consensus by two readers. A clinical score (0-7)/pain score (0-10) was calculated for each patient based on orthopedic test results extracted from referral forms/a telephone questionnaire. Patients were divided into four groups according to MRA findings: intra-articular expected (targeted) pathology only; intra-articular targeted and additional non-targeted (unexpected) pathology; non-targeted pathology; and no pathology. Pathologies prevalence/clinical score/pain score were compared between the groups. RESULTS: A total of 229 MRAs were included (127 men, 102 women; mean age, 36.5 ± 14.17 years): 111(48.4%) patients had solely intra-articular targeted pathology. Significant non-targeted pathologies were detected in 76 (33%) patients (targeted and non-targeted, 51; non-targeted only 25). No significant pathology was detected in 42 patients (18%). Mean physical examination score was 2.77 ± 1.77, range 0-7. There was no significant difference or correlation (r = 0.017, P = 0.804) between the clinical scores of the different MRA pathology groups. Pain score (143 patients) was significantly higher in the non-targeted pathology group compared to the targeted and non-targeted group (P = 0.04) and to the no pathology group (P = 0.04). There was no correlation between the physical examination score and the pain score (r = 0.017, P = 0.804). CONCLUSION: Unsuspected non-targeted pathologies were detected in 33% of hip MRA. Physical examination/pain level could not differentiate between patients.

Partial lateral patellar facetectomy as an alternative to lateral release in Total Knee Arthroplasty (TKA).

This study presents the selective use of partial patellar lateral facetectomy for maltracking during primary TKA, as an alternative to lateral release. Twenty three partial facetectomies were performed out of 191 TKAs (12%). Balanced tracking was achieved in 22 knees. At follow-up 2 patients had persistent anterior knee pain. Mean Knee Society score (KSS) was 94 and mean functional KSS was 86. Mean patellar score was 28. Patellar tilt angles were within 2 degrees in all but one knee. Patellar translation was within 2 mm in all cases. No complications were recorded. A control group of 46 matched patients had similar functional and radiographic results. If tracking is not satisfactory at the conclusion of TKA, our method of choice would be partial lateral facetectomy.

Prospective clinical study of a novel biodegradable sub-acromial spacer in treatment of massive irreparable rotator cuff tears.

PURPOSE: The purposes of this prospective non-randomized study were to confirm the feasibility of the biodegradable sub-acromial spacer (InSpace™) implantation in patients with massive irreparable rotator cuff tear and to determine the safety profile and functional results 3 years post-implantation. METHODS: Twenty patients were implanted with the InSpace™ device and assessed up to 3 years of post-implantation. Improvement in shoulder function was assessed using Constant score, while ease of use of the system was recorded by surgeons as were device-related adverse events. RESULTS: Twenty patients were available for assessment. Implantation was performed arthroscopically in all patients, and a range of deployment time was 2-20 min. The mean total Constant score increased from 33.4 to 65.4 points at 3 years. There was an improvement of 6.4 points in subjective pain score which commenced at 1 week post-operatively and was sustained until 3 years of follow-up. Also activities of daily living and motions commenced improvement by 9.4 and 7.7 points, respectively. Improvement in power was only evident at 18 months of follow-up but was sustained at 3 years. CONCLUSIONS: Arthroscopic deployment of a co-polymer biodegradable spacer (balloon) into the sub-acromial space for an irreparable rotator cuff tear was found to be low-risk and simple procedure associated with improvement in shoulder function and low rate of complications. LEVEL OF EVIDENCE: IV; therapeutic case series.

[Guidelines for wise utilization of knee imaging].

BACKGROUND: The knee is a complex structure afflicted with diverse pathologies. Correct management of knee complaints demands wise utilization of imaging modalities, considering their accuracy in the specific clinical situation, the patient's safety and availability and financial issues. Some of these considerations are universal, while others are local, depending on medical and insurance systems. There is controversy and unclearness regarding the best imaging modality in different clinical situations. PURPOSE: To develop clinical guidelines for utilizing knee imaging. METHODS: Leading physicians in specialties associated with knee disease and imaging were invited to participate in a panel on the guidelines. Controversies were settled in the main panel or in sub-panels. RESULTS: The panel agreed on the principles in choosing from the various modalities, primarily medical accuracy, followed by patient safety, availability and cost. There was agreement that the physician is responsible to choose the most appropriate diagnostic tool, consulting, when necessary, on the advantages, limitations and risks of the various imaging modalities. A comprehensive table was compiled with the importance of the different imaging modalities in various clinical situations. DISCUSSION AND SUMMARY: For the first time, Israeli guidelines on wise utilization of knee imaging are presented. They take into consideration the clinical situations and also availability and financial issues specific to Israel. These guidelines will serve physicians of several disciplines and medical insurers to improve patient management efficiently.

Biodegradable spacer reduces the subacromial pressure: A biomechanical cadaver study.

BACKGROUND: Failure after rotator cuff repair remains a major clinical problem and could be related to excessive pressures from the acromion. Previous studies with irreparable tears showed good clinical results of tendon healing with arthroscopic insertion of a protective biodegradable spacer balloon between the repaired tendon and the acromion. One hypothesis is that compression pressures on the repaired tendon will be reduced by the spacer. This cadaver study aimed to investigate the effects of this subacromial spacer on compression pressures over a repaired supraspinatus tendon in passive motion. METHODS: Rotator cuff tear and repair were performed in six fresh-frozen cadaveric shoulders, followed by insertion of a biodegradable subacromial spacer. Specimens were tested using a passive shoulder simulator for abduction-adduction, flexion-extension and internal-external rotations. A sensor positioned below the acromion was used to measure compression pressure changes through passive range of motion before and after placement of a subacromial spacer. Peak pressures were measured in adduction-abduction motion, near 90° abduction. FINDINGS: Both the mean and peak pressures in abduction-adduction were significantly reduced after insertion of the subacromial spacer (from mean 121.7 (SD 9.5) MPa to 51.5 (SD 1.2) MPa and from peak 1749.6 (SD 80.7) MPa to 535.1 (SD 27.6) MPa) (P<0.0001). INTERPRETATION: The reduced peak pressures and wider load distributions over the sensor during both passive abduction-adduction and flexion-extension motions suggest that the use of the spacer will lead to reduced wear of the repair in patients, and potentially prevent rotator cuff re-tear after surgical repair.

Biceps Tenotomy Does not Affect the Functional Outcomes of Patients Treated with Spacer Implantation Due to Massive Irreparable Rotator Cuff Tears.

BACKGROUND: Lesions of the long head of the biceps (LHB) tendon are frequently associated with massive rotator cuff tears (RCT) and may be responsible for shoulder pain and disability. OBJECTIVE: This study aimed to evaluate functional outcomes of arthroscopic biodegradable spacer implantation with or without biceps tenotomy as treatment for persistent shoulder dysfunction and pain due to a massive irreparable RCT. METHODS: A total of 48 patients were implanted with the subacromial spacer using arthroscopic approach with or without biceps tenotomy. All patients were assessed for up to 12 months post-implantation and 18 patients were assessed for at least 24 months (and a maximum of 40 months). Improvement in shoulder function was assessed using Constant score. RESULTS: Subacromial spacer implantation was performed arthroscopically in 48 patients. The mean total Constant score increased from 36 at baseline to 67 points at 12 months post implantation. Patients who underwent LHB tenotomy in addition to the subacromial spacer presented similar improvement of their shoulder function and score compared to the group that was treated with the spacer alone. CONCLUSION: Current study demonstrates that spacer implantation in this patient population provides significant improvement in function and decreases the pain. Additional LHB tenotomy did not influence the postoperative results during the follow-up.

The double-loop technique for meniscal suture.

The authors describe a modified method for arthroscopic meniscal repair in which polydioxanone sutures are placed in the torn meniscus using needles and nylon loops. Conventional methods require the use of expensive instruments, which are not always available. However, our method is fast and simple. This technique also simplifies inserting multiple sutures to achieve adequate stability of the torn meniscus.